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

Myocardial Infarction Clinical Trial

— CRIT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126334
• Other study ID #: 2003-003
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2005
• Last updated: July 20, 2011
• Start date: April 2003
• Est. completion date: January 2011

Study information

• Verified date: July 2011
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Packed Red Blood Cell Transfusion
transfusion of 1 unit of PRBCs

Locations

Country	Name	City	State
United States	Durham VA Medical Center	Durham	North Carolina
United States	Washington Hospital Center	Washington	District of Columbia
United States	Washington VA Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Research Institute	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital death		In-hospital	Yes
Primary	Recurrent myocardial infarction (MI)		In-hospital	Yes
Primary	New or worsening heart failure		In-hospital	Yes
Secondary	Critical Care Unit (CCU) length of stay		In-hospital	Yes
Secondary	Length of hospitalization		In-hospital	Yes
Secondary	Death or recurrent MI at hospital discharge and 30 days		30 days	Yes
Secondary	Death or recurrent MI or new or worsening congestive heart failure (CHF) at 30 days		30 days	Yes
Secondary	Death at 30 days		30 days	Yes
Secondary	In-hospital recurrent ischemia		In-hospital	Yes
Secondary	In-hospital death or recurrent MI or new or worsening CHF or recurrent ischemia		In-hospital	Yes
Secondary	Acute renal insufficiency (increase in serum creatinine of = 0.5mg/dL)		In-hospitall	Yes
Secondary	Number of transfusions received per patient		In-hospital	Yes
Secondary	Proportion of patients receiving at least one transfusion		In-hospital	Yes
Secondary	Mean daily hematocrit		In-hospital	Yes
Secondary	Transfusion-related reactions		In-hospital	Yes