Safety of Darbepoetin Alfa Treatment in Patients With Severe Traumatic Brain Injury

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 harmful levels of chemicals in the brain.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Alexandra Hospital
• Collaborator: University of Alberta
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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