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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02981407




Registration number
NCT02981407
Ethics application status
Date submitted
1/12/2016
Date registered
5/12/2016

Titles & IDs
Public title
Myocardial Ischemia and Transfusion
Scientific title
Myocardial Ischemia and Transfusion
Secondary ID [1] 0 0
1U01HL133817-01
Secondary ID [2] 0 0
Pro20160000722
Universal Trial Number (UTN)
Trial acronym
MINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Anemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Red Blood Cell Transfusion

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.

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.


Treatment: Other: Red Blood Cell Transfusion
Transfusion of packed red blood cell units
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction
Timepoint [1] 0 0
Within 30 days of randomization
Secondary outcome [1] 0 0
All-cause Mortality
Timepoint [1] 0 0
Within 30 days of randomization
Secondary outcome [2] 0 0
Myocardial Reinfarction
Timepoint [2] 0 0
Within 30 days of randomization
Secondary outcome [3] 0 0
Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis
Timepoint [3] 0 0
Within 30 days of randomization

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/10/2023
Sample size
Target
Accrual to date
Final
3506
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Gosford
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
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Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
Country [18] 0 0
United States of America
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Pennsylvania
Country [19] 0 0
United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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Vermont
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United States of America
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Virginia
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United States of America
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Wisconsin
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Brazil
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Salvador
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Brazil
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São Paulo
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Brazil
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Belo Horizonte
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Brazil
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Brasília
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Brazil
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Campinas
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Brazil
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Cascata
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Brazil
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Centro
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Brazil
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Porto Alegre
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Brazil
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Poços De Caldas
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Brazil
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Recife
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Brazil
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São José Do Rio Preto
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Brazil
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Uberaba
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Brazil
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Uberlândia
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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France
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Chambray-lès-Tours
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France
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Chartres
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France
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Corbeil-Essonnes
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France
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Dijon
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France
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La Tronche
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France
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Lille
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France
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Montpellier
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France
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Nancy
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France
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Nice
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France
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Nîmes
Country [56] 0 0
France
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Paris
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France
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Pessac
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France
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Poitiers
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France
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Rouen
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France
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Toulouse
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New Zealand
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Auckland
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New Zealand
State/province [62] 0 0
Christchurch
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New Zealand
State/province [63] 0 0
Gisborne
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New Zealand
State/province [64] 0 0
Nelson
Country [65] 0 0
New Zealand
State/province [65] 0 0
New Plymouth
Country [66] 0 0
New Zealand
State/province [66] 0 0
Whangarei

Funding & Sponsors
Primary sponsor type
Other
Name
Rutgers, The State University of New Jersey
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Pittsburgh
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeffrey L Carson, MD
Address 0 0
Rutgers Robert Wood Johnson Medical School
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02981407