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

PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Traumatic Brain Injury
Interventions
DRUG

Darbeopoetin

The treatment group, comprised of ten patients, will receive an intravenous dose of 200 mcg (1 ml) of darbepoetin (Aranesp®). Patients will be randomly assigned to either the treatment group, or the control group in a 2:1 ratio. The treatment group will be given 200 mcg of darbepoetin intravenously. The control group will be given a matching placebo of 1 mL of normal saline.

DRUG

Normal Saline (Placebo)

The treatment group, comprised of ten patients, will receive an intravenous dose of 200 mcg (1 ml) of darbepoetin (Aranesp®). Patients will be randomly assigned to either the treatment group, or the control group in a 2:1 ratio. The treatment group will be given 200 mcg of darbepoetin intravenously. The control group will be given a matching placebo of 1 mL of normal saline.

Trial Locations (2)

T5H 3V9

Royal Alexandra Hospital, Edmonton

T6G 2B7

University of Alberta Hospital, Edmonton

All Listed Sponsors
collaborator

University of Alberta

OTHER

lead

Royal Alexandra Hospital

OTHER

NCT00375869 - Safety of Darbepoetin Alfa Treatment in Patients With Severe Traumatic Brain Injury | Biotech Hunter | Biotech Hunter