MedTrace Logo

Mirasol Evaluation of Reduction in Infections Trial

NCT03737669 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2025-10-06

No results posted yet for this study

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.

Conditions

  • Transfusion-Transmitted Infectious Disease

Interventions

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.

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.

Sponsors & Collaborators

  • Terumo BCT

    collaborator INDUSTRY

  • MU-JHU CARE

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Aaron Tobian, MD, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2025-09-29
Completion
2025-09-29

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03737669 on ClinicalTrials.gov