Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 30, 2002

Primary Completion Date

April 30, 2004

Study Completion Date

April 30, 2004

Conditions
Acquired Bleeding DisorderTrauma
Interventions
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

Trial Locations (1)

Unknown

Novo Nordisk Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY