Evidence map›Paper›PMID 35379302›Full record

ArticleTrials2022

The Mirasol Evaluation of Reduction in Infections Trial (MERIT): study protocol for a randomized controlled clinical trial.

Ronnie Kasirye, Heather A Hume, Evan M Bloch, Irene Lubega, Dorothy Kyeyune, Ruchee Shrestha, Henry Ddungu, Hellen Wambongo Musana, Aggrey Dhabangi, Joseph Ouma and 21 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03737669 (Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Emerging Transfusion Transmitted Infections), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03737669 phase3completednot on this map

Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Emerging Transfusion Transmitted Infections

TypeinterventionalSponsorJohns Hopkins UniversityRan2019 to 2025Enrolled2,000ConditionsTransfusion-Transmitted Infectious DiseaseArmsMirasol-treated Fresh Whole Blood, Standard Fresh Whole Blood
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Review
  2. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors.

Ronnie KasiryeMUJHU Research Collaboration, Kampala, Uganda.
Heather A HumeDepartment of Pediatrics, University of Montreal, Montréal, QC, Canada.
Evan M BlochDepartment of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Irene LubegaMUJHU Research Collaboration, Kampala, Uganda.
Dorothy KyeyuneUganda Blood Transfusion Services, Kampala, Uganda.
Ruchee ShresthaDepartment of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Henry DdunguUganda Cancer Institute, Kampala, Uganda.
Hellen Wambongo MusanaMUJHU Research Collaboration, Kampala, Uganda.
Aggrey DhabangiChild Health and Development Centre, Makerere University College of Health Sciences, Kampala, Uganda.
Joseph OumaMUJHU Research Collaboration, Kampala, Uganda.
Priscilla ErojuMUJHU Research Collaboration, Kampala, Uganda.
Telsa de LangeNational Institute of Allergy and Infectious Diseases Office of Cyber Infrastructure and Computational Biology, Bethesda, MD, USA.
Michael TartakovskyNational Institute of Allergy and Infectious Diseases Office of Cyber Infrastructure and Computational Biology, Bethesda, MD, USA.
Jodie L WhiteDepartment of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Ceasar KakuraMUJHU Research Collaboration, Kampala, Uganda.
Mary Glenn FowlerDepartment of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Philippa MusokeMakerere University, Kampala, Uganda.
Monica NolanMUJHU Research Collaboration, Kampala, Uganda.
M Kate GrabowskiDepartment of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Lawrence H MoultonDepartment of International Health, School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
Susan L StramerDepartment of Scientific Affairs, American Red Cross, Gaithersburg, MD, USA.
Denise WhitbyLeidos Biomedical Research, AIDS and Cancer Virus Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Peter A ZimmermanThe Center for Global Health & Diseases, Pathology Department, Case Western Reserve University, Cleveland, OH, USA.
Deo WabwireMUJHU Research Collaboration, Kampala, Uganda.
Isaac KajjaDepartment of Orthopaedics, Makerere University College of Health Sciences, Kampala, Uganda.
Jeffrey McCulloughCollege of Health Solutions, Arizona State University, Phoenix, AZ, USA.
Raymond GoodrichDepartment of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO, USA.
Thomas C QuinnDepartment of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Robert CortesTerumo BCT, Lakewood, CO, USA.
Paul M NessDepartment of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Aaron A R TobianDepartment of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. atobian1@jhmi.edu.ORCID http://orcid.org/0000-0002-0517-3766

Funding

International Center for Excellence in Research (ICER) in Uganda: Impact of ARVsZIAAI001040 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI REYNOLDS, STEVEN · 2009 to 2025
$23.5M
International Studies of the Acquired Immune Deficiency Syndrome (AIDS)ZIAAI000361 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI REDD, ANDREW · 2009 to 2025
$15.8M
Primaquine metabolism and treatment of P. vivax in MadagascarR01AI148469 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI WILLIAMS, SCOTT MATTHEW, ZIMMERMAN, PETER A. · 2020 to 2023
$2.6M
The Malaria Transfusion Risk (MATRix) StudyK23HL151826 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI BLOCH, EVAN MARTIN · 2020 to 2024
$882k
NHLBI NIH HHS K23 HL151826NIAID NIH HHS R01 AI148469U.S. Department of Defense W81XWH1810742
6 · The paper itself

Abstract

backgroundTransfusion-transmitted infections (TTIs) are a global health challenge. One new approach to reduce TTIs is the use of pathogen reduction technology (PRT). In vitro, Mirasol PRT reduces the infectious load in whole blood (WB) by at least 99%. However, there are limited in vivo data on the safety and efficacy of Mirasol PRT. The objective of the Mirasol Evaluation of Reduction in Infections Trial (MERIT) is to investigate whether Mirasol PRT of WB can prevent seven targeted TTIs (malaria, bacteria, human immunodeficiency virus, hepatitis B virus, hepatitis C virus, hepatitis E virus, and human herpesvirus 8).

methodsMERIT is a randomized, double-blinded, controlled clinical trial. Recruitment started in November 2019 and is expected to end in 2024. Consenting participants who require transfusion as medically indicated at three hospitals in Kampala, Uganda, will be randomized to receive either Mirasol-treated WB (n = 1000) or standard WB (n = 1000). TTI testing will be performed on donor units and recipients (pre-transfusion and day 2, day 7, week 4, and week 10 after transfusion). The primary endpoint is the cumulative incidence of one or more targeted TTIs from the Mirasol-treated WB vs. standard WB in a previously negative recipient for the specific TTI that is also detected in the donor unit. Log-binomial regression models will be used to estimate the relative risk reduction of a TTI by 10 weeks associated with Mirasol PRT. The clinical effectiveness of Mirasol WB compared to standard WB products in recipients will also be evaluated. DISCUSSION: Screening infrastructure for TTIs in low-resource settings has gaps, even for major TTIs. PRT presents a fast, potentially cost-effective, and easy-to-use technology to improve blood safety. MERIT is the largest clinical trial designed to evaluate the use of Mirasol PRT for WB. In addition, this trial will provide data on TTIs in Uganda.

trial registrationMirasol Evaluation of Reduction in Infections Trial (MERIT) NCT03737669 . Registered on 9 November 2018.

Indexed as

Transfusion ReactionBlood PlateletsBlood SafetyHumansRandomized Controlled Trials as TopicUgandaMirasolPathogen reductionRandomized controlled trialSub-Saharan AfricaTransfusion-transmitted infectionsUganda

Identifiers

PMID35379302
PMCPMC8978156

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.