Myocardial Ischemia and Transfusion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Myocardial Ischemia and Transfusion

Conditions
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Myocardial Infarction, Anemia

Intervention / Treatment
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* Biological: Red Blood Cell Transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liberal Transfusion Strategy<br>Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. | Biological: Red Blood Cell Transfusion<br>* Transfusion of packed red blood cell units<br>|
| Active Comparator: Restrictive Transfusion Strategy<br>Permitted to receive a red blood cell 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 will be ordered regardless of the blood count. | Biological: Red Blood Cell Transfusion<br>* Transfusion of packed red blood cell units<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome of all-cause mortality or nonfatal myocardial reinfarction |  | Within 30 days of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | Within 30 days of randomization | 
| Myocardial reinfarction |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Red Blood Cell Transfusion, Anemia, Heart Disease, Cardiovascular Disease