Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
AnemiaTraumatic Brain Injury
Interventions
DRUG

recombinant human erythropoietin, rhEpo

The study design is 2x2 factorial with randomization to erythropoietin or placebo and to transfusion trigger 10 gm/dl or 7 g/dl. Erythropoietin or placebo was initially dosed daily for 3 days and then weekly for 2 more weeks (first 74 patients, Epo1 dosing regimen), and then the 24- and 48-hour doses were stopped for the remainder of the patients (remaining 126 patients, Epo2 dosing regimen).

OTHER

placebo

an inactive substance

Trial Locations (1)

77030

Baylor College of Medicine, Ben Taub General Hospital, Houston

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

Claudia Sue Robertson

OTHER

NCT00313716 - Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury | Biotech Hunter | Biotech Hunter