Thrombocytopenia
Conditions
Keywords
platelet transfusion
Brief summary
This study is to evaluate the safety of intravenous (IV) infusion of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) in participants with World Health Organization (WHO) Grade 2 bleed in spite of receiving a transfusion of liquid stored platelets (LSP) in the past 48 hours by collecting adverse events (AEs) and by evaluating coagulation-related parameters to assess the evidence of any thrombotic events after CPP or LSP transfusion.
Detailed description
After determining eligibility for study participation, 4 sequential cohorts of subjects will receive escalating doses of CPP (Test) or 1 unit of LSP (Control) randomized 6:1 within each cohort. Each sequential cohort will receive the following transfusions starting with the first cohort: 0.5, 1, 2, and 3 units of CPP with an additional single subject in each cohort who will receive 1 unit of LSP for a total of 28 subjects. Assignment to Test and Control platelets for subjects in each cohort will be centrally randomized using an interactive web response system (IWRS). Following the study transfusion, subjects are followed for evidence of transfusion reactions, thrombotic events, other AEs, coagulation-related parameters, and platelet efficacy endpoints. CPP or LSP will be transfused into a patient according to the randomized product and dose assignment within the cohort. Following the transfusion, subjects are followed for the remainder of Study Day 1 and on Study Day 2 for AEs and tested for coagulation markers including fibrinogen, D-dimer, prothrombin fragments 1 + 2 (F 1+2), thrombin antithrombin (TAT), anti-thrombin (AT), prothrombin time (PT), activated partial thromboplastin time (aPTT), thrombin generation testing (TGT) results, thromboelastography (TEG) results, and other potential complications of platelet transfusion such as transfusion reactions and thrombotic events including assessment of vital signs (blood pressure, heart rate, respiration rate, and pulse oximetry). A subject is considered to have completed the study for safety evaluation for dose escalation, if he/she receives a study infusion and completed study-related Day 3 procedures.
Interventions
BIOLOGICALCPP
One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
BIOLOGICALLSP
Sponsors
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, at least 18 years of age. * Ability to comprehend the study procedures and signed informed consent. * If pre-menopausal female, must have a negative serum pregnancy test, and, if of child bearing potential, must be using an acceptable method of contraception. * Diagnosed with any the following: acute leukemia (ALL or AML), chronic leukemia (CML, CLL, CMML, or hairy cell leukemia), myelodysplasia, aplasia, hematopoietic or non-hematopoietic solid tumor, or therapy (chemotherapy or radiation) induced bone marrow aplasia or hypoplasia. Either autologous or allogeneic bone marrow transplant or peripheral or cord blood stem cell recipients may be enrolled. * WHO grade 2 or greater bleeding.
Exclusion criteria
* Acute or chronic DIC as evidence by D-dimer greater than 8 μg/mL and fibrinogen less than 100 mg (0.1 g)/dL. Both criteria must be met. If data are in the medical record for fibrin degradation products (FDPs), then FDP must be \<=40 μg/mL (FDP \>40 μg/mL is indicative of DIC). * PT or aPTT \> 1.3 times the upper limit of normal for the laboratory. * History of major operative procedures that required general anesthesia in the past 2 weeks. * History of any prior major unprovoked thrombotic events and/or known inherited disorder of coagulation or platelet function (by history) (not to include clots in catheters, etc). * A history or diagnosis of immune thrombocytopenia, thrombotic thrombocytopenic purpura, or hemolytic uremic syndrome. * Females who are breastfeeding. * Veno-occlusive disease or possible veno-occlusive disease. * Receiving active, inpatient treatment with anti-platelet drugs and/or full anticoagulation therapy. Note: a heparin flush may be given daily and before and after blood draws to patients with a central line to keep the line patent. * Subject previously enrolled in this study and received a study transfusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) by Level of Severity | day of thru 6 days after transfusion | Clinical laboratory \[chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)\] parameters, physical examination findings, electrocardiogram (ECG)\] and vital sign AEs summarized by severity. |
| Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | day of thru 6 days after transfusion | Number of subjects who experienced AEs at specific levels of severity. Clinical laboratory \[chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)\] parameters, physical examination findings, electrocardiogram (ECG)\] and vital signs were evaluated. |
| Number of Subject With Thrombotic Events | 6 days after transfusion | Subjects with any signs or symptoms of thrombotic events. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Corrected Count Increments (CCI) | Day 1 up to 6 hrs after transfusion and Day 2 approx 24 hrs after transfusion | Corrected Count Increments Expressed in units of mm\^2/(µL\*10¹¹ platelets) (CCI) in the 6 hour period after the study platelet transfusion and on Day 2 (approximately 24 hours after the study platelet transfusion) |
| Count Increment | On Day 1 up to 6 hours after transfusion and on Day 2 approximately 24 hours after transfusion | Count Increment expressed in units of platelets (x10\^3 µL) (CI) |
Countries
United States
Participant flow
Recruitment details
Patients who were admitted to the site's medical center and undergoing treatment for a hematologic malignancy were potentially eligible for the study. Potential study subjects were recruited by preliminary medical chart review against the study eligibility criteria.
Pre-assignment details
Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1 Unit CPP group.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 With 0.5 Units of CPP A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. | 5 |
| Cohort 2 With 1 Unit of CPP A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. | 7 |
| Cohort 3 With 2 Units of CPP A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. | 6 |
| Cohort 4 With 3 Units of CPP A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. | 6 |
| 1 Unit of LSP A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP) | 4 |
| Total | 28 |
Baseline characteristics
| Characteristic | Cohort 2 With 1 Unit of CPP | Cohort 3 With 2 Units of CPP | Cohort 4 With 3 Units of CPP | Cohort 1 With 0.5 Units of CPP | 1 Unit of LSP | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 18.6 | 52.3 years STANDARD_DEVIATION 15.8 | 53.3 years STANDARD_DEVIATION 13 | 46.0 years STANDARD_DEVIATION 17.3 | 46.3 years STANDARD_DEVIATION 16.2 | 51.9 years STANDARD_DEVIATION 15.8 |
| Baseline Height (cm) | 172 cm STANDARD_DEVIATION 8.55 | 176 cm STANDARD_DEVIATION 11.7 | 180 cm STANDARD_DEVIATION 11.6 | 171 cm STANDARD_DEVIATION 2.77 | 177 cm STANDARD_DEVIATION 13.4 | 175.2 cm STANDARD_DEVIATION 10 |
| Baseline Weight (kg) | 87.2 kg STANDARD_DEVIATION 23.9 | 87.7 kg STANDARD_DEVIATION 28.3 | 97.8 kg STANDARD_DEVIATION 16.4 | 91.4 kg STANDARD_DEVIATION 15.3 | 81.1 kg STANDARD_DEVIATION 11.4 | 89.5 kg STANDARD_DEVIATION 20.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 5 Participants | 6 Participants | 5 Participants | 4 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 4 Participants | 5 Participants | 4 Participants | 2 Participants | 21 Participants |
| Region of Enrollment United States | 7 participants | 6 participants | 6 participants | 5 participants | 4 participants | 28 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 11 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 5 Participants | 1 Participants | 3 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 5 | 1 / 7 | 0 / 6 | 1 / 6 | 0 / 4 |
| other Total, other adverse events | 4 / 5 | 6 / 7 | 3 / 6 | 5 / 6 | 1 / 4 |
| serious Total, serious adverse events | 1 / 5 | 2 / 7 | 0 / 6 | 2 / 6 | 0 / 4 |
Outcome results
Primary
Adverse Events (AEs) by Level of Severity
Clinical laboratory \[chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)\] parameters, physical examination findings, electrocardiogram (ECG)\] and vital sign AEs summarized by severity.
Time frame: day of thru 6 days after transfusion
Population: Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1 Unit CPP group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 With 0.5 Units of CPP | Adverse Events (AEs) by Level of Severity | Total Severe AEs | 0 adverse events |
| Cohort 1 With 0.5 Units of CPP | Adverse Events (AEs) by Level of Severity | Total number of AEs | 8 adverse events |
| Cohort 1 With 0.5 Units of CPP | Adverse Events (AEs) by Level of Severity | Total Life-threatening or Fatal AEs | 1 adverse events |
| Cohort 1 With 0.5 Units of CPP | Adverse Events (AEs) by Level of Severity | Total mild AEs | 6 adverse events |
| Cohort 1 With 0.5 Units of CPP | Adverse Events (AEs) by Level of Severity | Total moderate AEs | 1 adverse events |
| Cohort 2 With 1 Unit of CPP | Adverse Events (AEs) by Level of Severity | Total Severe AEs | 1 adverse events |
| Cohort 2 With 1 Unit of CPP | Adverse Events (AEs) by Level of Severity | Total moderate AEs | 3 adverse events |
| Cohort 2 With 1 Unit of CPP | Adverse Events (AEs) by Level of Severity | Total mild AEs | 11 adverse events |
| Cohort 2 With 1 Unit of CPP | Adverse Events (AEs) by Level of Severity | Total Life-threatening or Fatal AEs | 3 adverse events |
| Cohort 2 With 1 Unit of CPP | Adverse Events (AEs) by Level of Severity | Total number of AEs | 18 adverse events |
| Cohort 3 With 2 Units of CPP | Adverse Events (AEs) by Level of Severity | Total moderate AEs | 5 adverse events |
| Cohort 3 With 2 Units of CPP | Adverse Events (AEs) by Level of Severity | Total number of AEs | 6 adverse events |
| Cohort 3 With 2 Units of CPP | Adverse Events (AEs) by Level of Severity | Total mild AEs | 1 adverse events |
| Cohort 3 With 2 Units of CPP | Adverse Events (AEs) by Level of Severity | Total Severe AEs | 0 adverse events |
| Cohort 3 With 2 Units of CPP | Adverse Events (AEs) by Level of Severity | Total Life-threatening or Fatal AEs | 0 adverse events |
| Cohort 4 With 3 Units of CPP | Adverse Events (AEs) by Level of Severity | Total Life-threatening or Fatal AEs | 6 adverse events |
| Cohort 4 With 3 Units of CPP | Adverse Events (AEs) by Level of Severity | Total number of AEs | 21 adverse events |
| Cohort 4 With 3 Units of CPP | Adverse Events (AEs) by Level of Severity | Total Severe AEs | 1 adverse events |
| Cohort 4 With 3 Units of CPP | Adverse Events (AEs) by Level of Severity | Total moderate AEs | 5 adverse events |
| Cohort 4 With 3 Units of CPP | Adverse Events (AEs) by Level of Severity | Total mild AEs | 9 adverse events |
| 1 Unit of LSP | Adverse Events (AEs) by Level of Severity | Total moderate AEs | 0 adverse events |
| 1 Unit of LSP | Adverse Events (AEs) by Level of Severity | Total Severe AEs | 0 adverse events |
| 1 Unit of LSP | Adverse Events (AEs) by Level of Severity | Total number of AEs | 5 adverse events |
| 1 Unit of LSP | Adverse Events (AEs) by Level of Severity | Total Life-threatening or Fatal AEs | 0 adverse events |
| 1 Unit of LSP | Adverse Events (AEs) by Level of Severity | Total mild AEs | 5 adverse events |
Primary
Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity
Number of subjects who experienced AEs at specific levels of severity. Clinical laboratory \[chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)\] parameters, physical examination findings, electrocardiogram (ECG)\] and vital signs were evaluated.
Time frame: day of thru 6 days after transfusion
Population: Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1 Unit CPP group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 With 0.5 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Any AE | 4 Participants |
| Cohort 1 With 0.5 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Related to Investigational Product | 1 Participants |
| Cohort 1 With 0.5 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Life-threatening or Fatal AEs | 1 Participants |
| Cohort 1 With 0.5 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Mild AEs | 4 Participants |
| Cohort 1 With 0.5 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with any AE | 4 Participants |
| Cohort 1 With 0.5 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Moderate AEs | 1 Participants |
| Cohort 1 With 0.5 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Severe AEss | 0 Participants |
| Cohort 2 With 1 Unit of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Severe AEss | 1 Participants |
| Cohort 2 With 1 Unit of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Moderate AEs | 1 Participants |
| Cohort 2 With 1 Unit of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with any AE | 6 Participants |
| Cohort 2 With 1 Unit of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Any AE | 6 Participants |
| Cohort 2 With 1 Unit of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Life-threatening or Fatal AEs | 1 Participants |
| Cohort 2 With 1 Unit of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Mild AEs | 4 Participants |
| Cohort 2 With 1 Unit of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Related to Investigational Product | 2 Participants |
| Cohort 3 With 2 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Moderate AEs | 3 Participants |
| Cohort 3 With 2 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Any AE | 3 Participants |
| Cohort 3 With 2 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with any AE | 3 Participants |
| Cohort 3 With 2 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Mild AEs | 1 Participants |
| Cohort 3 With 2 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Severe AEss | 0 Participants |
| Cohort 3 With 2 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Life-threatening or Fatal AEs | 2 Participants |
| Cohort 3 With 2 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Related to Investigational Product | 2 Participants |
| Cohort 4 With 3 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Mild AEs | 5 Participants |
| Cohort 4 With 3 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Severe AEss | 1 Participants |
| Cohort 4 With 3 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with any AE | 5 Participants |
| Cohort 4 With 3 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Related to Investigational Product | 2 Participants |
| Cohort 4 With 3 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Life-threatening or Fatal AEs | 2 Participants |
| Cohort 4 With 3 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Any AE | 5 Participants |
| Cohort 4 With 3 Units of CPP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Moderate AEs | 1 Participants |
| 1 Unit of LSP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Mild AEs | 1 Participants |
| 1 Unit of LSP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Related to Investigational Product | 0 Participants |
| 1 Unit of LSP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Life-threatening or Fatal AEs | 0 Participants |
| 1 Unit of LSP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Severe AEss | 0 Participants |
| 1 Unit of LSP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with any AE | 1 Participants |
| 1 Unit of LSP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Any AE | 1 Participants |
| 1 Unit of LSP | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Total Patients with Moderate AEs | 0 Participants |
Primary
Number of Subject With Thrombotic Events
Subjects with any signs or symptoms of thrombotic events.
Time frame: 6 days after transfusion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 With 0.5 Units of CPP | Number of Subject With Thrombotic Events | 0 Participants |
| Cohort 2 With 1 Unit of CPP | Number of Subject With Thrombotic Events | 0 Participants |
| Cohort 3 With 2 Units of CPP | Number of Subject With Thrombotic Events | 0 Participants |
| Cohort 4 With 3 Units of CPP | Number of Subject With Thrombotic Events | 0 Participants |
| 1 Unit of LSP | Number of Subject With Thrombotic Events | 0 Participants |
Other Pre-specified
Corrected Count Increments (CCI)
Corrected Count Increments Expressed in units of mm\^2/(µL\*10¹¹ platelets) (CCI) in the 6 hour period after the study platelet transfusion and on Day 2 (approximately 24 hours after the study platelet transfusion)
Time frame: Day 1 up to 6 hrs after transfusion and Day 2 approx 24 hrs after transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 With 0.5 Units of CPP | Corrected Count Increments (CCI) | CII: Day 1 up to 6 hrs after | 2.40 mm^2/(μL*1011 platelets) | Standard Deviation 5.76 |
| Cohort 1 With 0.5 Units of CPP | Corrected Count Increments (CCI) | CII: Day 2 | 5.19 mm^2/(μL*1011 platelets) | Standard Deviation 6.22 |
| Cohort 2 With 1 Unit of CPP | Corrected Count Increments (CCI) | CII: Day 1 up to 6 hrs after | 3.10 mm^2/(μL*1011 platelets) | Standard Deviation 2.92 |
| Cohort 2 With 1 Unit of CPP | Corrected Count Increments (CCI) | CII: Day 2 | -2.05 mm^2/(μL*1011 platelets) | Standard Deviation 4.96 |
| Cohort 3 With 2 Units of CPP | Corrected Count Increments (CCI) | CII: Day 1 up to 6 hrs after | 2.73 mm^2/(μL*1011 platelets) | Standard Deviation 1.51 |
| Cohort 3 With 2 Units of CPP | Corrected Count Increments (CCI) | CII: Day 2 | 5.63 mm^2/(μL*1011 platelets) | Standard Deviation 7.05 |
| Cohort 4 With 3 Units of CPP | Corrected Count Increments (CCI) | CII: Day 2 | 2.35 mm^2/(μL*1011 platelets) | Standard Deviation 3.94 |
| Cohort 4 With 3 Units of CPP | Corrected Count Increments (CCI) | CII: Day 1 up to 6 hrs after | 3.70 mm^2/(μL*1011 platelets) | Standard Deviation 2.34 |
| 1 Unit of LSP | Corrected Count Increments (CCI) | CII: Day 1 up to 6 hrs after | 14.8 mm^2/(μL*1011 platelets) | Standard Deviation 9.66 |
| 1 Unit of LSP | Corrected Count Increments (CCI) | CII: Day 2 | 4.13 mm^2/(μL*1011 platelets) | Standard Deviation 3.58 |
Other Pre-specified
Count Increment
Count Increment expressed in units of platelets (x10\^3 µL) (CI)
Time frame: On Day 1 up to 6 hours after transfusion and on Day 2 approximately 24 hours after transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 With 0.5 Units of CPP | Count Increment | Day 1 Up to 6 Hours After | 1.20 platelets*10^3 µL | Standard Deviation 3.11 |
| Cohort 1 With 0.5 Units of CPP | Count Increment | Day 2 | 2.80 platelets*10^3 µL | Standard Deviation 3.11 |
| Cohort 2 With 1 Unit of CPP | Count Increment | Day 2 | -2.57 platelets*10^3 µL | Standard Deviation 6.4 |
| Cohort 2 With 1 Unit of CPP | Count Increment | Day 1 Up to 6 Hours After | 3.67 platelets*10^3 µL | Standard Deviation 2.42 |
| Cohort 3 With 2 Units of CPP | Count Increment | Day 1 Up to 6 Hours After | 6.50 platelets*10^3 µL | Standard Deviation 3.89 |
| Cohort 3 With 2 Units of CPP | Count Increment | Day 2 | 12.5 platelets*10^3 µL | Standard Deviation 14.2 |
| Cohort 4 With 3 Units of CPP | Count Increment | Day 2 | 10.7 platelets*10^3 µL | Standard Deviation 13.3 |
| Cohort 4 With 3 Units of CPP | Count Increment | Day 1 Up to 6 Hours After | 13.2 platelets*10^3 µL | Standard Deviation 6.38 |
| 1 Unit of LSP | Count Increment | Day 2 | 8.75 platelets*10^3 µL | Standard Deviation 7.97 |
| 1 Unit of LSP | Count Increment | Day 1 Up to 6 Hours After | 30.5 platelets*10^3 µL | Standard Deviation 20.3 |