Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

Trauma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601457
• Other study ID #: F7ORTHO-1506
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2012
• Last updated: January 12, 2017
• Start date: September 2002
• Est. completion date: April 2004

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Blood Coagulation Disorders
• Hemostatic Disorders
• Trauma

Intervention

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
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

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec. — View Citation

Raobaikady R, Redman J, Ball JA, Maloney G, Grounds RM. Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-contro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total volume of perioperative blood loss
Secondary	Volumes of intraoperative and postoperative blood loss
Secondary	Volume of blood transfused during the perioperative period
Secondary	Vital signs
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk