Myocardial Ischemia and Transfusion
Purpose
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.
Conditions
- Myocardial Infarction
- Anemia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Liberal Transfusion Strategy |
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. |
|
|
Active Comparator Restrictive Transfusion Strategy |
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. |
|
Recruiting Locations
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Chicago, Illinois 60612
Chicago, Illinois 60637
Mary Harris-Moreno
Elk Grove Village, Illinois 60007
Hinsdale, Illinois 60521
Kansas City, Kansas 64111
Louisville, Kentucky 40202
Boston, Massachusetts 02118
Boston, Massachusetts 15261
Ann Arbor, Michigan 48109
Ypsilanti, Michigan 48197
Minneapolis, Minnesota 55407-1130
Rochester, Minnesota 55905
Gulfport, Mississippi 39502
Saint Louis, Missouri 63110
Camden, New Jersey 08103
Hackensack, New Jersey 07601
Neptune, New Jersey 08759
New Brunswick, New Jersey 08903
Albuquerque, New Mexico 87131
Albany, New York 12208
Bay Shore, New York 11706
Bronx, New York 10467
Brooklyn, New York 11215
Flushing, New York 11355
Hawthorne, New York 10532
New York, New York 10016
New York, New York 10075
Rochester, New York 14450
Staten Island, New York 10305
Stony Brook, New York 11794-8167
Chapel Hill, North Carolina 27599-7097
Durham, North Carolina 27705
Raleigh, North Carolina 27610
Canton, Ohio 44710
Jeannie Archinai
Toledo, Ohio 43614
Lancaster, Pennsylvania 17602
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19107
Pittsburgh, Pennsylvania 15261
Wynnewood, Pennsylvania 19096
Providence, Rhode Island 02903
Providence, Rhode Island 02906
Memphis, Tennessee 38104
Houston, Texas 77030
Burlington, Vermont 05401
Richmond, Virginia 23298
Milwaukee, Wisconsin 53226
Barbara Shimada-Krouwer, RN BSB
More Details
- NCT ID
- NCT02981407
- Status
- Recruiting
- Sponsor
- Rutgers, The State University of New Jersey
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.