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

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.

Inclusion Criteria:

• Informed consent obtained from the subject and/or his/her legally authorised representative (LAR) before any trial-related activities
• Injury(ies) due to a blunt and or penetrating trauma
• Receipt of 6 units of PRBC within a 4 hour period following admittance to the trauma centre
• Receipt of 8 units of PRBC upon administration of trial drug

Exclusion Criteria:

• Prehospital cardiac arrest
• Cardiac arrest in the ER or OR
• Gunshot wound to the head
• Glasgow Coma Scale below 8
• Base deficit of above 15 mEq/l or severe acidosis
• Transfusion of 8 units or more of PRBC prior to arrival in trauma centre