Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

Novo Nordisk A/S48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acquired Bleeding Disorder Trauma

Interventions

activated recombinant human factor VIIDRUG

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

placeboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

London, United Kingdom

Outcomes

Primary Outcomes

Total volume of perioperative blood loss

Secondary Outcomes

Volumes of intraoperative and postoperative blood loss

Volume of blood transfused during the perioperative period

Vital signs

Adverse events

Data from ClinicalTrials.gov

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