Overview

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

Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Claudia Sue Robertson
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Treatments:
Epoetin Alfa
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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