Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mirasol Evaluation of Reduction in Infections Trial (MERIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03737669
Recruitment Status : Not yet recruiting
First Posted : November 9, 2018
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
Terumo BCT
MU-JHU CARE
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Transfusion-Transmitted Infectious Disease Biological: Mirasol-treated Fresh Whole Blood Biological: Standard Fresh Whole Blood Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Ruchee Shrestha, MPH 410-614-1902 ruchee@jhu.edu
Contact: Amber Bassett abassett1@jhmi.edu

Locations
Layout table for location information
Uganda
Mulago Hospital Complex Not yet recruiting
Kampala, Uganda
Contact: Monica Nolan, MD, MPH    +256 (414) 541-044 ext 204    mnolan@mujhu.org   
Contact: Irene Lubega, MD       ilubrga@mujhu.org   
Sponsors and Collaborators
Johns Hopkins University
Terumo BCT
MU-JHU CARE
Investigators
Layout table for investigator information
Principal Investigator: Aaron Tobian, MD, PhD Johns Hopkins University

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03737669     History of Changes
Other Study ID Numbers: IRB00174892
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
transfusion
pathogen reduction technology
Uganda
tranfusion transmitted infections
Mirasol
blood

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Transfusion Reaction
Hematologic Diseases
Immune System Diseases