Status:
TERMINATED
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Acquired Bleeding Disorder
Trauma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 patien...
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 reachin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT00184548
Start Date
October 1 2005
End Date
September 1 2008
Last Update
June 25 2014
Active Locations (14)
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1
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
2
Säo Paulo, Brazil, 05001-400
3
Prague, Czechia, 16000
4
Paris La Défense Cedex, France, 92932