Myocardial Ischemia and Transfusion
- Conditions
- AnemiaMyocardial Infarction
- Interventions
- Biological: Red Blood Cell Transfusion
- Registration Number
- NCT02981407
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3506
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Restrictive Transfusion Strategy Red Blood Cell Transfusion 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. Liberal Transfusion Strategy Red Blood Cell Transfusion 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.
- Primary Outcome Measures
Name Time Method Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction Within 30 days of randomization
- Secondary Outcome Measures
Name Time Method Myocardial Reinfarction Within 30 days of randomization All-cause Mortality 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
Trial Locations
- Locations (132)
Washington University
🇺🇸Saint Louis, Missouri, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Memorial Hospital at Gulfport
🇺🇸Gulfport, Mississippi, United States
VAGLAHS
🇺🇸Los Angeles, California, United States
Danbury Hospital
🇺🇸Danbury, Connecticut, United States
Lahey Hospital
🇺🇸Burlington, Massachusetts, United States
University of Arkansas Medical Sciences (UAMS) Hospital
🇺🇸Little Rock, Arkansas, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
AMITA Health
🇺🇸Hinsdale, Illinois, United States
Copper University Hospital
🇺🇸Camden, New Jersey, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Hospital Cárdio Pulmonar
🇧🇷Salvador, Brazil
NYP Brooklyn Methodist
🇺🇸Brooklyn, New York, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Essentia Health
🇺🇸Duluth, Minnesota, United States
Flinders Medical Centre
🇦🇺Bedford Park, Australia
WakeMed Health and Hospital
🇺🇸Raleigh, North Carolina, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Northern Westchester Hospital
🇺🇸Mount Kisco, New York, United States
The Memphis VAMC
🇺🇸Memphis, Tennessee, United States
New York Presbyterian/Queens
🇺🇸Flushing, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil
🇧🇷BrasÃlia, Brazil
Albany Medical College
🇺🇸Albany, New York, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
University Hospital - LHSC
🇨🇦London, Ontario, Canada
Hôpital Européen Georges-Pompidou
🇫🇷Paris, France
Grey Nuns Community Hospital
🇨🇦Edmonton, Alberta, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
CHU Arnaud de Villeneuve - Montpellier
🇫🇷Montpellier, France
Westchester Medical Center
🇺🇸Hawthorne, New York, United States
Hôpital Rangueil
🇫🇷Toulouse, France
General Hospital Trois-Rivièrs
🇨🇦Trois-Rivières, Quebec, Canada
NYU Langone Medical Center, Bellevue Hospital
🇺🇸New York, New York, United States
Lenox Hilll Hospital
🇺🇸New York, New York, United States
St. Joseph's Health Centre
🇨🇦Hamilton, Ontario, Canada
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
CHRU Tours -Hôpital Trousseau
🇫🇷Chambray-lès-Tours, France
Hospital FelÃcio Rocho
🇧🇷Belo Horizonte, Brazil
Victoria Hospital - LHSC
🇨🇦London, Ontario, Canada
Hôpital BICHAT- APHP
🇫🇷Paris, France
Montreal General Hospital
🇨🇦Montréal, Quebec, Canada
CH Chartres - Chartres
🇫🇷Chartres, France
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Centre Hospitalier Sud Francilien
🇫🇷Corbeil-Essonnes, France
CHU le Bocage - Dijon
🇫🇷Dijon, France
Auckland City Hospital
🇳🇿Auckland, New Zealand
Hôpital Charles Lemoyne
🇨🇦Greenfield Park, Quebec, Canada
Hotel-Dieu de Levis
🇨🇦Levis, Quebec, Canada
Centre Hosp. Universitaire de Montréal
🇨🇦Montréal, Quebec, Canada
Quebec Heart and Lung Institute
🇨🇦Québec City, Quebec, Canada
Victoria Heart Institute
🇨🇦Victoria, Ontario, Canada
Centre Hospitalier Universitaire de Lille
🇫🇷Lille, France
CHU Nancy
🇫🇷Nancy, France
Hôpital Pasteur
🇫🇷Nice, France
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor St Luke's Medical Center
🇺🇸Houston, Texas, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
St. Joseph Mercy Health System
🇺🇸Ypsilanti, Michigan, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Jersey Shore University Medical
🇺🇸Neptune, New Jersey, United States
Southside Hospital
🇺🇸Bay Shore, New York, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
University of Toledo Medical Center
🇺🇸Toledo, Ohio, United States
Northwell Staten Island Hopsital
🇺🇸Staten Island, New York, United States
Royal Perth Hospital
🇦🇺Perth, Australia
Gosford Hospital
🇦🇺Gosford, Australia
Concord Repatriation General Hospital
🇦🇺Concord, Australia
Hospital Agamenon Magalhães
🇧🇷Recife, Brazil
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE
🇧🇷Recife, Brazil
Hospital das Clinicas da UFU
🇧🇷Uberlândia, Brazil
Hospital de ClÃnicas da UFTM
🇧🇷Uberaba, Brazil
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Regina General Hospital
🇨🇦Regina, Saskatchewan, Canada
Hôpital La Pitié Salpétrière
🇫🇷Paris, France
Hôpital Haut Lévêque
🇫🇷Pessac, France
CHU Poitiers - Poitiers
🇫🇷Poitiers, France
Hôpital Charles Nicolle- Rouen
🇫🇷Rouen, France
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Gisborne Hospital
🇳🇿Gisborne, New Zealand
Nelson Hospital
🇳🇿Nelson, New Zealand
Taranaki Hospital
🇳🇿New Plymouth, New Zealand
Whangarei Hospital
🇳🇿Whangarei, New Zealand
University of Minnesota Medical Center Fairview
🇺🇸Minneapolis, Minnesota, United States
Minneapolis Heart Institute (Foundation)
🇺🇸Minneapolis, Minnesota, United States
Durham Va
🇺🇸Durham, North Carolina, United States
Saint Luke's Mid America Heart
🇺🇸Kansas City, Kansas, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Rochester
🇺🇸Rochester, New York, United States
La Tronche Hôpital Michallon
🇫🇷La Tronche, France
Hôpital Universitaire Carémeau (CHU Carémeau)
🇫🇷Nîmes, France
Hôpital Lariboisière
🇫🇷Paris, France
Sociedade Hospitalar Angelina Caron
🇧🇷Centro, Brazil
Medical College of Wisconsin - Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Instituto de Ensino e Pesquisa do Hospital da Bahia
🇧🇷Pituba, Salvador, Brazil
Hospital de Base de Rio Preto
🇧🇷São José Do Rio Preto, Brazil
Instituto Orizonti
🇧🇷Belo Horizonte, Brazil
Santa Casa de MarÃlia
🇧🇷Cascata, Brazil
Hospital Vera Cruz
🇧🇷Campinas, Brazil
Instituto de Cardiologia do RS
🇧🇷Porto Alegre, Brazil
Hospital Maternidade e Pronto Socorro Santa Lúcia
🇧🇷Poços De Caldas, Brazil
Hospital Universitário Professor Edgard Santos
🇧🇷Salvador, Brazil
Hospital São Paulo
🇧🇷São Paulo, Brazil
QE II Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Stony Brook Medicine
🇺🇸Stony Brook, New York, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
PENN Presbyterian Medical Cente
🇺🇸Philadelphia, Pennsylvania, United States
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Hackensacjk University Medical Center
🇺🇸Hackensack, New Jersey, United States
Royal Victoria Hospital
🇨🇦Montréal, Quebec, Canada
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Surrey Memorial Hospital
🇨🇦Surrey, British Columbia, Canada
Central Arkansas Veterans Healthcare System
🇺🇸Little Rock, Arkansas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Hamilton St. Joseph's Health
🇨🇦Hamilton, Ontario, Canada
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States