NCT00214656

Brief Summary

Aims and Hypotheses: This randomised placebo controlled study will test the hypothesis that Recombinant Activated Factor VII (rVIIa) will improve haemostasis after an inadequate response to conventional therapy in complex cardiac surgery. Major bleeding is still of concern in complex cardiac surgery. It has been shown to be associated with poorer patient outcome and results in the consumption of resources (hospital costs, manpower and blood bank reserves). This study has the potential to provide evidence that rVIIa can reduce transfusion requirements and improve patient outcome in a problematic aspect of complicated cardiac surgery. The objective is to conduct a multi-centre randomised placebo controlled study that has been designed to scientifically evaluate the treatment of post bypass coagulopathy in the association with complex cardiac surgery. The trial design is based on clinical practice that has evolved over 2 years at the Austin Hospital during which 38 patients have received open label administration of rVIIa. There is currently no published RCT in this area and there is no TGA approval for the use of rVIIa for this indication.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 22, 2005

Status Verified

September 1, 2005

First QC Date

September 14, 2005

Last Update Submit

September 14, 2005

Conditions

Myocardial IschemiaBlood Coagulation DisordersCoronary Artery DiseaseHeart Valve Diseases

Keywords

Cardiac surgical proceduresSurgical blood lossSurgical haemostasisFactor VIIaAnaesthesia

Outcome Measures

Primary Outcomes (1)

  • Adequate haemostasis to enable chest closure after administration of trial medication without the need for further intervention to improve coagulation.

Secondary Outcomes (10)

  • Percentage of cases that haemostasis after first administration of coagulation factors alone

  • Assessment of surgical field after administration of trial medication

  • Time to closure of chest after administration of trial medication

  • Transfusion requirements in post bypass period in theatre

  • Transfusion requirements in ICU first 12 hours

  • +5 more secondary outcomes

Interventions

Recombinant Activated Factor VIIDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with scheduled cardiac surgery undergoing the following procedures
  • Double valve replacements or repair.
  • Major thoracic aortic surgery including hypothermic circulatory arrest or descending aortic reconstruction.
  • Valve repair or replacement in the setting of endocarditis
  • Complex procedures requiring cardiopulmonary bypass duration anticipated to exceed 180 minutes in patients aged ³70 years

You may not qualify if:

  • Patient unable to give informed consent
  • Patient refusal
  • Allergy to rVIIa
  • Allergy to aprotinin or prior exposure within 6 months
  • Pre-existing congenital coagulopathy
  • Pre-existing hypercoagulable state
  • Unresolved surgical bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Health

Melbourne, Victoria, 3084, Australia

RECRUITING

Related Publications (1)

  • Hedner U, Erhardtsen E. Potential role for rFVIIa in transfusion medicine. Transfusion. 2002 Jan;42(1):114-24. doi: 10.1046/j.1537-2995.2002.00017.x. No abstract available.

    PMID: 11896322BACKGROUND

MeSH Terms

Conditions

Myocardial IschemiaBlood Coagulation DisordersCoronary Artery DiseaseHeart Valve DiseasesBlood Loss, Surgical

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Study Officials

  • Peter McCall, FANZCA

    Staff Anaesthetist

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter McCall, FANZCA

CONTACT

61 3 94965000peter.mccall@austin.org.au

stephanie j Poustie, MPH

CONTACT

61 3 94965000stephanie.poustie@austin.org.au

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

June 1, 2005

Study Completion

June 1, 2008

Last Updated

September 22, 2005

Record last verified: 2005-09

Locations

AU(1)