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Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

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ClinicalTrials.gov Identifier: NCT01601457
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Acquired Bleeding Disorder Trauma Drug: activated recombinant human factor VII Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2002
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Activated recombinant human factor VII 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

Placebo Comparator: Placebo 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




Primary Outcome Measures :
  1. Total volume of perioperative blood loss

Secondary Outcome Measures :
  1. Volumes of intraoperative and postoperative blood loss
  2. Volume of blood transfused during the perioperative period
  3. Vital signs
  4. Adverse events


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601457


Locations
United Kingdom
Novo Nordisk Investigational Site
London, United Kingdom
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S