Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Emerging Transfusion Transmitted Infections

IRB00174892

This is a prospective, randomized, double-blind, controlled study to determine the effectiveness of Mirasol-treated fresh whole blood (FWB) versus Standard-issue FWB for preventing transmission of transfusion-transmitted infections (TTIs). The incidence of pre-defined viral, bacterial, or parasitic TTIs in previously negative participants will be assessed by changes in laboratory findings at multiple time points over the course of the clinical trial.

2019-11-13

2025-10-07

2025-10-07

Recruiting

Early phase I

2000

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 return to the hospital for the follow-up visits Exclusion Criteria: * Presence of red cell alloantibodies * Incompatible red cell crossmatch * Not expected to survive for 10 weeks * Expected to require plasma or platelets within next 10 weeks outside of the FWB provided in the trial * Blood type AB (due to concern of limited supply) * Weight \< 30 kg (due to concern for sufficient blood draws to detect bacteria and other TTIs) * HIV-infected * Clinical suspicion of sepsis * Anti-malarial treatment within 7 days prior to randomization * Fever (central body temperature greater than 38.5°C) * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2000, 'type': 'ESTIMATED'}}

2023-10-10