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

• 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 ]
  

• 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 ]
  

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.