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Completed

NCT Number: NCT01601457

Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

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.

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Key information

Conditions

Acquired Bleeding Disorder Trauma Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Total volume of perioperative blood loss

Secondary outcomes

  1. Volumes of intraoperative and postoperative blood loss

  2. Volume of blood transfused during the perioperative period

  3. Vital signs

  4. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
May 18, 2012
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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