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Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

Primary Purpose

Acquired Bleeding Disorder, Trauma

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

activated recombinant human factor VII

placebo

About this trial

This is an interventional treatment trial for Acquired Bleeding Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Activated recombinant human factor VII

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Total volume of perioperative blood loss

Secondary Outcome Measures

Volumes of intraoperative and postoperative blood loss

Volume of blood transfused during the perioperative period

Vital signs

Adverse events

Full Information

NCT ID

NCT01601457

First Posted

May 16, 2012

Last Updated

January 12, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01601457

Brief Title

Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

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 Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

September 2002 (undefined)

Primary Completion Date

April 2004 (Actual)

Study Completion Date

April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acquired Bleeding Disorder, Trauma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Activated recombinant human factor VII

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

activated recombinant human factor VII

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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 Measure Information:

Title

Total volume of perioperative blood loss

Secondary Outcome Measure Information:

Title

Volumes of intraoperative and postoperative blood loss

Title

Volume of blood transfused during the perioperative period

Title

Vital signs

Title

Adverse events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

15734783

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-controlled trial. Br J Anaesth. 2005 May;94(5):586-91. doi: 10.1093/bja/aei102. Epub 2005 Feb 25.

Results Reference

result

PubMed Identifier

18580208

Citation

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.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

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Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

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