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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Anemia, Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT00313716

Run by

Claudia Sue Robertson

People needed

200

Starts

2006-04-01

Expected to finish

2013-03-01

Last updated by the study team

2014-09-10

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baylor College of Medicine, Ben Taub General Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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