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Conservative Versus Liberal Red Cell Transfusion in Myocardial Infarction Trial: The CRIT Pilot (CRIT)

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ClinicalTrials.gov Identifier: NCT00126334
Recruitment Status : Completed
First Posted : August 3, 2005
Last Update Posted : July 21, 2011
VA Office of Research and Development
Information provided by:
Medstar Health Research Institute

Brief Summary:
The purpose of this trial is to determine whether a conservative or a liberal blood transfusion strategy is better for patients with a heart attack and a low blood count.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Anemia Procedure: Packed Red Blood Cell Transfusion Phase 4

Detailed Description:

The current standard of care for patients with heart attacks is to transfuse red blood cells when the hematocrit (red blood cell count) drops below 30 percent. However, there is little scientific basis for this current standard, and recent research has demonstrated that it is safe to allow the hematocrit (red blood cell count) to drop significantly lower in severely ill medical patients and in patients with heart disease undergoing major surgery. The investigators therefore propose this pilot trial to begin to determine whether or not it is safe to apply a more conservative blood transfusion strategy to patients with heart attacks.

In this study, patients who are within 72 hours of the onset of a heart attack and who are anemic (have a low red blood cell count) will be randomly assigned to one of two transfusion strategies while they are in the hospital: a liberal strategy of transfusing blood when the hematocrit falls below 30 percent (the current standard) or a conservative strategy of transfusing blood only when the hematocrit falls below 24 percent. It will then be determined which group fares better over the next 30 days.

The plan is to enroll 92 patients in this pilot trial in order to allow the researchers to plan for a much larger, definitive trial of this important question. It is anticipated that the conservative transfusion strategy will be similar to the standard (liberal) strategy in terms of patient outcomes.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2003
Primary Completion Date : December 2010
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Liberal transfusion threshold
Procedure: Packed Red Blood Cell Transfusion
transfusion of 1 unit of PRBCs
Experimental: 2
Conservative transfusion threshold
Procedure: Packed Red Blood Cell Transfusion
transfusion of 1 unit of PRBCs

Primary Outcome Measures :
  1. In-hospital death [ Time Frame: In-hospital ]
  2. Recurrent myocardial infarction (MI) [ Time Frame: In-hospital ]
  3. New or worsening heart failure [ Time Frame: In-hospital ]

Secondary Outcome Measures :
  1. Critical Care Unit (CCU) length of stay [ Time Frame: In-hospital ]
  2. Length of hospitalization [ Time Frame: In-hospital ]
  3. Death or recurrent MI at hospital discharge and 30 days [ Time Frame: 30 days ]
  4. Death or recurrent MI or new or worsening congestive heart failure (CHF) at 30 days [ Time Frame: 30 days ]
  5. Death at 30 days [ Time Frame: 30 days ]
  6. In-hospital recurrent ischemia [ Time Frame: In-hospital ]
  7. In-hospital death or recurrent MI or new or worsening CHF or recurrent ischemia [ Time Frame: In-hospital ]
  8. Acute renal insufficiency (increase in serum creatinine of ≥ 0.5mg/dL) [ Time Frame: In-hospitall ]
  9. Number of transfusions received per patient [ Time Frame: In-hospital ]
  10. Proportion of patients receiving at least one transfusion [ Time Frame: In-hospital ]
  11. Mean daily hematocrit [ Time Frame: In-hospital ]
  12. Transfusion-related reactions [ Time Frame: In-hospital ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

All of the following must be present:

  • Acute myocardial infarction with presentation within 72 hours of randomization (acute myocardial infarction is defined as ischemic-type chest discomfort lasting at least 30 minutes associated with creatinine kinase MB (CKMB) or troponin >upper limit of normal [ULN])
  • Admission to CCU
  • Hematocrit .30 or less
  • Written, informed consent

Exclusion Criteria:

  • Inability or unwillingness to receive red cell transfusions
  • Active bleeding (overt blood loss accompanied by a decrease in hematocrit of at least 5% in the preceding 12 hours)
  • Receipt of red cell transfusion within 7 days of randomization
  • Prior severe transfusion reaction
  • Pregnancy
  • Imminent death
  • Decision to provide limited care
  • Age <21
  • Participation in another clinical trial in which blood transfusion is a requirement or a component of a primary or secondary endpoint
  • Previous participation in the CRIT Pilot

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126334

United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Washington VA Medical Center
Washington, District of Columbia, United States, 20010
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States
Sponsors and Collaborators
Medstar Health Research Institute
VA Office of Research and Development
Principal Investigator: Howard A Cooper, M.D. Washington Hospital Center

Responsible Party: Dr. Neil Weissman, Medstar Research Institute
ClinicalTrials.gov Identifier: NCT00126334     History of Changes
Other Study ID Numbers: 2003-003
First Posted: August 3, 2005    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Medstar Health Research Institute:
Myocardial Infarction
Erythrocyte Transfusion

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases