Mirasol Evaluation of Reduction in Infections Trial (NCT03737669) | Clinical Trial Compass
CompletedPhase 3
Mirasol Evaluation of Reduction in Infections Trial
Uganda2,000 participantsStarted 2019-11-13
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative incidence of at least one (1) pre-defined TTI