Clinical trial NCT03737669: Mirasol Evaluation of Reduction in Infections Trial
Official title: Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Emerging Transfusion Transmitted Infections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Transfusion-Transmitted Infectious Disease
Keywords: transfusion
pathogen reduction technology
Uganda
tranfusion transmitted infections
Mirasol
blood
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Terumo BCT
name: MU-JHU CARE
name: United States Department of Defense
First posted: 2018-11-09
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Cumulative incidence of at least one (1) pre-defined TTI
timeFrame: Up to 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital Complex
Study officials:
affiliation: Johns Hopkins University
name: Aaron Tobian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kasirye R, Hume HA, Bloch EM, Lubega I, Kyeyune D, Shrestha R, Ddungu H, Musana HW, Dhabangi A, Ouma J, Eroju P, de Lange T, Tartakovsky M, White JL, Kakura C, Fowler MG, Musoke P, Nolan M, Grabowski MK, Moulton LH, Stramer SL, Whitby D, Zimmerman PA, Wabwire D, Kajja I, McCullough J, Goodrich R, Quinn TC, Cortes R, Ness PM, Tobian AAR. The Mirasol Evaluation of Reduction in Infections Trial (MERIT): study protocol for a randomized controlled clinical trial. Trials. 2022 Apr 4;23(1):257. doi: 10.1186/s13063-022-06137-8.