"Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery
Status:
Unknown status
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
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.