- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03737669
Mirasol Evaluation of Reduction in Infections Trial (MERIT)
Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Emerging Transfusion Transmitted Infections
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Anemic patients from Mulago Hospital Complex who require fresh whole blood transfusion and with any of the following conditions will be considered for recruitment: cancer, general medical or surgical, obstetric hemorrhage, and/or sickle cell. Eligible patients will be randomized 1:1 to receive transfusions of Mirasol-treated FWB (n = 1,000) or standard issue FWB (n = 1,000) during the 10 week follow-up interval. The Ugandan Blood Transfusion Service collects and screens donor blood and will provide both Standard and Mirasol-treated blood for transfusion. Currently, all standard FWB is non-leukoreduced and tested by serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) and by rapid plasma regain (RPR) for syphilis in Uganda; any units that test positive are discarded. The intervention will treat standard FWB that has been screened for HIV, HBV, HCV, and syphilis with Mirasol PRT.
The start of study treatment (Day 0) will be defined as the initiation of the first FWB transfusion. Recipient blood collected at pre-transfusion, Day 2, Day 7, Week 4, and Week 10 will be compared with donor blood to evaluate for incidence of pre-defined TTIs: bacteria, HBV, HCV, hepatitis E virus (HEV), human herpesvirus-8 (HHV8), HIV, and malaria. Recipients will be evaluated for possible transfusion reactions at those timepoints, as well as 2 to 6 hours after the first transfusion.
The primary objective of the Uganda Mirasol Trial is to evaluate the efficacy of Mirasol-treated FWB to prevent transfusion transmission of emerging infectious diseases. The secondary objectives are to evaluate the impact of TTIs in Uganda and potential for Mirasol PRT, as well as to assess the feasibility and sustainability of implementing whole blood Mirasol pathogen reduction technology (PRT) in austere settings.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Ruchee Shrestha, MPH
- Phone Number: 410-614-1902
- Email: ruchee@jhu.edu
Study Contact Backup
- Name: Amber Bassett
- Email: abassett1@jhmi.edu
Study Locations
-
-
-
Kampala, Uganda
- Recruiting
- Mulago Hospital Complex
-
Contact:
- Monica Nolan, MD, MPH
- Phone Number: 204 +256 (414) 541-044
- Email: mnolan@mujhu.org
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Contact:
- Irene Lubega, MD
- Email: ilubrga@mujhu.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mirasol-treated Fresh Whole Blood
Standard Fresh Whole Blood, treated with Mirasol Pathogen Reduction Technology
|
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.
|
Placebo Comparator: Standard Fresh Whole Blood
Standard-issue fresh whole blood
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative incidence of at least one (1) pre-defined TTI
Time Frame: Up to 10 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aaron Tobian, MD, PhD, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00174892
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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