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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00126334
First received: August 2, 2005
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Myocardial Infarction
Anemia
Procedure: Packed Red Blood Cell Transfusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • In-hospital death [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
  • Recurrent myocardial infarction (MI) [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
  • New or worsening heart failure [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Critical Care Unit (CCU) length of stay [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
  • Length of hospitalization [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
  • Death or recurrent MI at hospital discharge and 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Death or recurrent MI or new or worsening congestive heart failure (CHF) at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Death at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • In-hospital recurrent ischemia [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
  • In-hospital death or recurrent MI or new or worsening CHF or recurrent ischemia [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
  • Acute renal insufficiency (increase in serum creatinine of ≥ 0.5mg/dL) [ Time Frame: In-hospitall ] [ Designated as safety issue: Yes ]
  • Number of transfusions received per patient [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
  • Proportion of patients receiving at least one transfusion [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
  • Mean daily hematocrit [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]
  • Transfusion-related reactions [ Time Frame: In-hospital ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: April 2003
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126334

Locations
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 Research Institute
Investigators
Principal Investigator: Howard A Cooper, M.D. Washington Hospital Center
  More Information

No publications provided

Responsible Party: Dr. Neil Weissman, Medstar Research Institute
ClinicalTrials.gov Identifier: NCT00126334     History of Changes
Other Study ID Numbers: 2003-003
Study First Received: August 2, 2005
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 22, 2014