Malaria
Conditions
Keywords
whole blood, transfusion, Plasmodium, Malaria, Pathogen Reduction Technology, Whole blood transfusion
Brief summary
The trial will evaluate the efficacy of the Mirasol Pathogen Reduction Technology for Whole Blood to prevent Malaria transmission by transfusion of whole blood.
Interventions
DEVICEMirasol-treated Whole Blood
Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
BIOLOGICALUntreated Whole Blood
Transfusion with untreated fresh Whole Blood
Sponsors
Terumo BCTbio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Patient is blood group O+ * Anticipated to be hospitalized for at least 3 consecutive days after initial study transfusion * Expected to require no more than 2 units of Fresh Whole Blood in the 3 days following randomization * Agree to return to the hospital for the follow-up visits * Women of Child Bearing Potential must have a negative pregnancy test within 72 hours before randomization when warranted and must agree to practice a medically acceptable contraception regimen or agree to abstain from heterosexual intercourse during their study participation. * Patient or legally authorized representative has given written informed consent
Exclusion criteria
* Symptoms of clinical malaria (confirmed by microscopy) * Patient has received antimalarial treatment within 7 days prior to randomization * Fever (Central body temperature greater than 38.5°C) * Massive bleeding expected to require more than two Fresh Whole Blood units within 3 days from randomization * Transfusion(s) of a blood product within 1 month prior to randomization * Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the patient to receive protocol treatment * Previous treatment with other pathogen-reduced blood products * Females who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Incidence of Transfusion-transmitted Malaria | Up to 28 (+4) days after the initial whole blood transfusion (measured within 24 hours prior to each transfusion and at 24 (± 4) hours, 2 days, 3 days, 7 (+1) days, and 28 (+4) days after the initial whole blood transfusion) | Percentage of Participants who contracted transfusion-transmitted malaria (TTM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) | Hematocrit measurement in FWB products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. |
| Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) | Total hemoglobin measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. |
| Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) | RBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. |
| Hematology Parameter in Fresh Whole Blood Products - Platelet Count | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) | Platelet count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. |
| Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) | WBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. |
| Biochemistry Parameter in Fresh Whole Blood Products - Potassium | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) | Potassium measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. |
| Hematology Parameter in Patients - Hematocrit | Days 0, 1, 2, 3, 7, 28 | Hematocrit measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. |
| Bacterial Contamination of Fresh Whole Blood (FWB) Products | immediately post-blood product collection & within 7 days before transfusion, post-Mirasol treatment (within 24 hours post-blood product collection) & within 7 days before transfusion | Bacterial culture on blood products - products were collected within 7 days before transfusion to the study subject. Control products were only sampled post-collection, so no results for post-Mirasol treatment. All samples in Mirasol group that were positive post-collection became negative post-Mirasol treatment. All samples in Mirasol group that were positive post-Mirasol treatment were negative post-collection. These samples were likely contaminated in the clinical laboratory after Mirasol treatment during sampling for culture. |
| Hematology Parameter in Patients - Platelet Count | Days 0, 1, 2, 3, 7, 28 | Platelet count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. |
| Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Days 0, 1, 2, 3, 7, 28 | RBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. |
| Hematology Parameter in Patients - White Blood Cell (WBC) Count | Days 0, 1, 2, 3, 7, 28 | WBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. |
| Biochemistry Parameter in Patients - Potassium | Days 0, 1, 2, 3 | Potassium measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. |
| Coagulation Parameter in Patients - Prothrombin Time | Days 0, 1, 2, 3 | Prothrombin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. |
| Coagulation Parameter in Patients - Activated Partial Thromboplastin Time | Days 0, 1, 2, 3 | Activated partial thromboplastin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. |
| Coagulation Parameter in Patients - International Normalized Ratio (INR) | Days 0, 1, 2, 3 | INR measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. |
| Hematology Parameter in Patients - Total Hemoglobin | Days 0, 1, 2, 3, 7, 28 | Total hemoglobin measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. |
Countries
Ghana
Participant flow
Pre-assignment details
227 total were enrolled, but one participant was ineligible prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Mirasol Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood | 111 |
| Control Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood | 112 |
| Total | 223 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 7 | 5 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Screen Failure or Became Inelegible | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Mirasol | Control | Total |
|---|---|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 15.3 | 40.7 years STANDARD_DEVIATION 17 | 39.8 years STANDARD_DEVIATION 16.2 |
| Age, Customized 18-39 years | 62 Participants | 67 Participants | 129 Participants |
| Age, Customized 40-59 years | 35 Participants | 28 Participants | 63 Participants |
| Age, Customized >=60 years | 14 Participants | 17 Participants | 31 Participants |
| Body Mass Index | 24.0 kilogram/meter² STANDARD_DEVIATION 4.9 | 24.2 kilogram/meter² STANDARD_DEVIATION 4.4 | 24.1 kilogram/meter² STANDARD_DEVIATION 4.6 |
| Height | 1.62 meter STANDARD_DEVIATION 0.08 | 1.63 meter STANDARD_DEVIATION 0.07 | 1.62 meter STANDARD_DEVIATION 0.08 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 111 Participants | 112 Participants | 223 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 77 Participants | 84 Participants | 161 Participants |
| Sex: Female, Male Male | 34 Participants | 28 Participants | 62 Participants |
| Weight | 62.7 kilogram STANDARD_DEVIATION 13.4 | 63.9 kilogram STANDARD_DEVIATION 12 | 63.3 kilogram STANDARD_DEVIATION 12.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 111 | 37 / 112 |
| serious Total, serious adverse events | 13 / 111 | 9 / 112 |
Outcome results
Primary
Percentage of Participants With Incidence of Transfusion-transmitted Malaria
Percentage of Participants who contracted transfusion-transmitted malaria (TTM)
Time frame: Up to 28 (+4) days after the initial whole blood transfusion (measured within 24 hours prior to each transfusion and at 24 (± 4) hours, 2 days, 3 days, 7 (+1) days, and 28 (+4) days after the initial whole blood transfusion)
Population: Evaluable population = randomized subjects who received up to 2 whole blood transfusions and no non-study blood products, who did not receive any anti-malarial treatment, who had no significant protocol deviations and who additionally were non parasitemic pre-transfusion and received at least one parasitemic fresh whole blood product
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirasol | Percentage of Participants With Incidence of Transfusion-transmitted Malaria | 3.6 Percentage of participants |
| Control | Percentage of Participants With Incidence of Transfusion-transmitted Malaria | 21.6 Percentage of participants |
Secondary
Bacterial Contamination of Fresh Whole Blood (FWB) Products
Bacterial culture on blood products - products were collected within 7 days before transfusion to the study subject. Control products were only sampled post-collection, so no results for post-Mirasol treatment. All samples in Mirasol group that were positive post-collection became negative post-Mirasol treatment. All samples in Mirasol group that were positive post-Mirasol treatment were negative post-collection. These samples were likely contaminated in the clinical laboratory after Mirasol treatment during sampling for culture.
Time frame: immediately post-blood product collection & within 7 days before transfusion, post-Mirasol treatment (within 24 hours post-blood product collection) & within 7 days before transfusion
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirasol | Bacterial Contamination of Fresh Whole Blood (FWB) Products | Positive post-collection | 3.3 percentage of blood product samples |
| Mirasol | Bacterial Contamination of Fresh Whole Blood (FWB) Products | Positive post-Mirasol treatment | 6.6 percentage of blood product samples |
| Control | Bacterial Contamination of Fresh Whole Blood (FWB) Products | Positive post-collection | 3.2 percentage of blood product samples |
| Control | Bacterial Contamination of Fresh Whole Blood (FWB) Products | Positive post-Mirasol treatment | NA percentage of blood product samples |
Secondary
Biochemistry Parameter in Fresh Whole Blood Products - Potassium
Potassium measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.
Time frame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Biochemistry Parameter in Fresh Whole Blood Products - Potassium | Potassium, post-collection | 3.61 mmol/L | Standard Deviation 2.55 |
| Mirasol | Biochemistry Parameter in Fresh Whole Blood Products - Potassium | Potassium, prior to transfusion | 14.97 mmol/L | Standard Deviation 7.71 |
| Control | Biochemistry Parameter in Fresh Whole Blood Products - Potassium | Potassium, prior to transfusion | 7.16 mmol/L | Standard Deviation 3.27 |
| Control | Biochemistry Parameter in Fresh Whole Blood Products - Potassium | Potassium, post-collection | 3.85 mmol/L | Standard Deviation 3.33 |
Secondary
Biochemistry Parameter in Patients - Potassium
Potassium measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Time frame: Days 0, 1, 2, 3
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Biochemistry Parameter in Patients - Potassium | Day 0 | 4.12 mmol/L | Standard Deviation 0.85 |
| Mirasol | Biochemistry Parameter in Patients - Potassium | Day 1 | 4.14 mmol/L | Standard Deviation 0.75 |
| Mirasol | Biochemistry Parameter in Patients - Potassium | Day 2 | 3.90 mmol/L | Standard Deviation 0.69 |
| Mirasol | Biochemistry Parameter in Patients - Potassium | Day 3 | 4.00 mmol/L | Standard Deviation 0.69 |
| Control | Biochemistry Parameter in Patients - Potassium | Day 3 | 3.93 mmol/L | Standard Deviation 0.61 |
| Control | Biochemistry Parameter in Patients - Potassium | Day 0 | 4.17 mmol/L | Standard Deviation 0.8 |
| Control | Biochemistry Parameter in Patients - Potassium | Day 2 | 3.97 mmol/L | Standard Deviation 0.63 |
| Control | Biochemistry Parameter in Patients - Potassium | Day 1 | 3.80 mmol/L | Standard Deviation 0.49 |
Secondary
Coagulation Parameter in Patients - Activated Partial Thromboplastin Time
Activated partial thromboplastin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Time frame: Days 0, 1, 2, 3
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Coagulation Parameter in Patients - Activated Partial Thromboplastin Time | Day 0 | 29.61 seconds | Standard Deviation 9.12 |
| Mirasol | Coagulation Parameter in Patients - Activated Partial Thromboplastin Time | Day 1 | 29.89 seconds | Standard Deviation 7.47 |
| Mirasol | Coagulation Parameter in Patients - Activated Partial Thromboplastin Time | Day 2 | 28.54 seconds | Standard Deviation 6.64 |
| Mirasol | Coagulation Parameter in Patients - Activated Partial Thromboplastin Time | Day 3 | 28.60 seconds | Standard Deviation 6.33 |
| Control | Coagulation Parameter in Patients - Activated Partial Thromboplastin Time | Day 3 | 29.68 seconds | Standard Deviation 7.73 |
| Control | Coagulation Parameter in Patients - Activated Partial Thromboplastin Time | Day 0 | 29.12 seconds | Standard Deviation 9.47 |
| Control | Coagulation Parameter in Patients - Activated Partial Thromboplastin Time | Day 2 | 27.89 seconds | Standard Deviation 6.45 |
| Control | Coagulation Parameter in Patients - Activated Partial Thromboplastin Time | Day 1 | 29.0 seconds | Standard Deviation 10.25 |
Secondary
Coagulation Parameter in Patients - International Normalized Ratio (INR)
INR measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Time frame: Days 0, 1, 2, 3
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Coagulation Parameter in Patients - International Normalized Ratio (INR) | Day 0 | 1.05 ratio | Standard Deviation 0.26 |
| Mirasol | Coagulation Parameter in Patients - International Normalized Ratio (INR) | Day 1 | 1.07 ratio | Standard Deviation 0.25 |
| Mirasol | Coagulation Parameter in Patients - International Normalized Ratio (INR) | Day 2 | 0.99 ratio | Standard Deviation 0.19 |
| Mirasol | Coagulation Parameter in Patients - International Normalized Ratio (INR) | Day 3 | 1.00 ratio | Standard Deviation 0.19 |
| Control | Coagulation Parameter in Patients - International Normalized Ratio (INR) | Day 3 | 1.04 ratio | Standard Deviation 0.25 |
| Control | Coagulation Parameter in Patients - International Normalized Ratio (INR) | Day 0 | 1.04 ratio | Standard Deviation 0.33 |
| Control | Coagulation Parameter in Patients - International Normalized Ratio (INR) | Day 2 | 1.01 ratio | Standard Deviation 0.2 |
| Control | Coagulation Parameter in Patients - International Normalized Ratio (INR) | Day 1 | 1.02 ratio | Standard Deviation 0.27 |
Secondary
Coagulation Parameter in Patients - Prothrombin Time
Prothrombin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Time frame: Days 0, 1, 2, 3
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Coagulation Parameter in Patients - Prothrombin Time | Day 0 | 10.08 seconds | Standard Deviation 3.11 |
| Mirasol | Coagulation Parameter in Patients - Prothrombin Time | Day 1 | 10.19 seconds | Standard Deviation 2.86 |
| Mirasol | Coagulation Parameter in Patients - Prothrombin Time | Day 2 | 9.36 seconds | Standard Deviation 2.2 |
| Mirasol | Coagulation Parameter in Patients - Prothrombin Time | Day 3 | 9.53 seconds | Standard Deviation 2.28 |
| Control | Coagulation Parameter in Patients - Prothrombin Time | Day 3 | 9.97 seconds | Standard Deviation 3.03 |
| Control | Coagulation Parameter in Patients - Prothrombin Time | Day 0 | 10.07 seconds | Standard Deviation 4.02 |
| Control | Coagulation Parameter in Patients - Prothrombin Time | Day 2 | 9.62 seconds | Standard Deviation 2.48 |
| Control | Coagulation Parameter in Patients - Prothrombin Time | Day 1 | 9.71 seconds | Standard Deviation 3.33 |
Secondary
Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit
Hematocrit measurement in FWB products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.
Time frame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit | Hematocrit, post-collection | 38.14 percentage | Standard Deviation 3.2 |
| Mirasol | Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit | Hematocrit, prior to transfusion | 35.54 percentage | Standard Deviation 2.81 |
| Control | Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit | Hematocrit, post-collection | 38.10 percentage | Standard Deviation 3.03 |
| Control | Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit | Hematocrit, prior to transfusion | 37.66 percentage | Standard Deviation 2.77 |
Secondary
Hematology Parameter in Fresh Whole Blood Products - Platelet Count
Platelet count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.
Time frame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Hematology Parameter in Fresh Whole Blood Products - Platelet Count | Platelet count, post-collection | 156.2 Cells x 10e9/L | Standard Deviation 44.3 |
| Mirasol | Hematology Parameter in Fresh Whole Blood Products - Platelet Count | Platelet count, prior to transfusion | 85.3 Cells x 10e9/L | Standard Deviation 37.9 |
| Control | Hematology Parameter in Fresh Whole Blood Products - Platelet Count | Platelet count, post-collection | 156.9 Cells x 10e9/L | Standard Deviation 46.2 |
| Control | Hematology Parameter in Fresh Whole Blood Products - Platelet Count | Platelet count, prior to transfusion | 101.3 Cells x 10e9/L | Standard Deviation 57.2 |
Secondary
Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count
RBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.
Time frame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count | RBC count, post-collection | 4.58 Cells x 10e12/L | Standard Deviation 0.49 |
| Mirasol | Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count | RBC count, prior to transfusion | 4.20 Cells x 10e12/L | Standard Deviation 0.49 |
| Control | Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count | RBC count, post-collection | 4.57 Cells x 10e12/L | Standard Deviation 0.52 |
| Control | Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count | RBC count, prior to transfusion | 4.47 Cells x 10e12/L | Standard Deviation 0.47 |
Secondary
Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin
Total hemoglobin measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.
Time frame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin | Total hemoglobin, post-collection | 12.98 g/dL | Standard Deviation 1.18 |
| Mirasol | Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin | Total hemoglobin, prior to transfusion | 11.97 g/dL | Standard Deviation 0.98 |
| Control | Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin | Total hemoglobin, post-collection | 12.93 g/dL | Standard Deviation 1.13 |
| Control | Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin | Total hemoglobin, prior to transfusion | 12.74 g/dL | Standard Deviation 1.03 |
Secondary
Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count
WBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.
Time frame: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count | WBC, post-collection | 4.32 Cells x 10e9/L | Standard Deviation 1.05 |
| Mirasol | Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count | WBC, prior to transfusion | 3.69 Cells x 10e9/L | Standard Deviation 1.08 |
| Control | Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count | WBC, post-collection | 4.45 Cells x 10e9/L | Standard Deviation 1.16 |
| Control | Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count | WBC, prior to transfusion | 3.74 Cells x 10e9/L | Standard Deviation 1.39 |
Secondary
Hematology Parameter in Patients - Hematocrit
Hematocrit measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Time frame: Days 0, 1, 2, 3, 7, 28
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Hematology Parameter in Patients - Hematocrit | Day 1 | 24.25 percentage | Standard Deviation 5.47 |
| Mirasol | Hematology Parameter in Patients - Hematocrit | Day 3 | 24.72 percentage | Standard Deviation 4.7 |
| Mirasol | Hematology Parameter in Patients - Hematocrit | Day 7 | 26.62 percentage | Standard Deviation 4.88 |
| Mirasol | Hematology Parameter in Patients - Hematocrit | Day 0 | 19.69 percentage | Standard Deviation 5.4 |
| Mirasol | Hematology Parameter in Patients - Hematocrit | Day 28 | 28.61 percentage | Standard Deviation 6.2 |
| Mirasol | Hematology Parameter in Patients - Hematocrit | Day 2 | 24.50 percentage | Standard Deviation 4.48 |
| Control | Hematology Parameter in Patients - Hematocrit | Day 28 | 29.68 percentage | Standard Deviation 5.56 |
| Control | Hematology Parameter in Patients - Hematocrit | Day 0 | 19.52 percentage | Standard Deviation 5.01 |
| Control | Hematology Parameter in Patients - Hematocrit | Day 1 | 24.08 percentage | Standard Deviation 4.21 |
| Control | Hematology Parameter in Patients - Hematocrit | Day 2 | 25.48 percentage | Standard Deviation 4.76 |
| Control | Hematology Parameter in Patients - Hematocrit | Day 7 | 26.92 percentage | Standard Deviation 4.62 |
| Control | Hematology Parameter in Patients - Hematocrit | Day 3 | 25.68 percentage | Standard Deviation 4.77 |
Secondary
Hematology Parameter in Patients - Platelet Count
Platelet count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Time frame: Days 0, 1, 2, 3, 7, 28
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Hematology Parameter in Patients - Platelet Count | Day 0 | 238.0 Cells x 10e9/L | Standard Deviation 168.79 |
| Mirasol | Hematology Parameter in Patients - Platelet Count | Day 1 | 202.40 Cells x 10e9/L | Standard Deviation 155.85 |
| Mirasol | Hematology Parameter in Patients - Platelet Count | Day 2 | 229.30 Cells x 10e9/L | Standard Deviation 145.56 |
| Mirasol | Hematology Parameter in Patients - Platelet Count | Day 3 | 235.50 Cells x 10e9/L | Standard Deviation 139.11 |
| Mirasol | Hematology Parameter in Patients - Platelet Count | Day 7 | 324.40 Cells x 10e9/L | Standard Deviation 152.79 |
| Mirasol | Hematology Parameter in Patients - Platelet Count | Day 28 | 269.10 Cells x 10e9/L | Standard Deviation 115.21 |
| Control | Hematology Parameter in Patients - Platelet Count | Day 7 | 332.40 Cells x 10e9/L | Standard Deviation 156.16 |
| Control | Hematology Parameter in Patients - Platelet Count | Day 0 | 234.50 Cells x 10e9/L | Standard Deviation 147.03 |
| Control | Hematology Parameter in Patients - Platelet Count | Day 3 | 235.70 Cells x 10e9/L | Standard Deviation 124.79 |
| Control | Hematology Parameter in Patients - Platelet Count | Day 1 | 206.0 Cells x 10e9/L | Standard Deviation 121.47 |
| Control | Hematology Parameter in Patients - Platelet Count | Day 28 | 271.50 Cells x 10e9/L | Standard Deviation 126.15 |
| Control | Hematology Parameter in Patients - Platelet Count | Day 2 | 228.20 Cells x 10e9/L | Standard Deviation 132.68 |
Secondary
Hematology Parameter in Patients - Red Blood Cell (RBC) Count
RBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Time frame: Days 0, 1, 2, 3, 7, 28
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Day 0 | 2.51 Cells x 10e12/L | Standard Deviation 0.75 |
| Mirasol | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Day 1 | 3.05 Cells x 10e12/L | Standard Deviation 0.75 |
| Mirasol | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Day 2 | 3.12 Cells x 10e12/L | Standard Deviation 0.66 |
| Mirasol | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Day 3 | 3.15 Cells x 10e12/L | Standard Deviation 0.7 |
| Mirasol | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Day 7 | 3.35 Cells x 10e12/L | Standard Deviation 0.7 |
| Mirasol | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Day 28 | 3.60 Cells x 10e12/L | Standard Deviation 0.84 |
| Control | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Day 7 | 3.41 Cells x 10e12/L | Standard Deviation 0.68 |
| Control | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Day 0 | 2.52 Cells x 10e12/L | Standard Deviation 0.72 |
| Control | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Day 3 | 3.30 Cells x 10e12/L | Standard Deviation 0.73 |
| Control | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Day 1 | 3.02 Cells x 10e12/L | Standard Deviation 0.6 |
| Control | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Day 28 | 3.75 Cells x 10e12/L | Standard Deviation 0.72 |
| Control | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | Day 2 | 3.27 Cells x 10e12/L | Standard Deviation 0.71 |
Secondary
Hematology Parameter in Patients - Total Hemoglobin
Total hemoglobin measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Time frame: Days 0, 1, 2, 3, 7, 28
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Hematology Parameter in Patients - Total Hemoglobin | Day 0 | 6.71 g/dL | Standard Deviation 1.97 |
| Mirasol | Hematology Parameter in Patients - Total Hemoglobin | Day 1 | 8.53 g/dL | Standard Deviation 2.02 |
| Mirasol | Hematology Parameter in Patients - Total Hemoglobin | Day 2 | 8.49 g/dL | Standard Deviation 1.58 |
| Mirasol | Hematology Parameter in Patients - Total Hemoglobin | Day 3 | 8.57 g/dL | Standard Deviation 1.58 |
| Mirasol | Hematology Parameter in Patients - Total Hemoglobin | Day 7 | 9.07 g/dL | Standard Deviation 1.75 |
| Mirasol | Hematology Parameter in Patients - Total Hemoglobin | Day 28 | 9.72 g/dL | Standard Deviation 2.17 |
| Control | Hematology Parameter in Patients - Total Hemoglobin | Day 7 | 9.18 g/dL | Standard Deviation 1.6 |
| Control | Hematology Parameter in Patients - Total Hemoglobin | Day 0 | 6.71 g/dL | Standard Deviation 1.79 |
| Control | Hematology Parameter in Patients - Total Hemoglobin | Day 3 | 8.91 g/dL | Standard Deviation 1.65 |
| Control | Hematology Parameter in Patients - Total Hemoglobin | Day 1 | 8.49 g/dL | Standard Deviation 1.55 |
| Control | Hematology Parameter in Patients - Total Hemoglobin | Day 28 | 10.14 g/dL | Standard Deviation 1.9 |
| Control | Hematology Parameter in Patients - Total Hemoglobin | Day 2 | 8.83 g/dL | Standard Deviation 1.64 |
Secondary
Hematology Parameter in Patients - White Blood Cell (WBC) Count
WBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Time frame: Days 0, 1, 2, 3, 7, 28
Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol | Hematology Parameter in Patients - White Blood Cell (WBC) Count | Day 0 | 10.34 Cells x 10e9/L | Standard Deviation 10.01 |
| Mirasol | Hematology Parameter in Patients - White Blood Cell (WBC) Count | Day 1 | 8.71 Cells x 10e9/L | Standard Deviation 5.64 |
| Mirasol | Hematology Parameter in Patients - White Blood Cell (WBC) Count | Day 2 | 7.91 Cells x 10e9/L | Standard Deviation 7.11 |
| Mirasol | Hematology Parameter in Patients - White Blood Cell (WBC) Count | Day 3 | 7.42 Cells x 10e9/L | Standard Deviation 6.42 |
| Mirasol | Hematology Parameter in Patients - White Blood Cell (WBC) Count | Day 7 | 7.15 Cells x 10e9/L | Standard Deviation 7.22 |
| Mirasol | Hematology Parameter in Patients - White Blood Cell (WBC) Count | Day 28 | 5.88 Cells x 10e9/L | Standard Deviation 5 |
| Control | Hematology Parameter in Patients - White Blood Cell (WBC) Count | Day 7 | 7.22 Cells x 10e9/L | Standard Deviation 4.96 |
| Control | Hematology Parameter in Patients - White Blood Cell (WBC) Count | Day 0 | 9.94 Cells x 10e9/L | Standard Deviation 6.97 |
| Control | Hematology Parameter in Patients - White Blood Cell (WBC) Count | Day 3 | 7.09 Cells x 10e9/L | Standard Deviation 4.99 |
| Control | Hematology Parameter in Patients - White Blood Cell (WBC) Count | Day 1 | 8.07 Cells x 10e9/L | Standard Deviation 4.02 |
| Control | Hematology Parameter in Patients - White Blood Cell (WBC) Count | Day 28 | 5.48 Cells x 10e9/L | Standard Deviation 2.95 |
| Control | Hematology Parameter in Patients - White Blood Cell (WBC) Count | Day 2 | 7.54 Cells x 10e9/L | Standard Deviation 4.8 |