Grant: $120,000 - National Institutes of Health - Sep. 7, 2009
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Award Description: The purpose of the funding is to increase enrollment in a clinical trial of erythropoietin in TBI patients (Projects 1 and 2), and to purchase equipment for Project 3. Projects 1 and 2 of our grant are a clinical trial of 200 severe TI patients. The goal of the study is to determine if early treatment with erythropoietin will improve outcome and cerebral hemodynamics after TBI, and to determine the optimal hemoglobin concentration to maintain in a TBI patient. The trial is a 2x2 factorial design with randomizations to erythropoietin vs placebo and to a hemoglobin transfusion threshold of 7gm/dl vs 10gj/dl. The trial began in May 2006, and was on track to complete enrollment by the end of the funding period for the grant (1/31/2011) when in Sept. 2008, the FDA placed a full clinical hold on the study. The hold was because of safety concerns that arose in another unrelated clinical trial in stroke patients, and not because of any concerns with our trial. We were able to get the clinical hold lifted from our trial on Feb. 25, 2008 by demontrating to the FDA that the stroke trial results were not relevant to our study. We are now restarting enrollment in our trial. We are requesting administrative supplement funds for a second study site at Memorial Hermman Hospital, UTHSC-Houston with Alex Valadka as the PI. The funds would be for Dr. Valadka, Dr. IMoigele Aisiku (co-investigator), and for a research coordinator plus patient care costs for approximately 25 patients/year for FY2009 and FY2010. With the 40-50 patients/year expected to be enrolled at Ben Taub General Hospital, the supplemental funding should allow us to be able to complete the study more rapidly. We are also asking for funds to replace our transcranial Doppler equipment, which is no longer working, and for funds for additional community notification which the FDA has required us to do prior to enrolling patients again under the emergency consent exception. These requests meet the Recovery Act funding by providing an additional position for a research coordinator and purchase of equipment. This funding should significantly increase the speed of completing our clinical trial of erythropoietin.
Project Description: As defined in the Award Description field
Jobs Summary: N/A (Total jobs reported: 0)
Project Status: Not Started
This award's data was last updated on Sep. 7, 2009. Help expand these official descriptions using the wiki below.