Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03737669 | Mirasol Evaluation of Reduction in Infections Trial | PHASE3 | COMPLETED | 2,000 | — | — | Nov 13, 2019 | Sep 29, 2025 | Oct 6, 2025 | 1 | Uganda |
New case of any pre-defined TTIs (HIV, HBV, HCV, HEV, HHV-8, malaria, and/or bacterial infection) in a previously negative patient and matched from the blood donor, indicated by changes in laboratory findings at Day 2, Day 7, Week 4, or Week 10 after the first transfusion.
| Arm | Type | Description |
|---|---|---|
| Mirasol-treated Fresh Whole Blood | EXPERIMENTAL | Standard Fresh Whole Blood, treated with Mirasol Pathogen Reduction Technology |
| Standard Fresh Whole Blood | PLACEBO_COMPARATOR | Standard-issue fresh whole blood |
| Name | Type | Description |
|---|---|---|
| Mirasol-treated Fresh Whole Blood | BIOLOGICAL | Standard issue FWB, which gave negative serological assay results for HIV, HBV, HCV, and syphilis will subsequently be treated with Mirasol PRT, then stored at 1 - 6 degrees Celsius and transfused within 21 days of collection. |
| Standard Fresh Whole Blood | BIOLOGICAL | Fresh whole blood that gave negative serological assay results for HIV, HBV, HCV, and syphilis will be stored at 1 - 6 degrees Celsius and transfused within 21 days of collection. |
Inclusion Criteria: * Willing to participate in study and patient or legally authorized representative has given written informed consent (IC) * Hemoglobin \< 7 g/dL or decision to transfusion by clinical team * Transfusion necessary based on clinical judgment of attending physician * Agree to retu...