Bone Marrow Aplasia, Hematologic Diseases, Thrombocytopenia
Conditions
Keywords
thrombocytopenia, bleeding
Brief summary
The study evaluates the safety and potential early signals of efficacy of allogeneic Thrombosomes in bleeding thrombocytopenic patients
Detailed description
The primary objective of the present study was to assess the safety of increasing dose levels of Thrombosomes in bleeding patients with thrombocytopenia. The secondary objective was to explore early signals of clinical efficacy of Thrombosomes in this population. The secondary objectives included: 1) Evaluation of the impact on WHO (World Health Organization) bleeding scores at various timepoints; 2) number and type of blood products infused through day 6 follow-up period; and 3) post hoc analysis of hematology, coagulation, and chemistry.
Interventions
BIOLOGICALThrombosomes
Freeze-dried platelets
Sponsors
Department of Health and Human Services
Cellphire Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Adults up to 74 y/o with any of following: acute leukemia (ALL or AML), myelodysplasia, aplasia, and/or therapy (chemotherapy or radiation) induced bone marrow aplasia or hypoplasia with thrombocytopenia (platelet count ≥ 5,000 and ≤ 70,000/μL) for a minimum of 2 days. May include bone marrow transplant or peripheral or cord blood stem cell recipients, but not subjects with Graft-vs-Host disease. * Hospitalized patients (or willing to be hospitalized for 24 hours after Rx) with Modified WHO Grade 1 (subset) or Grade 2 Bleeding Score or at risk for same within 4 weeks of screening. The Grade 1 subset includes patients who have either epistaxis, hematuria, oral petechiae, or bleeding at invasive or other wound sites. * No platelet inhibitor drugs within 5 days prior to infusion and through Day 6 follow-up period.
Exclusion criteria
* History or condition related to thrombosis, embolism or vascular occlusion/ischemia, including but not limited to: transient ischemic attack, stroke, myocardial infarction, stent placement, valve replacement and/or repair * Currently with an active acute infection, or suspected infection, a single oral temperature of ≥ 101° F or a temperature of ≥ 100.4°F sustained over a 1 h period in past 24 h. Subjects on prophylactic antibiotics are not excluded from study * Coagulopathy or receiving anticoagulants that result in PT (prothrombin time) or aPTT (activated partial thromboplastin time) values greater than 1.3 X upper limit of normal or elevated D-dimer of decreased fibrinogen * History of any inherited coagulation or platelet function, disorder or ITP (idiopathic thrombocytopenic purpura), TTP (thrombotic thrombocytopenic purpura), or HUS (hemolytic-uremic syndrome) * Receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion * Treatment with an investigational drug within 1 month of infusion, other than for treatment of their underlying disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Treatment-Emergent Adverse Events (TEAE) | 30 days | Overall frequency of (and number and percentage of patients who experience) TEAEs including serious adverse drug reactions and treatment-related events specifically defining the study's suspension and stopping rules (i.e., thromboembolic events, acute lung injury, anaphylaxis, and death). |
| Number of Patients With Treatment-Emergent Serious Adverse Events (TESAE) | 30 days | Overall frequency of (and number and percentage of patients who experience) TESAEs including serious adverse drug reactions and treatment-related events specifically defining the study's suspension and stopping rules (i.e., thromboembolic events, acute lung injury, anaphylaxis, and death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With a Shift From Baseline in Hemoglobin | 1, 6, 24 hours, Day 3, 4, 5, and 6 post infusion | Shift from baseline clinical status of hemoglobin measure at different timepoints post infusion |
| Number of Patients With a Shift From Baseline in Hematocrit | 1, 6, 24 hours, Day 3, 4, 5, and 6 post infusion | Shift from baseline clinical status of hematocrit measure at different timepoints post infusion |
| Number of WHO Bleeding Sites With Status Change From Baseline | 1, 6, 24 hours, and Day 6 post infusion | Grade-level change in WHO bleeding assessment score at most severe bleeding site from baseline; WHO bleeding assessment score ranges from 1 to 4, with higher numbers indicating worse bleeding. |
| Median Platelet Counts | Screening, Baseline, 1, 6, 24 hours, Day 3, 4, 5, and 6 post infusion | Median Platelet Counts Per Time Point |
| Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | 24 hours post infusion | Shift from baseline clinical status of coagulation measure at 24 hours post infusion for each cohort |
| Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | Baseline, 1, 6, 24 hours, and Day 6 post infusion | Patients WHO score at primary bleeding site. WHO bleeding assessment score ranges from 1 to 4, with higher numbers indicating worse bleeding. The maximum WHO bleeding assessment score for patients on study was 2. |
Countries
Norway, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Thrombosomes 94.5 Million Particles/kg Body Weight Thrombosomes: Freeze-dried platelet derived hemostatic | 8 |
| Thrombosomes 189 Million Particles/kg Body Weight Thrombosomes: Freeze-dried platelet derived hemostatic | 8 |
| 378 Million Particles/kg Body Weight Thrombosomes: Freeze-dried platelet derived hemostatic | 8 |
| Total | 24 |
Baseline characteristics
| Characteristic | Thrombosomes 94.5 Million Particles/kg Body Weight | Total | 378 Million Particles/kg Body Weight | Thrombosomes 189 Million Particles/kg Body Weight |
|---|---|---|---|---|
| Age, Continuous | 55.5 years | 59 years | 60.5 years | 59.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 21 Participants | 7 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 18 Participants | 4 Participants | 7 Participants |
| Safety Population | 8 Participants | 24 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Female | 3 Participants | 10 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 14 Participants | 5 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 3 / 8 | 3 / 8 |
| other Total, other adverse events | 7 / 8 | 6 / 8 | 5 / 8 |
| serious Total, serious adverse events | 1 / 8 | 5 / 8 | 4 / 8 |
Outcome results
Primary
Number of Patients With Treatment-Emergent Adverse Events (TEAE)
Overall frequency of (and number and percentage of patients who experience) TEAEs including serious adverse drug reactions and treatment-related events specifically defining the study's suspension and stopping rules (i.e., thromboembolic events, acute lung injury, anaphylaxis, and death).
Time frame: 30 days
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With Treatment-Emergent Adverse Events (TEAE) | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With Treatment-Emergent Adverse Events (TEAE) | 6 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With Treatment-Emergent Adverse Events (TEAE) | 5 Participants |
Primary
Number of Patients With Treatment-Emergent Serious Adverse Events (TESAE)
Overall frequency of (and number and percentage of patients who experience) TESAEs including serious adverse drug reactions and treatment-related events specifically defining the study's suspension and stopping rules (i.e., thromboembolic events, acute lung injury, anaphylaxis, and death).
Time frame: 30 days
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With Treatment-Emergent Serious Adverse Events (TESAE) | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With Treatment-Emergent Serious Adverse Events (TESAE) | 5 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With Treatment-Emergent Serious Adverse Events (TESAE) | 4 Participants |
Secondary
Median Platelet Counts
Median Platelet Counts Per Time Point
Time frame: Screening, Baseline, 1, 6, 24 hours, Day 3, 4, 5, and 6 post infusion
Population: The median platelet count of the safety patient population is grouped by timepoints(screening, baseline and post infusion 1, 6, 24 hours, Day 3, 4, 5, 6) rather than by treatment arms.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Thrombosomes 94.5 Million Particles/kg Body Weight | Median Platelet Counts | Screening | 16 PLT Count (10³/µl) |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Median Platelet Counts | Baseline | 18.5 PLT Count (10³/µl) |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Median Platelet Counts | 1 hour post infusion | 13.5 PLT Count (10³/µl) |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Median Platelet Counts | 6 hrs post infusion | 14 PLT Count (10³/µl) |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Median Platelet Counts | 24 hrs post infusion | 20.5 PLT Count (10³/µl) |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Median Platelet Counts | Day 3 | 22.5 PLT Count (10³/µl) |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Median Platelet Counts | Day 4 | 18.5 PLT Count (10³/µl) |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Median Platelet Counts | Day 5 | 20 PLT Count (10³/µl) |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Median Platelet Counts | Day 6 | 18 PLT Count (10³/µl) |
Secondary
Number of Patients With a Shift From Baseline in Hematocrit
Shift from baseline clinical status of hematocrit measure at different timepoints post infusion
Time frame: 1, 6, 24 hours, Day 3, 4, 5, and 6 post infusion
Population: Safety population with available data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal NCS>Abnormal CS | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal NCS>Abnormal NCS | 7 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal NCS>Abnormal NCS | 6 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal CS>Abnormal NCS | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal CS>Abnormal NCS | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal NCS>Abnormal NCS | 7 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal NCS>Abnormal CS | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal NCS>Abnormal NCS | 7 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal CS>Abnormal NCS | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal NCS>Abnormal NCS | 5 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal NCS>Abnormal NCS | 6 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal NCS>Abnormal NCS | 7 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal NCS>Abnormal CS | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal NCS>Abnormal NCS | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal CS>Abnormal CS | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal NCS>Abnormal NCS | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal CS>Abnormal NCS | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal NCS>Abnormal NCS | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal CS>Abnormal NCS | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal NCS>Abnormal NCS | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal NCS>Abnormal NCS | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal CS>Abnormal NCS | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal CS>Abnormal NCS | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal NCS>Abnormal NCS | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal CS>Abnormal CS | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal NCS>Abnormal NCS | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal CS>Abnormal NCS | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal NCS>Abnormal NCS | 7 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal NCS>Abnormal NCS | 8 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal NCS>Abnormal NCS | 5 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal NCS>Abnormal NCS | 8 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal NCS>Abnormal NCS | 6 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 6 hours post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 5 | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 3 | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal CS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal CS>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Abnormal CS>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Normal>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal NCS>Abnormal CS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 1 hour post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal NCS>Abnormal NCS | 8 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal NCS>Abnormal NCS | 5 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | 24 hours post infusion | Abnormal NCS> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 6 | Normal>Abnormal NCS | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hematocrit | Day 4 | Abnormal NCS>Abnormal CS | 0 Participants |
Secondary
Number of Patients With a Shift From Baseline in Hemoglobin
Shift from baseline clinical status of hemoglobin measure at different timepoints post infusion
Time frame: 1, 6, 24 hours, Day 3, 4, 5, and 6 post infusion
Population: Safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 2 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 4 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 7 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Clinically Significant>Abnormal Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Clinically Significant>Abnormal Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 6 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 2 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 6 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 5 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 4 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 5 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Clinically Significant>Abnormal Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Clinically Significant>Abnormal Clinically Significant | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Clinically Significant>Abnormal Clinically Significant | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Clinically Significant>Abnormal Clinically Significant | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 7 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 7 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 8 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 5 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 6 hours post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 6 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 5 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 3 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 8 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 6 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 24 hours post infusion | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | 1 hour post infusion | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With a Shift From Baseline in Hemoglobin | Day 4 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 5 Participants |
Secondary
Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site
Patients WHO score at primary bleeding site. WHO bleeding assessment score ranges from 1 to 4, with higher numbers indicating worse bleeding. The maximum WHO bleeding assessment score for patients on study was 2.
Time frame: Baseline, 1, 6, 24 hours, and Day 6 post infusion
Population: The evaluable patient population is grouped by WHO grade levels 0, 1, and 2 rather than by treatment arms.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | 24 hours post infusion | 4 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | 6 hours post infusion | 3 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | Baseline | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | 1 hour post infusion | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | Day 6 | 8 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | 6 hours post infusion | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | Baseline | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | 1 hour post infusion | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | 24 hours post infusion | 6 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | Day 6 | 6 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | Day 6 | 8 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | 24 hours post infusion | 12 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | Baseline | 15 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | 6 hours post infusion | 12 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site | 1 hour post infusion | 14 Participants |
Secondary
Number of WHO Bleeding Sites With Status Change From Baseline
Grade-level change in WHO bleeding assessment score at most severe bleeding site from baseline; WHO bleeding assessment score ranges from 1 to 4, with higher numbers indicating worse bleeding.
Time frame: 1, 6, 24 hours, and Day 6 post infusion
Population: All bleeding sites among the evaluable patient population were grouped into a change in WHO bleeding status rather than by treatment arms.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of WHO Bleeding Sites With Status Change From Baseline | 1 hour post infusion | 0 Total bleeding sites |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of WHO Bleeding Sites With Status Change From Baseline | 6hrs post infusion | 0 Total bleeding sites |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of WHO Bleeding Sites With Status Change From Baseline | 24 hours post infusion | 0 Total bleeding sites |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number of WHO Bleeding Sites With Status Change From Baseline | Day 6 | 0 Total bleeding sites |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of WHO Bleeding Sites With Status Change From Baseline | Day 6 | 10 Total bleeding sites |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of WHO Bleeding Sites With Status Change From Baseline | 1 hour post infusion | 24 Total bleeding sites |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of WHO Bleeding Sites With Status Change From Baseline | 24 hours post infusion | 17 Total bleeding sites |
| Thrombosomes 189 Million Particles/kg Body Weight | Number of WHO Bleeding Sites With Status Change From Baseline | 6hrs post infusion | 21 Total bleeding sites |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of WHO Bleeding Sites With Status Change From Baseline | Day 6 | 17 Total bleeding sites |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of WHO Bleeding Sites With Status Change From Baseline | 6hrs post infusion | 6 Total bleeding sites |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of WHO Bleeding Sites With Status Change From Baseline | 24 hours post infusion | 10 Total bleeding sites |
| Thrombosomes 378 Million Particles/kg Body Weight | Number of WHO Bleeding Sites With Status Change From Baseline | 1 hour post infusion | 3 Total bleeding sites |
Secondary
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Shift from baseline clinical status of coagulation measure at 24 hours post infusion for each cohort
Time frame: 24 hours post infusion
Population: Safety population with available data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Normal>Normal | 7 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Clinically Significant>Abnormal Clinically Significant | 2 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Clinically Significant>Abnormal Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Normal>Normal | 2 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Normal>Normal | 7 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Normal>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 3 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 4 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Normal>Normal | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Clinically Significant>Abnormal Clinically Significant | 2 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Normal>Normal | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 2 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 4 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Not Clinically Significant> Normal | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Not Clinically Significant> Normal | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Normal>Normal | 7 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Normal>Normal | 2 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Normal>Normal | 6 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Normal>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Not Clinically Significant> Normal | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 3 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Normal>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Normal>Normal | 5 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Normal>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Normal>Normal | 7 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 6 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 94.5 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Normal>Normal | 5 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Normal>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Normal>Normal | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Normal>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Normal>Normal | 6 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 2 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Normal>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Not Clinically Significant> Normal | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Normal>Normal | 5 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 3 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Normal>Normal | 2 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Normal>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Not Clinically Significant> Normal | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 4 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Normal>Normal | 2 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Normal>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 4 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Normal>Normal | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Normal>Normal | 6 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Not Clinically Significant> Normal | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Normal>Normal | 7 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Normal>Normal | 6 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Not Clinically Significant> Normal | 1 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 189 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 6 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Normal>Normal | 6 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Normal>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Normal>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Normal>Normal | 5 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Normal>Normal | 4 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Normal>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Normal>Normal | 6 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Abnormal Not Clinically Significant> Normal | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 3 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Normal>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Activated Partial Thromboplastin Time (aPTT) | Normal>Normal | 4 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Time to Peak) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Normal>Normal | 7 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 5 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Normal>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Normal>Normal | 2 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Normal>Abnormal Not Clinically Significant | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Antithrombin (TAT) | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Normal>Normal | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 3 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Not Clinically Significant> Normal | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Abnormal Not Clinically Significant> Normal | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Not Clinically Significant> Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Not Clinically Significant> Normal | 3 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Abnormal Not Clinically Significant> Normal | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 4 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Time (PT) | Abnormal Not Clinically Significant> Normal | 1 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Fibrinogen | Normal>Normal | 3 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Not Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Normal>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) | Abnormal Clinically Significant>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Prothrombin Fragment (PF) 1+2 | Abnormal Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Clinically Significant>Normal | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Thrombin Peak Height) | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Normal>Normal | 7 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | D-dimer | Abnormal Not Clinically Significant>Abnormal Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | International Normalized Ratio (INR) | Normal>Abnormal Not Clinically Significant | 0 Participants |
| Thrombosomes 378 Million Particles/kg Body Weight | Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion | Thrombin Generation Assay (TGA) (Lag Time) | Normal>Abnormal Not Clinically Significant | 0 Participants |