Clinical trial NCT00126334: Conservative Versus Liberal Red Cell Transfusion in Myocardial Infarction Trial: The CRIT Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Anemia
Keywords: Myocardial Infarction
Anemia
Erythrocyte Transfusion
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2005-08-03
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: In-hospital death
timeFrame: In-hospital
measure: Recurrent myocardial infarction (MI)
timeFrame: In-hospital
measure: New or worsening heart failure
timeFrame: In-hospital
Secondary outcomes:
measure: Critical Care Unit (CCU) length of stay
timeFrame: In-hospital
measure: Length of hospitalization
timeFrame: In-hospital
measure: Death or recurrent MI at hospital discharge and 30 days
timeFrame: 30 days
measure: Death or recurrent MI or new or worsening congestive heart failure (CHF) at 30 days
timeFrame: 30 days
measure: Death at 30 days
timeFrame: 30 days
measure: In-hospital recurrent ischemia
timeFrame: In-hospital
measure: In-hospital death or recurrent MI or new or worsening CHF or recurrent ischemia
timeFrame: In-hospital
measure: Acute renal insufficiency (increase in serum creatinine of ≥ 0.5mg/dL)
timeFrame: In-hospitall
measure: Number of transfusions received per patient
timeFrame: In-hospital
measure: Proportion of patients receiving at least one transfusion
timeFrame: In-hospital
measure: Mean daily hematocrit
timeFrame: In-hospital
measure: Transfusion-related reactions
timeFrame: In-hospital
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Washington VA Medical Center
state: District of Columbia
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
Study officials:
affiliation: Medstar Health Research Institute
name: Howard A Cooper, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.