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