Myocardial Ischemia and Transfusion Pilot

Study Overview
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Brief Summary
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The purpose of this study is to evaluate two approaches to red blood cell transfusion in anemic patients with acute coronary syndrome.

Detailed Description
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Red blood cell transfusions are extremely common medical interventions, yet, it remains unclear when patients should be transfused. This pilot study will evaluate the feasibility of conducting a research protocol that will lead to a large scale clinical trial designed to evaluate the treatment effectiveness of two transfusion threshold strategies in patients with coronary artery disease.

Official Title
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Myocardial Ischemia and Transfusion Pilot

Conditions
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Myocardial Infarction, Unstable Angina, Coronary Artery Disease

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: age 18 or older; STEMI (ST segment elevated myocardial infarction) NSTEMI (Non ST segment elevation myocardial infarction) unstable angina stable coronary artery disease (undergoing cardiac catheterization during the index hospitalization); written informed consent has been obtained hemoglobin concentration less than 10 g/dL at the time of random allocation. Exclusion Criteria: bleeding cannot be controlled at the cardiac catheterization puncture site and/or require surgery to repair vessel retroperitoneal bleeding requiring surgery clinically important hemodynamic instability based on the judgment of the treating physician terminal malignancy or life expectancy less than 6 months scheduled for cardiac surgery within the next 30 days symptomatic at the time of randomization declines blood transfusion history of a clinically significant transfusion reaction inability to provide informed consent; enrolled in a competing study previous participation in the MINT trial any patient who in the judgment of the research team should not be enrolled in the trial. This would include, but not be limited to, factors such alcohol or drug dependence, or psychiatric illness.

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 |
| --- | --- |
| Experimental: Liberal Transfusion Strategy<br>Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood 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. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL. | Biological: Red blood cell transfusion<br>* Liberal versus restrictive transfusion<br>|
| Experimental: Restrictive transfusion strategy<br>Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL. Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension. | Biological: Red blood cell transfusion<br>* Liberal versus restrictive transfusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Concentration | Differences in the mean hemoglobin concentrations between the two study arms. | In-hospital up to 30 days post randomization | 
| Red Blood Cell Transfusion | Differences in mean number of units of red blood cell transfusions between the two study arms. | In-hospital up to 30 days post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality or Myocardial Ischemia | Composite 30 day rates of all cause 30 day mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) up to 30 days after randomization, or unscheduled coronary revascularization within 30 days. | 30 days | 
| Mortality or Myocardial Ischemia | Composite 6 month rates of all cause 6 month mortality, recurrent myocardial infarction up to 6 months after randomization, unscheduled coronary revascularization within 6 months. | 6 months | 
| Individual Components of Composite Outcome | All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization. | 30 days | 
| Mortality From Cardiac Causes |  | 30 days | 
| Unscheduled Hospital Admission | Unscheduled hospital admission at 30 days for any reason, for cardiac reason (e.g., acute coronary syndrome, MI, congestive heart failure, or arrhythmia), or infection. | 30 days | 
| Stroke |  | 30 days | 
| Congestive Heart Failure |  | 30 days | 
| Stent Thrombosis |  | 30 days | 
| Deep Vein Thrombosis or Pulmonary Embolism |  | 30 days | 
| Pneumonia or Blood Stream Infection and Each Separately |  | 30 days | 
| Composite Mortality and Morbidity | Composite rates of all cause mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction), or unscheduled coronary revascularization or pneumonia. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood transfusion, red blood cell transfusion, myocardial infarction, acute coronary syndrome, anemia