NCT03737669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

November 13, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2025

Completed
Last Updated

October 6, 2025

Status Verified

October 1, 2025

Enrollment Period

5.9 years

First QC Date

November 8, 2018

Last Update Submit

October 2, 2025

Conditions

Transfusion-Transmitted Infectious Disease

Keywords

transfusionpathogen reduction technologyUgandatranfusion transmitted infectionsMirasolblood

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of at least one (1) pre-defined TTI

    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

Study Arms (2)

Mirasol-treated Fresh Whole Blood

EXPERIMENTAL

Standard Fresh Whole Blood, treated with Mirasol Pathogen Reduction Technology

Biological: Mirasol-treated Fresh Whole Blood

Standard Fresh Whole Blood

PLACEBO COMPARATOR

Standard-issue fresh whole blood

Biological: Standard Fresh Whole Blood

Interventions

Mirasol-treated Fresh Whole BloodBIOLOGICAL

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.

Mirasol-treated Fresh Whole Blood
Standard Fresh Whole BloodBIOLOGICAL

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.

Standard Fresh Whole Blood

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago Hospital Complex

Kampala, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 35379302DERIVED

Study Officials

  • Aaron Tobian, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 9, 2018

Study Start

November 13, 2019

Primary Completion

September 29, 2025

Study Completion

September 29, 2025

Last Updated

October 6, 2025

Record last verified: 2025-10

Locations

UG(1)