Transfusion-Transmitted Infectious DiseasePhase 3MERITNCT03737669
Mirasol Evaluation of Reduction in Infections Trial
A Phase 3 study testing Mirasol-treated Fresh Whole Blood and Standard Fresh Whole Blood in people with Transfusion-Transmitted Infectious Disease, run by Johns Hopkins University at 1 site in Uganda.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transfusion-Transmitted Infectious Disease
- What is being tested?
- Mirasol-treated Fresh Whole Blood and Standard Fresh Whole Blood
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 1 siteUganda
- Study dates
- 13 Nov 2019to 29 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Emerging Transfusion Transmitted Infections
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.
Read the 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.
- Being tested
- Mirasol-treated Fresh Whole Blood, Standard Fresh Whole Blood
- Keywords
- transfusion, pathogen reduction technology, Uganda, tranfusion transmitted infections, Mirasol, blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Mirasol-treated Fresh Whole Blood | Experimental | Standard Fresh Whole Blood, treated with Mirasol Pathogen Reduction Technology Receives: Biological: Mirasol-treated Fresh Whole Blood |
| Standard Fresh Whole Blood | Placebo comparator | Standard-issue fresh whole blood Receives: Biological: Standard Fresh Whole Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start13 Nov 2019
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transfusion-Transmitted Infectious DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo BCT, MU-JHU CARE, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Aaron Tobian, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737669
- Sponsor's protocol ID
- IRB00174892
- Acronym
- MERIT
- Status last verified
- Oct 2025
- First submitted
- 8 Nov 2018
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35379302
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Emerging Transfusion Transmitted Infections
- ClinicalTrials.gov ID
- NCT03737669
- Acronym / sponsor ID
- MERIT / IRB00174892
- Keywords
- transfusion, pathogen reduction technology, Uganda, tranfusion transmitted infections, Mirasol, blood
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Terumo BCT, MU-JHU CARE, United States Department of Defense
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirasol-treated Fresh Whole Blood | Experimental | Biological: Mirasol-treated Fresh Whole BloodStandard Fresh Whole Blood, treated with Mirasol Pathogen Reduction Technology |
| Standard Fresh Whole Blood | Placebo comparator | Biological: Standard Fresh Whole BloodStandard-issue fresh whole blood |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirasol-treated Fresh Whole BloodStandard 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 | Mirasol-treated Fresh Whole Blood |
| Standard Fresh Whole BloodFresh 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. | Biological | Standard Fresh Whole Blood |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Derived from this study: PubMed 35379302Kasirye 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Tobian, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mirasol-treated Fresh Whole Blood and Standard Fresh Whole Blood in people with Transfusion-Transmitted Infectious Disease, run by Johns Hopkins University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of at least one (1) pre-defined TTI (time frame: Up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03737669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.