Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

Phase 2

Completed

• Conditions: Acquired Bleeding Disorder; Trauma
• Interventions: Drug: placebo; Drug: activated recombinant human factor VII

• Registration Number: NCT01601457
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Study First Submitted: 2012-05-16
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-18
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Activated recombinant human factor VII	activated recombinant human factor VII	-

Primary Outcome Measures

Name	Time	Method
Total volume of perioperative blood loss

Secondary Outcome Measures

Name	Time	Method
Volumes of intraoperative and postoperative blood loss
Volume of blood transfused during the perioperative period
Vital signs
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 London, United Kingdom