Myocardial Ischemia and Transfusion (MINT)

This study has been completed.
Sponsor:
Collaborators:
University of Pittsburgh
Albert Einstein College of Medicine of Yeshiva University
Brigham and Women's Hospital
Rhode Island Hospital
Information provided by (Responsible Party):
rwjmsmedicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01167582
First received: March 17, 2010
Last updated: August 14, 2014
Last verified: August 2014
Results First Received: August 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Myocardial Infarction
Unstable Angina
Coronary Artery Disease
Intervention: Biological: Red blood cell transfusion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Liberal Transfusion Strategy Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood 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. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL.
Restrictive Transfusion Strategy

Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL.

Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension.


Participant Flow:   Overall Study
    Liberal Transfusion Strategy     Restrictive Transfusion Strategy  
STARTED     55     55  
COMPLETED     55     54  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized patients

Reporting Groups
  Description
Liberal Transfusion Strategy Patients receive red blood cell transfusion 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
Restrictive Transfusion Strategy Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
Total Total of all reporting groups

Baseline Measures
    Liberal Transfusion Strategy     Restrictive Transfusion Strategy     Total  
Number of Participants  
[units: participants]
  55     55     110  
Age  
[units: years]
Mean ± Standard Deviation
  67.3  ± 13.6     74.3  ± 11.1     70.8  ± 12.8  
Gender  
[units: participants]
     
Female     27     28     55  
Male     28     27     55  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hemoglobin Concentration   [ Time Frame: In-hospital up to 30 days post randomization ]

2.  Primary:   Red Blood Cell Transfusion   [ Time Frame: In-hospital up to 30 days post randomization ]

3.  Secondary:   Mortality or Myocardial Ischemia   [ Time Frame: 30 days ]

4.  Secondary:   Mortality or Myocardial Ischemia   [ Time Frame: 6 months ]

5.  Primary:   Trial Feasibility   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Individual Components of Composite Outcome   [ Time Frame: 30 days and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Mortality From Cardiac Causes   [ Time Frame: 30 days and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Unscheduled Hospital Admission   [ Time Frame: 30 days and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Stroke   [ Time Frame: 30 days and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Congestive Heart Failure   [ Time Frame: 30 days and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Stent Thrombosis   [ Time Frame: 30 days and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Deep Vein Thrombosis and Pulmonary Embolism   [ Time Frame: 30 days and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Pneumonia or Blood Stream Infection and Each Separately   [ Time Frame: 30 days and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Composite Mortality and Morbidity   [ Time Frame: 30 days and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This pilot trial was not designed to enroll enough patients to answer the transfusion dilemma currently facing clinicians in practice.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeffrey Carson
Organization: Rutgers University
phone: 732-235-7122
e-mail: jeffrey.carson@rutgers.edu


Publications of Results:

Responsible Party: rwjmsmedicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01167582     History of Changes
Other Study ID Numbers: 0220090205, 1RC2HL101458-01
Study First Received: March 17, 2010
Results First Received: August 14, 2014
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board