Phase 3
N=200
Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury
Anemia · Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT00313716 ↗Enrolled (actual)
200
Serious AEs
83.8%
Results posted
Sep 2014
Primary outcome: Primary: Glasgow Outcome Scale — 17; 17; 34; 37 participants — p=.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- recombinant human erythropoietin, rhEpo (Drug); placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Claudia Sue Robertson
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glasgow Outcome Scale |
17; 17; 34; 37; 31; 18 | .01 sig |
| SECONDARY Disability Rating Scale |
5; 8 | .06 |
| SECONDARY Mortality Rate |
6; 7; 18; 14; 17; 32 | .25 |
| SECONDARY Incidence of Adult Respiratory Distress Syndrome (ARDS) |
16; 25; 83; 76 | .08 |
| SECONDARY Incidence of Infection |
27; 36; 72; 65 | .26 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00313716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.