Evaluating Mirasol-treated blood for reducing infections in transfusions
Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Emerging Transfusion Transmitted Infections
This study is testing if blood treated with a special method called Mirasol can help prevent infections in anemic patients receiving blood transfusions at a hospital in Uganda.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Kampala) |
| Trial ID | NCT03737669 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, randomized, double-blind, controlled study aimed at assessing the effectiveness of Mirasol-treated fresh whole blood (FWB) compared to standard-issue FWB in preventing transfusion-transmitted infections (TTIs). Anemic patients requiring blood transfusions at Mulago Hospital Complex in Uganda will be recruited and randomly assigned to receive either Mirasol-treated or standard FWB. The study will monitor the incidence of various TTIs through laboratory assessments at multiple time points over a 10-week follow-up period. The trial aims to provide insights into the safety and efficacy of pathogen reduction technology in blood transfusions.
Who should consider this trial
Good fit: Ideal candidates for this study are anemic patients with hemoglobin levels below 7 g/dL who require fresh whole blood transfusions due to conditions like cancer, surgical needs, obstetric hemorrhage, or sickle cell disease.
Not a fit: Patients who are HIV-infected, have red cell alloantibodies, or are expected to require additional blood products outside of the trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of infections transmitted through blood transfusions, improving patient safety.
How similar studies have performed: Other studies have shown promise with similar pathogen reduction technologies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kampala
- Mulago Hospital Complex — Kampala, Uganda (Recruiting)
Study contacts
- Principal investigator: Aaron Tobian, MD, PhD — Johns Hopkins University
- Study coordinator: Ruchee Shrestha, MPH
- Email: ruchee@jhu.edu
- Phone: 410-614-1902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.