Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

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