Conservative Versus Liberal Red Cell Transfusion in Myocardial Infarction Trial: The CRIT Pilot - NCT00126334-20010A (Clinical Trial 126317)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy126317.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Washington |
|
State:
|
|
DC |
| Zip Code: |
|
20010 |
| Conditions: |
|
Myocardial Infarction - Anemia |
| 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.
|
| Study summary: |
|
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. |
| 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 |
|
|
|
| Study is available at: |
|
Washington Hospital Center
Washington, DC 20010
United States
Primary Contact:
Howard A Cooper, MD
Email: howard.a.cooper@medstar.net
Phone: 202-877-6348
Secondary Contact:
Howard A Cooper, M.D.
Email: howard.a.cooper@medstar.net
Phone: 202-877-6348 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 15, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|