Conditions: Acquired Bleeding Disorder Trauma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 554
Healthy volunteers: no

Brief summary:
This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity.

Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.

Detailed description:
The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns. The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence, the company has decided to close the trial as this juncture.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: eptacog alfa (activated) intervention 2: placebo
Intervention descriptions: intervention 1: Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection.

Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours. intervention 2: placebo

Protocol document: