Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3506 participants
INTERVENTIONAL
2017-04-25
2023-10-20
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Red Blood Cell Transfusion
Transfusion of packed red blood cell units
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.
Red Blood Cell Transfusion
Transfusion of packed red blood cell units
Interventions
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Red Blood Cell Transfusion
Transfusion of packed red blood cell units
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Jeffrey L Carson, MD
Principal Investigator
Principal Investigators
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Jeffrey L Carson, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Robert Wood Johnson Medical School
Maria Mori Brooks, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States
University of Arkansas Medical Sciences (UAMS) Hospital
Little Rock, Arkansas, United States
VAGLAHS
Los Angeles, California, United States
Danbury Hospital
Danbury, Connecticut, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
AMITA Health
Hinsdale, Illinois, United States
Saint Luke's Mid America Heart
Kansas City, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Hospital
Burlington, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
St. Joseph Mercy Health System
Ypsilanti, Michigan, United States
Essentia Health
Duluth, Minnesota, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
Minneapolis Heart Institute (Foundation)
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, United States
Washington University
St Louis, Missouri, United States
Copper University Hospital
Camden, New Jersey, United States
Hackensacjk University Medical Center
Hackensack, New Jersey, United States
Jersey Shore University Medical
Neptune City, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Albany Medical College
Albany, New York, United States
Southside Hospital
Bay Shore, New York, United States
NYP Brooklyn Methodist
Brooklyn, New York, United States
New York Presbyterian/Queens
Flushing, New York, United States
Westchester Medical Center
Hawthorne, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Northern Westchester Hospital
Mount Kisco, New York, United States
NYU Langone Medical Center, Bellevue Hospital
New York, New York, United States
Lenox Hilll Hospital
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Northwell Staten Island Hopsital
Staten Island, New York, United States
Stony Brook Medicine
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Durham Va
Durham, North Carolina, United States
WakeMed Health and Hospital
Raleigh, North Carolina, United States
Aultman Hospital
Canton, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
PENN Presbyterian Medical Cente
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Greenville Health System
Greenville, South Carolina, United States
The Memphis VAMC
Memphis, Tennessee, United States
Baylor St Luke's Medical Center
Houston, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, United States
Flinders Medical Centre
Bedford Park, , Australia
Concord Repatriation General Hospital
Concord, , Australia
Gosford Hospital
Gosford, , Australia
Royal Perth Hospital
Perth, , Australia
Instituto de Ensino e Pesquisa do Hospital da Bahia
Pituba, Salvador, Brazil
Hospital de Base de Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital Felício Rocho
Belo Horizonte, , Brazil
Instituto Orizonti
Belo Horizonte, , Brazil
Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil
Brasília, , Brazil
Hospital Vera Cruz
Campinas, , Brazil
Santa Casa de Marília
Cascata, , Brazil
Sociedade Hospitalar Angelina Caron
Centro, , Brazil
Hospital Maternidade e Pronto Socorro Santa Lúcia
Poços de Caldas, , Brazil
Instituto de Cardiologia do RS
Porto Alegre, , Brazil
Hospital Agamenon Magalhães
Recife, , Brazil
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE
Recife, , Brazil
Hospital Cárdio Pulmonar
Salvador, , Brazil
Hospital Universitário Professor Edgard Santos
Salvador, , Brazil
Hospital de Base de Rio Preto
São José do Rio Preto, , Brazil
Hospital São Paulo
São Paulo, , Brazil
Hospital de Clínicas da UFTM
Uberaba, , Brazil
Hospital das Clinicas da UFU
Uberlândia, , Brazil
Foothills Medical Centre
Calgary, Alberta, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Royal Columbian Hospital
New Westminster, British Columbia, Canada
Surrey Memorial Hospital
Surrey, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
QE II Health Sciences Center
Halifax, Nova Scotia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
Hamilton St. Joseph's Health
Hamilton, Ontario, Canada
St. Joseph's Health Centre
Hamilton, Ontario, Canada
University Hospital - LHSC
London, Ontario, Canada
Victoria Hospital - LHSC
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Victoria Heart Institute
Victoria, Ontario, Canada
Hôpital Charles Lemoyne
Greenfield Park, Quebec, Canada
Hotel-Dieu de Levis
Lévis, Quebec, Canada
Centre Hosp. Universitaire de Montréal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Quebec Heart and Lung Institute
Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
General Hospital Trois-Rivièrs
Trois-Rivières, Quebec, Canada
Regina General Hospital
Regina, Saskatchewan, Canada
CHRU Tours -Hôpital Trousseau
Chambray-lès-Tours, , France
CH Chartres - Chartres
Chartres, , France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, , France
CHU le Bocage - Dijon
Dijon, , France
La Tronche Hôpital Michallon
La Tronche, , France
Centre Hospitalier Universitaire de Lille
Lille, , France
CHU Arnaud de Villeneuve - Montpellier
Montpellier, , France
CHU Nancy
Nancy, , France
Hôpital Pasteur
Nice, , France
Hôpital Universitaire Carémeau (CHU Carémeau)
Nîmes, , France
Hôpital La Pitié Salpétrière
Paris, , France
Hôpital Européen Georges-Pompidou
Paris, , France
Hôpital BICHAT- APHP
Paris, , France
Hôpital Lariboisière
Paris, , France
Hôpital Haut Lévêque
Pessac, , France
CHU Poitiers - Poitiers
Poitiers, , France
Hôpital Charles Nicolle- Rouen
Rouen, , France
Hôpital Rangueil
Toulouse, , France
Auckland City Hospital
Auckland, , New Zealand
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
Countries
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References
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Carson JL, Brooks MM, Abbott JD, Chaitman B, Kelsey SF, Triulzi DJ, Srinivas V, Menegus MA, Marroquin OC, Rao SV, Noveck H, Passano E, Hardison RM, Smitherman T, Vagaonescu T, Wimmer NJ, Williams DO. Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease. Am Heart J. 2013 Jun;165(6):964-971.e1. doi: 10.1016/j.ahj.2013.03.001. Epub 2013 Apr 8.
Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.
Carson JL, Brooks MM, Chaitman BR, Alexander JH, Goodman SG, Bertolet M, Abbott JD, Cooper HA, Rao SV, Triulzi DJ, Fergusson DA, Kostis WJ, Noveck H, Simon T, Steg PG, DeFilippis AP, Goldsweig AM, Lopes RD, White H, Alsweiler C, Morton E, Hebert PC; MINT Investigators. Rationale and design for the myocardial ischemia and transfusion (MINT) randomized clinical trial. Am Heart J. 2023 Mar;257:120-129. doi: 10.1016/j.ahj.2022.11.015. Epub 2022 Nov 20.
Carson JL, Brooks MM, Hebert PC, Goodman SG, Bertolet M, Glynn SA, Chaitman BR, Simon T, Lopes RD, Goldsweig AM, DeFilippis AP, Abbott JD, Potter BJ, Carrier FM, Rao SV, Cooper HA, Ghafghazi S, Fergusson DA, Kostis WJ, Noveck H, Kim S, Tessalee M, Ducrocq G, de Barros E Silva PGM, Triulzi DJ, Alsweiler C, Menegus MA, Neary JD, Uhl L, Strom JB, Fordyce CB, Ferrari E, Silvain J, Wood FO, Daneault B, Polonsky TS, Senaratne M, Puymirat E, Bouleti C, Lattuca B, White HD, Kelsey SF, Steg PG, Alexander JH; MINT Investigators. Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia. N Engl J Med. 2023 Dec 28;389(26):2446-2456. doi: 10.1056/NEJMoa2307983. Epub 2023 Nov 11.
Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10:CD002042. doi: 10.1002/14651858.CD002042.pub6.
Prochaska MT, Portela GT, Brooks MM, Fergusson DA, Hebert PC, Polonsky TS, Caixeta A, Cooper HA, Crozier I, Daneault B, Kim S, Bainey KR, de Barros E Silva P, Goldfarb M, Gupta R, Rao SV, Fonteles Ritt LE, Simon T, Carson JL. Transfusion Strategy Effect on Quality of Life in Patients With Myocardial Infarction and Anemia: A Secondary Analysis of the MINT Randomized Clinical Trial. JAMA Intern Med. 2025 Aug 1;185(8):947-954. doi: 10.1001/jamainternmed.2025.0654.
Rao SV, Brooks MM, D'Agostino HEA, Steg PG, Simon T, Aronow HD, Goldsweig AM, Malik S, Alsweiler C, Ho KKL, Dehghani P, Caixeta A, Quraishi AR, Robinson S, Traverse JH, Siddiqi O, Fergusson DA, Potter BJ, Schulman-Marcus J, Keating FK, Carson JL; MINT Trial Investigators. Effect of Red Blood Cell Transfusion Strategy on Clinical Outcomes Among Patients With Acute Myocardial Infarction Undergoing Revascularization: A Prespecified Analysis of the MINT Trial. Circ Cardiovasc Interv. 2025 May;18(5):e015249. doi: 10.1161/CIRCINTERVENTIONS.125.015249. Epub 2025 Mar 30.
Goldsweig AM, Kostis WJ, Herbert BM, Bouleti C, Potter BJ, Strom JB, Benatar J, Huynh T, Vallurupalli S, Figueiredo EL, Abbott JD, Cooper HA, DeFilippis AP, Fergusson DA, Goodman SG, Hebert PC, Lopes RD, Rao SV, Simon T, Carson JL, Brooks MM, Alexander JH; MINT Investigators. Blood Transfusion in Patients With Acute Myocardial Infarction, Anemia, and Heart Failure: Lessons From MINT. Circ Heart Fail. 2025 Apr;18(4):e012495. doi: 10.1161/CIRCHEARTFAILURE.124.012495. Epub 2025 Mar 26.
Portela GT, Ducrocq G, Bertolet M, Alexander JH, Goodman SG, Glynn S, Strom JB, Swanson SA, Lemesle G, Rao SV, Tessalee M, Polonsky TS, Goldfarb M, Traverse JH, Uhl L, Herbert BM, Silvain J, Carson JL, Brooks MM; MINT Trial Investigators. Individualized transfusion decisions to minimize adverse cardiovascular outcomes in patients with acute myocardial infarction and anemia. Am Heart J. 2025 Apr;282:146-155. doi: 10.1016/j.ahj.2025.01.009. Epub 2025 Jan 17.
Strom JB, Herbert BM, Bertolet M, Brooks MM, Malik SA, Lemesle G, Madan M, Steg PG, Hebert PC, Traverse JH, White HD, Alsweiler C, Gupta R, Ritt LEF, Menegus MA, Alexander JH, Lopes RD, Chaitman BR, Carson JL; MINT Trial Investigators. Restrictive or Liberal Blood Transfusion in Patients with Myocardial Infarction and CKD. J Am Soc Nephrol. 2025 Jun 1;36(6):1116-1125. doi: 10.1681/ASN.0000000595. Epub 2025 Jan 9.
Carrier FM, Cooper HA, Portela GT, Bertolet M, Lemesle G, Prochaska M, Kim S, Alexander JH, Crozier I, Ducrocq G, Quadros AS, Bagai A, Dracoulakis M, Madan M, Brooks MM, Carson JL, Hebert PC; MINT Investigators. Anemia Acuity Effect on Transfusion Strategies in Acute Myocardial Infarction: A Secondary Analysis of the MINT Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2442361. doi: 10.1001/jamanetworkopen.2024.42361.
Portela GT, Carson JL, Swanson SA, Alexander JH, Hebert PC, Goodman SG, Steg PG, Bertolet M, Strom JB, Fergusson DA, Simon T, White HD, Cooper HA, Abbott JD, Rao SV, Chaitman BR, Fordyce CB, Lopes RD, Daneault B, Brooks MM; MINT Investigators. Effect of Four Hemoglobin Transfusion Threshold Strategies in Patients With Acute Myocardial Infarction and Anemia : A Target Trial Emulation Using MINT Trial Data. Ann Intern Med. 2024 Nov;177(11):1489-1498. doi: 10.7326/M24-0571. Epub 2024 Oct 1.
Simon T, Herbert BM, Brooks MM, Goodman SG, Alexander JH, Steg PG, Lopes RD, Ghafghazi S, Bouleti C, Cooper HA, McCamant EL, Bainey KR, Aronow HD, Abbott JD, Alsweiler C, Bertolet M, Fergusson DA, Goldsweig AM, Hebert PC, Carson JL; MINT Trial Investigators. Restrictive or Liberal Transfusion Strategy in Patients With Acute Myocardial Infarction and Anemia: 6-Month Mortality in the MINT Trial. Circulation. 2024 Sep 24;150(13):1064-1066. doi: 10.1161/CIRCULATIONAHA.124.069917. Epub 2024 Sep 2. No abstract available.
DeFilippis AP, Abbott JD, Herbert BM, Bertolet MH, Chaitman BR, White HD, Goldsweig AM, Polonsky TS, Gupta R, Alsweiler C, Silvain J, de Barros E Silva PGM, Hillis GS, Daneault B, Tessalee M, Menegus MA, Rao SV, Lopes RD, Hebert PC, Alexander JH, Brooks MM, Carson JL, Goodman SG; MINT Investigators. Restrictive Versus Liberal Transfusion in Patients With Type 1 or Type 2 Myocardial Infarction: A Prespecified Analysis of the MINT Trial. Circulation. 2024 Dec 3;150(23):1826-1836. doi: 10.1161/CIRCULATIONAHA.124.071208. Epub 2024 Aug 29.
Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro20160000722
Identifier Type: -
Identifier Source: org_study_id
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