Myocardial Ischemia and Transfusion (MINT)

  • STATUS
    Recruiting
  • End date
    Oct 11, 2023
  • participants needed
    3500
  • sponsor
    Rutgers, The State University of New Jersey
Updated on 11 May 2022
Investigator
Jeffrey L Carson, MD
Primary Contact
Regina General Hospital (0.0 mi away) Contact
+123 other location
myocardial infarction
stemi
infarct
ischemia
blood transfusion
red blood cell transfusion
acute myocardial infarction

Summary

The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

Description

In most clinical settings, evidence suggests it is safe to wait to give a blood transfusion. However, for those who have suffered a heart attack, there is a lack of high quality evidence to guide transfusions. This 3500 subject multi-center randomized trial will fill that void.

Hospital inpatients diagnosed with myocardial infarction who have blood counts less than 10 g/dL are randomized to receive either a liberal or a restrictive transfusion strategy.

Patients randomized to the liberal transfusion strategy will receive a red blood cell transfusion anytime there is a blood count of less than 10 g/dL.

Patients randomized to the restrictive transfusion strategy are permitted to receive a blood transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion is ordered regardless of the blood count.

The transfusions strategies will be maintained until hospital discharge for a maximum of 30 days.

Patients will be followed for 30 days for clinically relevant outcomes. Vital status will be confirmed at 180 days.

Details
Condition Myocardial Infarction, Anemia
Treatment red blood cell transfusion
Clinical Study IdentifierNCT02981407
SponsorRutgers, The State University of New Jersey
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

years of age or older
Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization
Hemoglobin concentration less than 10 g/dL at the time of random allocation
Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient

Exclusion Criteria

Uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood
Decline blood transfusion
Scheduled for cardiac surgery during the current admission
Receiving only palliative treatment
Known that follow-up will not be possible at 30 days
Previously participated in MINT
Currently enrolled in a competing study that interferes with the intervention or follow-up of MINT or enrolled in a competing study that has not been approved by the local Institutional Review Board
Patient physician does not believe the patient is an appropriate candidate for the trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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