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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01601457

Enrollment

Registered

2012-05-18

Start date

2002-09-30

Completion date

2004-04-30

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Bleeding Disorder, Trauma

Brief 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.

Interventions

DRUGactivated 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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Total volume of perioperative blood loss	—

Secondary

Measure	Time frame
Volumes of intraoperative and postoperative blood loss	—
Volume of blood transfused during the perioperative period	—
Vital signs	—
Adverse events	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026