"Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery

• Status: Unknown status
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Austin Health

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