Status:
COMPLETED
Safety of Darbepoetin Alfa Treatment in Patients With Severe Traumatic Brain Injury
Lead Sponsor:
Royal Alexandra Hospital
Collaborating Sponsors:
University of Alberta
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if the treatment of severely brain injured patients with darbepoetin (a long acting form of erythropoietin) will be safe, and will reduce brain damage by decreasing...
Detailed Description
Traumatic brain injury (TBI) is a common neurosurgical problem with a high morbidity and mortality. Studies interested in defining possible therapeutic targets in TBI have led to an appreciation of tw...
Eligibility Criteria
Inclusion
- Age 18-70 inclusive.
- Admitted to ICU with a TBI and a GCS ≤ 8 with a motor score \< 6.
- Patient must have a functioning external ventricular drain in place for intracranial pressure (ICP) monitoring.
- Completion of informed consent by the next-of-kin or legal guardian.
- Randomization within 12 hours of initial triage by medical or paramedical staff.
- Abnormal CT of the brain.
Exclusion
- Pregnancy
- Cardiac arrest during the current hospital admission.
- Bilateral non-reactive dilated pupils at the time of randomization.
- A history of renal failure, NYHA class IV congestive heart failure, or recent myocardial infarction (within 6 months).
- A history of primary or secondary polycythemia.
- Previous adverse reactions to rhEPO or darbepoetin.
- Previous history of seizure disorder.
- Recent history (within the past 3 months) of significant uncontrolled hypertension defined as SBP \> 200 mm Hg or DBP \> 110 mmHg.
- Patients involved in other clinical investigations involving therapeutic interventions
- Hemoglobin ≥150 g/L in females
- Hemoglobin ≥160g/L in males
- Past history of thrombotic events
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00375869
Start Date
November 1 2006
End Date
December 1 2009
Last Update
March 5 2012
Active Locations (2)
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1
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
2
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7