"Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery
Recruitment status was: Recruiting
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.
Blood Coagulation Disorders
Coronary Artery Disease
Heart Valve Diseases
Drug: Recombinant Activated Factor VII
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- Adequate haemostasis to enable chest closure after administration of trial medication without the need for further intervention to improve coagulation.
- 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
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||June 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214656
|Melbourne, Victoria, Australia, 3084|
|Principal Investigator:||Peter McCall, FANZCA||Staff Anaesthetist|