Mirasol Evaluation of Reduction in Infections Trial (MERIT)
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|ClinicalTrials.gov Identifier: NCT03737669|
Recruitment Status : Not yet recruiting
First Posted : November 9, 2018
Last Update Posted : April 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Transfusion-Transmitted Infectious Disease||Biological: Mirasol-treated Fresh Whole Blood Biological: Standard Fresh Whole Blood||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Emerging Transfusion Transmitted Infections|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||October 7, 2021|
|Estimated Study Completion Date :||October 7, 2021|
Experimental: Mirasol-treated Fresh Whole Blood
Standard Fresh Whole Blood, treated with Mirasol Pathogen Reduction Technology
Biological: Mirasol-treated Fresh Whole Blood
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
Biological: Standard 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737669
|Contact: Ruchee Shrestha, MPHfirstname.lastname@example.org|
|Contact: Amber Bassettemail@example.com|
|Mulago Hospital Complex||Not yet recruiting|
|Contact: Monica Nolan, MD, MPH +256 (414) 541-044 ext 204 firstname.lastname@example.org|
|Contact: Irene Lubega, MD email@example.com|
|Principal Investigator:||Aaron Tobian, MD, PhD||Johns Hopkins University|