Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Trauma; Acquired Bleeding Disorder

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01601457

F7ORTHO-1506

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VIIgiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular fractures.

Enrollment: 48 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Injury due to a blunt or penetrating trauma causing pelvic or pelvic and acetabular fracture amenable to surgical reconstruction
• Scheduled for a semi-elective reconstruction surgery for fracture(s) of pelvis or pelvis and acetabulum, which was expected to be a "large" complex procedure with the potential of blood loss more than 50% of circulating blood volume

Exclusion criteria

• A history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis)
• Patients with severe head injuries or an abnormal computed tomography (CT) scan of the head due to head injuries
• Body weight exceeding 135 kg
• Cardiac arrest following trauma and prior to surgery
• Known congenital bleeding disorders
• Known pregnancy or positive pregnancy test at enrolment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 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