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

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

ArmDescriptionAssigned 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.
  • Biological: Red Blood Cell Transfusion
    Transfusion of packed red blood cell units
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.
  • Biological: Red Blood Cell Transfusion
    Transfusion of packed red blood cell units

Recruiting Locations

Central Arkansas Veterans Healthcare System
Little Rock, Arkansas 72205

University of Arkansas Medical Sciences (UAMS) Hospital
Little Rock, Arkansas 72205

Rush University Medical Center
Chicago, Illinois 60612

University of Chicago Medical Center
Chicago, Illinois 60637
Contact:
Mary Harris-Moreno

Alexian Brothers Medical Center
Elk Grove Village, Illinois 60007

AMITA Health
Hinsdale, Illinois 60521

Saint Luke's Mid America Heart
Kansas City, Kansas 64111

University of Louisville
Louisville, Kentucky 40202

Boston Medical Center
Boston, Massachusetts 02118

Beth Israel Deaconess Medical Center
Boston, Massachusetts 15261

University of Michigan
Ann Arbor, Michigan 48109

St. Joseph Mercy Health System
Ypsilanti, Michigan 48197

Minneapolis Heart Institute (Foundation)
Minneapolis, Minnesota 55407-1130

Mayo Clinic
Rochester, Minnesota 55905

Memorial Hospital at Gulfport
Gulfport, Mississippi 39502

Washington University
Saint Louis, Missouri 63110

Copper University Hospital
Camden, New Jersey 08103

Hackensacjk University Medical Center
Hackensack, New Jersey 07601

Jersey Shore University Medical
Neptune, New Jersey 08759

Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08903
Contact:
Jeffrey L Carson, MD
732-235-7122
jeffrey.carson@rutgers.edu

University of New Mexico
Albuquerque, New Mexico 87131

Albany Medical College
Albany, New York 12208

Southside Hospital
Bay Shore, New York 11706

Montefiore Medical Center
Bronx, New York 10467

NYP Brooklyn Methodist
Brooklyn, New York 11215

New York Presbyterian/Queens
Flushing, New York 11355

Westchester Medical Center
Hawthorne, New York 10532

NYU Langone Medical Center, Bellevue Hospital
New York, New York 10016

Lenox Hilll Hospital
New York, New York 10075

Rochester General Hospital
Rochester, New York 14450

Northwell Staten Island Hopsital
Staten Island, New York 10305

Stony Brook Medicine
Stony Brook, New York 11794-8167

The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599-7097

Durham Va
Durham, North Carolina 27705

WakeMed Health and Hospital
Raleigh, North Carolina 27610

Aultman Hospital
Canton, Ohio 44710
Contact:
Jeannie Archinai

University of Toledo Medical Center
Toledo, Ohio 43614

Lancaster General Hospital
Lancaster, Pennsylvania 17602

PENN Presbyterian Medical Cente
Philadelphia, Pennsylvania 19104

Thomas Jefferson University
Philadelphia, Pennsylvania 19107

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15261

Lankenau Medical Center
Wynnewood, Pennsylvania 19096

Rhode Island Hospital
Providence, Rhode Island 02903

The Miriam Hospital
Providence, Rhode Island 02906

The Memphis VAMC
Memphis, Tennessee 38104

Baylor St Luke's Medical Center
Houston, Texas 77030

University of Vermont Medical Center
Burlington, Vermont 05401

Virginia Commonwealth University
Richmond, Virginia 23298

Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin 53226
Contact:
Barbara Shimada-Krouwer, RN BSB

More Details

NCT ID
NCT02981407
Status
Recruiting
Sponsor
Rutgers, The State University of New Jersey

Study Contact

Jeffrey L Carson, MD
732-235-7122
Jeffrey.Carson@Rutgers.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.