Status:
COMPLETED
Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury
Lead Sponsor:
Claudia Sue Robertson
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Anemia
Traumatic Brain Injury
Eligibility:
All Genders
15+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine the effect of early administration of recombinant human erythropoietin on long-term neurological outcome after severe traumatic brain injury.
Detailed Description
Traumatic brain injury (TBI) causes a spectrum of cerebrovascular dysfunction, ranging from impaired pressure autoregulation to severe global ischemia (inadequate blood flow). Pressure autoregulation ...
Eligibility Criteria
Inclusion
- Blunt trauma mechanism of brain injury
- Glasgow Coma Score - motor component ≤ 5 (not following commands) on the post-resuscitation neurologic exam
- Available for enrollment and administration of study drug within 6 hours of injury
Exclusion
- Penetrating trauma (i.e. gun shot wounds)
- Glasgow Coma Score = 3 and bilateral fixed and dilated pupils
- Abbreviated Injury Scale score \> 5 for any body part except brain
- Severe pre-existing chronic disease
- Uncontrolled hypertension, defined as mean arterial pressure \> 130mmHg despite antihypertensive treatment
- Known hypersensitivity to mammalian cell-derived products or human albumin
- Currently taking anticoagulants
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00313716
Start Date
April 1 2006
End Date
March 1 2013
Last Update
September 10 2014
Active Locations (1)
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1
Baylor College of Medicine, Ben Taub General Hospital
Houston, Texas, United States, 77030