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Myocardial Ischemia and Transfusion Pilot (MINT Pilot)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167582
First Posted: July 22, 2010
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
Albert Einstein College of Medicine, Inc.
Brigham and Women's Hospital
Rhode Island Hospital
Information provided by (Responsible Party):
Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
Results First Submitted: August 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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 
Overall Participants Analyzed 
[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]
Count of Participants
     
Female      27  49.1%      28  50.9%      55  50.0% 
Male      28  50.9%      27  49.1%      55  50.0% 


  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.  

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

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

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

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

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

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

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.  

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.  

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


  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: Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01167582     History of Changes
Other Study ID Numbers: 0220090205
1RC2HL101458-01 ( U.S. NIH Grant/Contract )
First Submitted: March 17, 2010
First Posted: July 22, 2010
Results First Submitted: August 14, 2014
Results First Posted: August 28, 2014
Last Update Posted: January 13, 2017