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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Trauma; Acquired Bleeding Disorder

Treatments: Drug: activated recombinant human factor VII; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563523

F7TRAUMA-2159

Details and patient eligibility

About

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.

Enrollment: 283 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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283 participants in 2 patient groups, including a placebo group

Activated recombinant human factor VII

Experimental group

Treatment:

Drug: activated recombinant human factor VII

Placebo

Placebo Comparator group

Treatment:

Drug: placebo