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| Sponsor: | Medstar Research Institute |
|---|---|
| Collaborator: |
Department of Veterans Affairs |
| Information provided by: | Medstar Research Institute |
| ClinicalTrials.gov Identifier: | NCT00126334 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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
|
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 |
Inclusion Criteria:
All of the following must be present:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Howard A Cooper, M.D. | Washington Hospital Center |
More Information
| 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 |
|
Myocardial Infarction Anemia Erythrocyte Transfusion |
|
Anemia Infarction Myocardial Infarction Hematologic Diseases Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |