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Myocardial Ischemia and Transfusion (MINT)

Primary Purpose

Myocardial Infarction, Anemia

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Red Blood Cell Transfusion
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Red Blood Cell Transfusion, Anemia, Heart Disease, Cardiovascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Arkansas Veterans Healthcare System
  • University of Arkansas Medical Sciences (UAMS) Hospital
  • VAGLAHS
  • Danbury Hospital
  • Rush University Medical Center
  • University of Chicago Medical Center
  • Alexian Brothers Medical Center
  • AMITA Health
  • Saint Luke's Mid America Heart
  • University of Louisville
  • Tulane University School of Medicine
  • Massachusetts General Hospital
  • Boston Medical Center
  • Beth Israel Deaconess Medical Center
  • Lahey Hospital
  • University of Michigan
  • St. Joseph Mercy Health System
  • Essentia Health
  • University of Minnesota Medical Center Fairview
  • Minneapolis Heart Institute (Foundation)
  • Mayo Clinic
  • Memorial Hospital at Gulfport
  • Washington University
  • Copper University Hospital
  • Hackensacjk University Medical Center
  • Jersey Shore University Medical
  • Robert Wood Johnson University Hospital
  • University of New Mexico
  • Albany Medical College
  • Southside Hospital
  • Montefiore Medical Center
  • NYP Brooklyn Methodist
  • New York Presbyterian/Queens
  • Westchester Medical Center
  • North Shore University Hospital
  • Northern Westchester Hospital
  • NYU Langone Medical Center, Bellevue Hospital
  • Lenox Hilll Hospital
  • Rochester General Hospital
  • University of Rochester
  • Northwell Staten Island Hopsital
  • Stony Brook Medicine
  • The University of North Carolina at Chapel Hill
  • Durham Va
  • WakeMed Health and Hospital
  • Aultman Hospital
  • University of Toledo Medical Center
  • Lancaster General Hospital
  • PENN Presbyterian Medical Cente
  • Thomas Jefferson University
  • University of Pittsburgh Medical Center
  • Lankenau Medical Center
  • Rhode Island Hospital
  • The Miriam Hospital
  • Greenville Health System
  • The Memphis VAMC
  • Baylor St Luke's Medical Center
  • University of Vermont Medical Center
  • Virginia Commonwealth University
  • Medical College of Wisconsin - Froedtert Hospital
  • Flinders Medical Centre
  • Concord Repatriation General Hospital
  • Gosford Hospital
  • Royal Perth Hospital
  • Instituto de Ensino e Pesquisa do Hospital da Bahia
  • Hospital de Base de Rio Preto
  • Hospital Felício Rocho
  • Instituto Orizonti
  • Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil
  • Hospital Vera Cruz
  • Santa Casa de Marília
  • Sociedade Hospitalar Angelina Caron
  • Instituto de Cardiologia do RS
  • Hospital Maternidade e Pronto Socorro Santa Lúcia
  • Hospital Agamenon Magalhães
  • Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE
  • Hospital Cárdio Pulmonar
  • Hospital Universitário Professor Edgard Santos
  • Hospital de Base de Rio Preto
  • Hospital São Paulo
  • Hospital de Clínicas da UFTM
  • Hospital das Clinicas da UFU
  • Foothills Medical Centre
  • Grey Nuns Community Hospital
  • Royal Alexandra Hospital
  • University of Alberta Hospital
  • Royal Columbian Hospital
  • Surrey Memorial Hospital
  • Vancouver General Hospital
  • St. Boniface General Hospital
  • QE II Health Sciences Center
  • Hamilton Health Sciences
  • Hamilton St. Joseph's Health
  • St. Joseph's Health Centre
  • University Hospital - LHSC
  • Victoria Hospital - LHSC
  • St. Michael's Hospital
  • Sunnybrook Health Sciences Centre
  • Victoria Heart Institute
  • Hôpital Charles Lemoyne
  • Hotel-Dieu de Levis
  • Jewish General Hospital
  • Centre Hosp. Universitaire de Montréal
  • Montreal General Hospital
  • Royal Victoria Hospital
  • Quebec Heart and Lung Institute
  • Centre Hospitalier Universitaire de Sherbrooke
  • General Hospital Trois-Rivièrs
  • Regina General Hospital
  • CHRU Tours -Hôpital Trousseau
  • CH Chartres - Chartres
  • Centre Hospitalier Sud Francilien
  • CHU le Bocage - Dijon
  • La Tronche Hôpital Michallon
  • Centre Hospitalier Universitaire de Lille
  • CHU Arnaud de Villeneuve - Montpellier
  • CHU Nancy
  • Hôpital Pasteur
  • Hôpital Universitaire Carémeau (CHU Carémeau)
  • Hôpital La Pitié Salpétrière
  • Hôpital Européen Georges-Pompidou
  • Hôpital BICHAT- APHP
  • Hôpital Lariboisière
  • Hôpital Haut Lévêque
  • CHU Poitiers - Poitiers
  • Hôpital Charles Nicolle- Rouen
  • Hôpital Rangueil
  • Auckland City Hospital
  • Christchurch Hospital
  • Gisborne Hospital
  • Nelson Hospital
  • Taranaki Hospital
  • Whangarei Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Liberal Transfusion Strategy

Restrictive Transfusion Strategy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Composite outcome of all-cause mortality or nonfatal myocardial reinfarction

Secondary Outcome Measures

All-cause mortality
Myocardial reinfarction
Composite of all-cause mortality, nonfatal myocardial reinfarction, ischemia driven unscheduled coronary revascularization, or readmission to the hospital for ischemic cardiac diagnosis

Full Information

First Posted
December 1, 2016
Last Updated
August 22, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
University of Pittsburgh, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02981407
Brief Title
Myocardial Ischemia and Transfusion
Acronym
MINT
Official Title
Myocardial Ischemia and Transfusion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
University of Pittsburgh, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Anemia
Keywords
Red Blood Cell Transfusion, Anemia, Heart Disease, Cardiovascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3506 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liberal Transfusion Strategy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Restrictive Transfusion Strategy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Red Blood Cell Transfusion
Intervention Description
Transfusion of packed red blood cell units
Primary Outcome Measure Information:
Title
Composite outcome of all-cause mortality or nonfatal myocardial reinfarction
Time Frame
Within 30 days of randomization
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
Within 30 days of randomization
Title
Myocardial reinfarction
Time Frame
Within 30 days of randomization
Title
Composite of all-cause mortality, nonfatal myocardial reinfarction, ischemia driven unscheduled coronary revascularization, or readmission to the hospital for ischemic cardiac diagnosis
Time Frame
Within 30 days of randomization
Other Pre-specified Outcome Measures:
Title
Composite of all-cause mortality,nonfatal myocardial reinfarction, or unstable angina
Time Frame
Within 30 days of randomization
Title
Ischemia driven unscheduled coronary revascularization
Time Frame
Within 30 days of randomization
Title
Unscheduled readmission to hospital for ischemic cardiac diagnosis
Time Frame
Within 30 days of randomization
Title
Congestive heart failure
Time Frame
Within 30 days of randomization
Title
Unscheduled readmission to hospital for any reason
Time Frame
Within 30 days of randomization
Title
Stroke
Time Frame
Within 30 days of randomization
Title
Pulmonary embolism or deep venous thrombosis
Time Frame
Within 30 days of randomization
Title
Bleed
Time Frame
Within 30 days of randomization
Title
Pneumonia
Time Frame
Within 30 days of randomization
Title
Blood stream infection
Time Frame
Within 30 days of randomization
Title
Urinary tract infection
Time Frame
Within 30 days of randomization
Title
Length of hospital stay post randomization
Time Frame
Within 30 days of randomization
Title
Number of days post randomization in intensive care unit
Time Frame
Within 30 days of randomization
Title
Patient reported quality of life
Description
EuroQol questionnaire
Time Frame
Within 30 days of randomization
Title
All-cause mortality
Time Frame
Within 6 months of randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Carson, MD
Organizational Affiliation
Rutgers Robert Wood Johnson Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Mori Brooks, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Arkansas Medical Sciences (UAMS) Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
VAGLAHS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
AMITA Health
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Saint Luke's Mid America Heart
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
64111
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
01930
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
15261
Country
United States
Facility Name
Lahey Hospital
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
St. Joseph Mercy Health System
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Essentia Health
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
University of Minnesota Medical Center Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55105
Country
United States
Facility Name
Minneapolis Heart Institute (Foundation)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407-1130
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Memorial Hospital at Gulfport
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39502
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Copper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Hackensacjk University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Jersey Shore University Medical
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
08759
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Southside Hospital
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
NYP Brooklyn Methodist
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
New York Presbyterian/Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Westchester Medical Center
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Northern Westchester Hospital
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
NYU Langone Medical Center, Bellevue Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Lenox Hilll Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14450
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Northwell Staten Island Hopsital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Stony Brook Medicine
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8167
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7097
Country
United States
Facility Name
Durham Va
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
WakeMed Health and Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
PENN Presbyterian Medical Cente
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
The Memphis VAMC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Baylor St Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Medical College of Wisconsin - Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Flinders Medical Centre
City
Bedford Park
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
Country
Australia
Facility Name
Gosford Hospital
City
Gosford
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
Country
Australia
Facility Name
Instituto de Ensino e Pesquisa do Hospital da Bahia
City
Pituba
State/Province
Salvador
ZIP/Postal Code
41810
Country
Brazil
Facility Name
Hospital de Base de Rio Preto
City
São José do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15080-310
Country
Brazil
Facility Name
Hospital Felício Rocho
City
Belo Horizonte
Country
Brazil
Facility Name
Instituto Orizonti
City
Belo Horizonte
Country
Brazil
Facility Name
Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil
City
Brasília
Country
Brazil
Facility Name
Hospital Vera Cruz
City
Campinas
Country
Brazil
Facility Name
Santa Casa de Marília
City
Cascata
ZIP/Postal Code
17515-900
Country
Brazil
Facility Name
Sociedade Hospitalar Angelina Caron
City
Centro
ZIP/Postal Code
83430-000
Country
Brazil
Facility Name
Instituto de Cardiologia do RS
City
Porto Alegre
Country
Brazil
Facility Name
Hospital Maternidade e Pronto Socorro Santa Lúcia
City
Poços De Caldas
Country
Brazil
Facility Name
Hospital Agamenon Magalhães
City
Recife
Country
Brazil
Facility Name
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE
City
Recife
Country
Brazil
Facility Name
Hospital Cárdio Pulmonar
City
Salvador
Country
Brazil
Facility Name
Hospital Universitário Professor Edgard Santos
City
Salvador
Country
Brazil
Facility Name
Hospital de Base de Rio Preto
City
São José Do Rio Preto
Country
Brazil
Facility Name
Hospital São Paulo
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Facility Name
Hospital de Clínicas da UFTM
City
Uberaba
Country
Brazil
Facility Name
Hospital das Clinicas da UFU
City
Uberlândia
Country
Brazil
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
Country
Canada
Facility Name
Surrey Memorial Hospital
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
QE II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Hamilton St. Joseph's Health
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Health Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
University Hospital - LHSC
City
London
State/Province
Ontario
Country
Canada
Facility Name
Victoria Hospital - LHSC
City
London
State/Province
Ontario
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Victoria Heart Institute
City
Victoria
State/Province
Ontario
Country
Canada
Facility Name
Hôpital Charles Lemoyne
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
Hotel-Dieu de Levis
City
Levis
State/Province
Quebec
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre Hosp. Universitaire de Montréal
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Montreal General Hospital
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Quebec Heart and Lung Institute
City
Québec City
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
General Hospital Trois-Rivièrs
City
Trois-Rivières
State/Province
Quebec
Country
Canada
Facility Name
Regina General Hospital
City
Regina
State/Province
Saskatchewan
Country
Canada
Facility Name
CHRU Tours -Hôpital Trousseau
City
Chambray-lès-Tours
Country
France
Facility Name
CH Chartres - Chartres
City
Chartres
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes
Country
France
Facility Name
CHU le Bocage - Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
La Tronche Hôpital Michallon
City
La Tronche
Country
France
Facility Name
Centre Hospitalier Universitaire de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CHU Arnaud de Villeneuve - Montpellier
City
Montpellier
Country
France
Facility Name
CHU Nancy
City
Nancy
Country
France
Facility Name
Hôpital Pasteur
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Hôpital Universitaire Carémeau (CHU Carémeau)
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Hôpital La Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Européen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital BICHAT- APHP
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
Country
France
Facility Name
Hôpital Haut Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Poitiers - Poitiers
City
Poitiers
Country
France
Facility Name
Hôpital Charles Nicolle- Rouen
City
Rouen
Country
France
Facility Name
Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Gisborne Hospital
City
Gisborne
Country
New Zealand
Facility Name
Nelson Hospital
City
Nelson
Country
New Zealand
Facility Name
Taranaki Hospital
City
New Plymouth
Country
New Zealand
Facility Name
Whangarei Hospital
City
Whangarei
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Limited access data (i.e., records without personal identifiers) will be prepared by the Data Coordinating Center (DCC) and sent to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) within 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first. The Trial data set will include baseline patient characteristics, follow-up status, and clinical outcome data. The data will be released to requesting institutions and investigators in accordance with BioLINCC policy.
Citations:
PubMed Identifier
23708168
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.
Results Reference
background
PubMed Identifier
27732721
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.
Results Reference
background
PubMed Identifier
34932836
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.
Results Reference
derived

Learn more about this trial

Myocardial Ischemia and Transfusion

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