Transfusion-Transmitted Infectious Disease Clinical Trial
— MERITOfficial title:
Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Emerging Transfusion Transmitted Infections
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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | October 7, 2025 |
Est. primary completion date | October 7, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Uganda | Mulago Hospital Complex | Kampala |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | MU-JHU CARE, Terumo BCT, United States Department of Defense |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative incidence of at least one (1) pre-defined TTI | 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. | Up to 10 weeks |