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About
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.
Full 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.
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Inclusion and exclusion criteria
Inclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
554 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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