"Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery - Full Text View

Purpose

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.

Condition	Intervention	Phase
Myocardial Ischemia Blood Coagulation Disorders Coronary Artery Disease Heart Valve Diseases	Drug: Recombinant Activated Factor VII	Phase III

Genetics Home Reference related topics:

hemophilia

MedlinePlus related topics:

Bleeding Disorders Blood Transfusion and Donation Coronary Artery Disease Heart Valve Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	"Salvage Use" of Recombinant Activated Factor VII After Inadequate Haemostatic Response to Conventional Therapy in Complex Cardiac Surgery - a Randomised Placebo Controlled Trial

Further study details as provided by Austin Health:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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
Mediastinal drainage in ICU first 12 hours
Coagulation study results at various sample times
Requirement for chest re-exploration
Ventilation duration in ICU
Duration of stay in ICU

Estimated Enrollment:	40
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2008

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Patients in inclusion criteria whose actual bypass time does not exceed 180 minutes
Unresolved surgical bleeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214656

Contacts


Contact: Peter McCall, FANZCA	61 3 94965000 ext 3800	peter.mccall@austin.org.au

Contact: stephanie j Poustie, MPH	61 3 94965000 ext 3800	stephanie.poustie@austin.org.au

Locations


Australia, Victoria
	Austin Health	Recruiting
	Melbourne, Victoria, Australia, 3084
	Contact: Peter McCall, FANZCA 61 3 94965000 ext 3800 peter.mccall@austin.org.au
	Contact: Stephanie J Poustie, MPH 61 3 94965000 ext 3800 stephanie.poustie@austin.org.au
	Principal Investigator: Peter McCall, FANZCA

Sponsors and Collaborators

Austin Health

Investigators


Principal Investigator:	Peter McCall, FANZCA	Staff Anaesthetist

More Information

Publications:

Hedner U, Erhardtsen E. Potential role for rFVIIa in transfusion medicine. Transfusion. 2002 Jan;42(1):114-24. Review. No abstract available.

Study ID Numbers:	H2005/02047
First Received:	September 14, 2005
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00214656
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by Austin Health:

Cardiac surgical procedures

Surgical blood loss

Surgical haemostasis

Factor VIIa

Anaesthesia

Study placed in the following topic categories:

Arterial Occlusive Diseases

Heart Diseases

Hematologic Diseases

Myocardial Ischemia

Blood Coagulation Disorders

Vascular Diseases

Blood Loss, Surgical

Arteriosclerosis

Ischemia

Hemostatic Disorders

Hemorrhage

Heart Valve Diseases

Coronary Disease

Hemorrhagic Disorders

Coronary Artery Disease

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 04, 2008

Sponsored by:	Austin Health
Information provided by:	Austin Health
ClinicalTrials.gov Identifier:	NCT00214656