NCT01563523

Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients

A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ Niastase®) in the Treatment of Bleeding in Severely Injured Trauma Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Africa, Asia, Europe, Oceania and North America. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII given in conjunction with standard therapy in the treatment of massive bleeding in subjects with severe blunt and/or penetrating trauma injury.

Conditions

• Acquired Bleeding Disorder
• Trauma

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII	Standard therapy in conjunction with three single doses of rFVIIa administered over a 3 hour period. Administered once the subject has received 8 units of PRBC
DRUG	placebo	Standard therapy in conjunction with three single doses of placebo administered over a 3 hour period. Administered once the subject has received 8 units of PRBC

Timeline

• Start date: 2002-03-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2012-03-27
• Last updated: 2017-01-13

Locations

9 sites across 9 countries: Australia, Austria, Canada, France, Germany, Israel, Singapore, South Africa, United Kingdom