NCT02981407

Myocardial Ischemia and Transfusion

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,506 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction
• Anemia

Interventions

Type	Name	Description
BIOLOGICAL	Red Blood Cell Transfusion	Transfusion of packed red blood cell units

Timeline

• Start date: 2017-04-25
• Primary completion: 2023-05-31
• Completion: 2023-10-20
• First posted: 2016-12-05
• Last updated: 2024-05-09
• Results posted: 2024-05-09

Locations

133 sites across 6 countries: United States, Australia, Brazil, Canada, France, New Zealand

Regulatory

• FDA-regulated drug study