NCT01601457

Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

A Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Efficacy and Safety of Activated Recombinant Coagulation Factor VII (rFVIIa, NovoSeven®) in Patients With Major Fractures of Pelvis or Pelvis and Acetabulum Undergoing Repair Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Bleeding Disorder
• Trauma

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII	90 mcg/kg body weight administered intravenously as a slow, bolus injection after the patients had been anaesthetised and immediately before the first skin incision. A second dose was given if an intraoperative haemoglobin was less than 8.0 g/dl after salvaged red cells (RBC) had been re-transfused
DRUG	placebo	Administered intravenously as a slow, bolus injection after the patients had been anaesthetised and immediately before the first skin incision. A second dose was given if an intraoperative haemoglobin was less than 8.0 g/dl after salvaged red cells (RBC) had been re-transfused

Timeline

• Start date: 2002-09-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2012-05-18
• Last updated: 2017-01-13

Locations

1 site across 1 country: United Kingdom