N/A
Completed N=227
Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria
Source: ClinicalTrials.gov NCT02118428 ↗Enrolled (actual)
227
Serious AEs
9.9%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants With Incidence of Transfusion-transmitted Malaria — 3.6; 21.6 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Incidence of Transfusion-transmitted Malaria |
3.6; 21.6 | — |
| SECONDARY Bacterial Contamination of Fresh Whole Blood (FWB) Products |
3.3; 3.2; 6.6; NA | — |
| SECONDARY Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit |
38.14; 38.10; 35.54; 37.66 | — |
| SECONDARY Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin |
12.98; 12.93; 11.97; 12.74 | — |
| SECONDARY Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count |
4.58; 4.57; 4.20; 4.47 | — |
| SECONDARY Hematology Parameter in Fresh Whole Blood Products - Platelet Count |
156.2; 156.9; 85.3; 101.3 | — |
| SECONDARY Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count |
4.32; 4.45; 3.69; 3.74 | — |
| SECONDARY Biochemistry Parameter in Fresh Whole Blood Products - Potassium |
3.61; 3.85; 14.97; 7.16 | — |
| SECONDARY Hematology Parameter in Patients - Hematocrit |
19.69; 19.52; 24.25; 24.08; 24.50; 25.48 | — |
| SECONDARY Hematology Parameter in Patients - Total Hemoglobin |
6.71; 6.71; 8.53; 8.49; 8.49; 8.83 | — |
| SECONDARY Hematology Parameter in Patients - Platelet Count |
238.0; 234.50; 202.40; 206.0; 229.30; 228.20 | — |
| SECONDARY Hematology Parameter in Patients - Red Blood Cell (RBC) Count |
2.51; 2.52; 3.05; 3.02; 3.12; 3.27 | — |
| SECONDARY Hematology Parameter in Patients - White Blood Cell (WBC) Count |
10.34; 9.94; 8.71; 8.07; 7.91; 7.54 | — |
| SECONDARY Biochemistry Parameter in Patients - Potassium |
4.12; 4.17; 4.14; 3.80; 3.90; 3.97 | — |
| SECONDARY Coagulation Parameter in Patients - Prothrombin Time |
10.08; 10.07; 10.19; 9.71; 9.36; 9.62 | — |
| SECONDARY Coagulation Parameter in Patients - Activated Partial Thromboplastin Time |
29.61; 29.12; 29.89; 29.0; 28.54; 27.89 | — |
| SECONDARY Coagulation Parameter in Patients - International Normalized Ratio (INR) |
1.05; 1.04; 1.07; 1.02; 0.99; 1.01 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02118428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.