Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Acquired Bleeding Disorder, Trauma

In brief

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.

Key facts

Study ID

NCT00184548

Run by

Novo Nordisk A/S

People needed

554

Starts

2005-10-01

Expected to finish

2008-09-01

Last updated by the study team

2014-06-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Novo Nordisk Clinical Trial Call Center — Princeton, New Jersey, United States
• Study site — Säo Paulo, Brazil
• Study site — Prague, Czechia
• Study site — Paris La Défense Cedex, France
• Study site — Mainz, Germany
• Study site — Vouliagment, Greece
• Study site — Kowloon, Hong Kong
• Study site — Budapest, Hungary
• Study site — Rome, Italy
• Study site — Alphen aan den Rijn, Netherlands
• Study site — Sandton, South Africa
• Study site — Madrid, Spain
• Study site — Zurich, Switzerland
• Study site — Crawley, United Kingdom

Full record on ClinicalTrials.gov

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