NCT01601457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

May 16, 2012

Last Update Submit

January 12, 2017

Conditions

Acquired Bleeding DisorderTrauma

Outcome Measures

Primary Outcomes (1)

  • Total volume of perioperative blood loss

Secondary Outcomes (4)

  • Volumes of intraoperative and postoperative blood loss

  • Volume of blood transfused during the perioperative period

  • Vital signs

  • Adverse events

Study Arms (2)

Activated recombinant human factor VII

EXPERIMENTAL
Drug: activated recombinant human factor VII

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

activated recombinant human factor VIIDRUG

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

Activated recombinant human factor VII
placeboDRUG

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

London, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 15734783RESULT

  • 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.

    PMID: 18580208RESULT

Related Links

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 18, 2012

Study Start

September 1, 2002

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

GB(1)