Princeton, New Jersey 08540

  • Trauma

Purpose:

This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII 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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00184548


Primary Contact:

Study Director
Bartholomew Tortella, MD
Novo Nordisk


Backup Contact:

N/A


Location Contact:

Princeton, New Jersey 08540
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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