Myocardial Ischemia and Transfusion

Phase 3

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

18 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

Primary Outcome Measures

Name	Time	Method
Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction	Within 30 days of randomization

Secondary Outcome Measures

Name	Time	Method
Myocardial Reinfarction	Within 30 days of randomization
All-cause Mortality	Within 30 days of randomization
Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis	Within 30 days of randomization

Locations (132): Central Arkansas Veterans Healthcare System
🇺🇸
Little Rock, Arkansas, United States
University of Arkansas Medical Sciences (UAMS) Hospital
🇺🇸
Little Rock, Arkansas, United States
VAGLAHS
🇺🇸
Los Angeles, California, United States
Danbury Hospital
🇺🇸
Danbury, Connecticut, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸
Chicago, Illinois, United States
Alexian Brothers Medical Center
🇺🇸
Elk Grove Village, Illinois, United States
AMITA Health
🇺🇸
Hinsdale, Illinois, United States
Saint Luke's Mid America Heart
🇺🇸
Kansas City, Kansas, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
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Central Arkansas Veterans Healthcare System
🇺🇸Little Rock, Arkansas, United States