NCT02619136

Brief Summary

MINT: A pilot, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in patients with myocardial infarction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,501

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

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 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

June 30, 2016

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

7.4 years

First QC Date

November 30, 2015

Last Update Submit

July 24, 2023

Conditions

Myocardial Infarction

Keywords

Blood Transfusion

Outcome Measures

Primary Outcomes (2)

  • Enrollment rate

    Recruitment will be estimated over a 6 months period at each center

    Time Frame: 6 months

  • Non-adherence

    Non-adherence will be defined as transfusing a patient allocated to the restrictive group if the hemoglobin level is greater than 80 g/L; in the liberal group, not transfusing a patient who has a hemoglobin less than 100 g/L for at least 48 hours with at least 2 consecutive values.

    30 days

Secondary Outcomes (1)

  • Recurrent non-fatal myocardial infarction

    30 days

Study Arms (2)

Restrictive Transfusion Strategy

EXPERIMENTAL

We will permit but not require red cell transfusions once a hemoglobin value falls below 80 g/L (required below 70 g/L) during the 30 days following randomization

Procedure: Transfusion

Liberal Transfusion Strategy

ACTIVE COMPARATOR

We will transfuse at a transfusion threshold of 100 g/L for up to 30 days after randomization.

Procedure: Transfusion

Interventions

TransfusionPROCEDURE

Red Blood Cell Transfusion

Liberal Transfusion StrategyRestrictive Transfusion Strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patients with hemoglobin level less than 100 g/L who present with an ST-segment Elevation Myocardial Infarction (STEMI), or Non-ST-Elevation Myocardial Infarction (NSTEMI);
  • Rise in cardiac biomarker values with at least one value above the 99th percentile (preferably cardiac troponin cTn )
  • Presence of one of the following:
  • symptoms of ischemia;
  • new/presumed new ST segment-T wave (ST-T) changes or new left bundle branch (LBBB);
  • development of pathological Q waves;
  • imaging evidence of new loss of viable myocardium or new regional wall motion abnormality;
  • identification of an intracoronary thrombus by angiography

You may not qualify if:

  • Patients with uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood;
  • Patients who decline blood transfusion;
  • Patients who have a planned cardiac surgery or immediate post-cardiac surgery;Patients who have been deemed palliative by their treatment team (no commitment to aggressive on-going care);
  • If known that follow-up will not be possible at 30 days;
  • Previous participation in the MINT Trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alberta Heart Institute

Edmonton, Alberta, Canada

Location

Victoria Heart Institute

Victoria, British Columbia, Canada

Location

Centre Hospitalier de l'Universite de Montreal-Hotel Dieu

Montreal, Quebec, H2X 0A9, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie

Québec, Quebec, Canada

Location

Related Publications (2)

  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

  • Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

    PMID: 34932836DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Paul Hébert, MD

    Centre Hospitalier de l'Universite de Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 2, 2015

Study Start

June 30, 2016

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

CA(4)