At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating activated recombinant human factor VII and placebo for Acquired Bleeding Disorder and Trauma. Completed, enrolled 283 participants across 9 sites in 9 countries.
Detailed 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.
Study Details
Timeline
Interventions
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
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