Clinical trial NCT02981407: Myocardial Ischemia and Transfusion
Official title: Myocardial Ischemia and Transfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Anemia
Keywords: Red Blood Cell Transfusion
Anemia
Heart Disease
Cardiovascular Disease
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-12-05
Enrollment: 3506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction
timeFrame: Within 30 days of randomization
Secondary outcomes:
measure: All-cause Mortality
timeFrame: Within 30 days of randomization
measure: Myocardial Reinfarction
timeFrame: Within 30 days of randomization
measure: Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis
timeFrame: Within 30 days of randomization
Other outcomes:
measure: Composite of All-cause Mortality,Nonfatal Myocardial Reinfarction, or Unstable Angina
timeFrame: Within 30 days of randomization
measure: Ischemia Driven Unscheduled Coronary Revascularization
timeFrame: Within 30 days of randomization
measure: Unscheduled Readmission to Hospital for Ischemic Cardiac Diagnosis
timeFrame: Within 30 days of randomization
measure: Heart Failure
timeFrame: Within 30 days of randomization
measure: Unscheduled Readmission to Hospital for Any Reason
timeFrame: Within 30 days of randomization
measure: Stroke
timeFrame: Within 30 days of randomization
measure: Pulmonary Embolism or Deep Venous Thrombosis
timeFrame: Within 30 days of randomization
measure: Bleed
timeFrame: Within 30 days of randomization
measure: Pneumonia
timeFrame: Within 30 days of randomization
measure: Blood Stream Infection
timeFrame: Within 30 days of randomization
measure: Urinary Tract Infection
timeFrame: Within 30 days of randomization
measure: Length of Hospital Stay Post Randomization
timeFrame: Within 30 days of randomization
measure: Number of Days Post Randomization in Intensive Care Unit
timeFrame: Within 30 days of randomization
measure: Patient Reported Quality of Life
timeFrame: Within 30 days of randomization
measure: All-cause Mortality
timeFrame: Within 6 months of randomization
Locations:
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas Medical Sciences (UAMS) Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: VAGLAHS
state: California
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Hinsdale
country: United States
facility: AMITA Health
state: Illinois
city: Kansas City
country: United States
facility: Saint Luke's Mid America Heart
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Health System
state: Michigan
city: Duluth
country: United States
facility: Essentia Health
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute (Foundation)
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Gulfport
country: United States
facility: Memorial Hospital at Gulfport
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Camden
country: United States
facility: Copper University Hospital
state: New Jersey
city: Hackensack
country: United States
facility: Hackensacjk University Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Bay Shore
country: United States
facility: Southside Hospital
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: NYP Brooklyn Methodist
state: New York
city: Flushing
country: United States
facility: New York Presbyterian/Queens
state: New York
city: Hawthorne
country: United States
facility: Westchester Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center, Bellevue Hospital
state: New York
city: New York
country: United States
facility: Lenox Hilll Hospital
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Staten Island
country: United States
facility: Northwell Staten Island Hopsital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Durham Va
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Health and Hospital
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: PENN Presbyterian Medical Cente
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Memphis
country: United States
facility: The Memphis VAMC
state: Tennessee
city: Houston
country: United States
facility: Baylor St Luke's Medical Center
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin - Froedtert Hospital
state: Wisconsin
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
city: Gosford
country: Australia
facility: Gosford Hospital
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Pituba
country: Brazil
facility: Instituto de Ensino e Pesquisa do Hospital da Bahia
state: Salvador
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de Rio Preto
state: São Paulo
city: Belo Horizonte
country: Brazil
facility: Hospital Felício Rocho
city: Belo Horizonte
country: Brazil
facility: Instituto Orizonti
city: Brasília
country: Brazil
facility: Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil
city: Campinas
country: Brazil
facility: Hospital Vera Cruz
city: Cascata
country: Brazil
facility: Santa Casa de Marília
city: Centro
country: Brazil
facility: Sociedade Hospitalar Angelina Caron
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do RS
city: Poços De Caldas
country: Brazil
facility: Hospital Maternidade e Pronto Socorro Santa Lúcia
city: Recife
country: Brazil
facility: Hospital Agamenon Magalhães
city: Recife
country: Brazil
facility: Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE
city: Salvador
country: Brazil
facility: Hospital Cárdio Pulmonar
city: Salvador
country: Brazil
facility: Hospital Universitário Professor Edgard Santos
city: São José Do Rio Preto
country: Brazil
facility: Hospital de Base de Rio Preto
city: São Paulo
country: Brazil
facility: Hospital São Paulo
city: Uberaba
country: Brazil
facility: Hospital de Clínicas da UFTM
city: Uberlândia
country: Brazil
facility: Hospital das Clinicas da UFU
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Halifax
country: Canada
facility: QE II Health Sciences Center
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton St. Joseph's Health
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
city: London
country: Canada
facility: University Hospital - LHSC
state: Ontario
city: London
country: Canada
facility: Victoria Hospital - LHSC
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Victoria
country: Canada
facility: Victoria Heart Institute
state: Ontario
city: Greenfield Park
country: Canada
facility: Hôpital Charles Lemoyne
state: Quebec
city: Levis
country: Canada
facility: Hotel-Dieu de Levis
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: Centre Hosp. Universitaire de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montréal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Québec City
country: Canada
facility: Quebec Heart and Lung Institute
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Trois-Rivières
country: Canada
facility: General Hospital Trois-Rivièrs
state: Quebec
city: Regina
country: Canada
facility: Regina General Hospital
state: Saskatchewan
city: Chambray-lès-Tours
country: France
facility: CHRU Tours -Hôpital Trousseau
city: Chartres
country: France
facility: CH Chartres - Chartres
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Dijon
country: France
facility: CHU le Bocage - Dijon
city: La Tronche
country: France
facility: La Tronche Hôpital Michallon
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve - Montpellier
city: Nancy
country: France
facility: CHU Nancy
city: Nice
country: France
facility: Hôpital Pasteur
city: Nîmes
country: France
facility: Hôpital Universitaire Carémeau (CHU Carémeau)
city: Paris
country: France
facility: Hôpital La Pitié Salpétrière
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou
city: Paris
country: France
facility: Hôpital BICHAT- APHP
city: Paris
country: France
facility: Hôpital Lariboisière
city: Pessac
country: France
facility: Hôpital Haut Lévêque
city: Poitiers
country: France
facility: CHU Poitiers - Poitiers
city: Rouen
country: France
facility: Hôpital Charles Nicolle- Rouen
city: Toulouse
country: France
facility: Hôpital Rangueil
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Gisborne
country: New Zealand
facility: Gisborne Hospital
city: Nelson
country: New Zealand
facility: Nelson Hospital
city: New Plymouth
country: New Zealand
facility: Taranaki Hospital
city: Whangarei
country: New Zealand
facility: Whangarei Hospital
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Jeffrey L Carson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Maria Mori Brooks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.