Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
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.
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.
Inclusion Criteria:

 -  Trauma injury (blunt and/or penetrating) with evidence of active hemorrhage (torso
 and/or proximal lower extremity) refractory to blood component therapy and surgical
 haemostatic procedures at the time of randomisation