A Randomised Controlled Trial to Compare Administration of Prothrombin Complex Concentrate with Standard Haemostasis Management in Adult Patients Undergoing Peritoneal Cytoreductive Surgery Requiring Massive Transfusion.
Phase 3
Completed
- Conditions
- Patients undergoing peritoneal cytoreductive surgeryPeritoneal cancerSurgery - Other surgeryCancer - Ovarian and primary peritoneal
- Registration Number
- ACTRN12612001002875
- Lead Sponsor
- St George Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1.Age greater than or equal to 18 years
2.Planned for peritonectomy
3.Informed consent
Exclusion Criteria
1.Known bleeding disorder
2.Known requirement for anti-coagulation e.g. prior DVT/PE requiring anti-coagulation, requirement for caval filter
3.Known hypersensitivity to any pooled-blood or recombinant blood products
4.Known hypersensitivity to any constituents in Prothrombinex-VF, including know allergy to heparin or a history of heparin-induced thrombocytopenia
5. Evidence of active thrombosis or disseminated intravascular coagulation (DIC)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of Prothrombinex in achieving haemostasis compared to standard treatment. Achievement of haemostasis shall be defined as stable haematocrit and no increase in drain losses with blood.[24 hours post surgery];Reduction in the number of units of blood products transfused in the first 24 hours, including the time of surgery.[24 hours post surgery]
- Secondary Outcome Measures
Name Time Method Measured blood loss and other fluid loss (cell saver, etc). This will be assessed by visual assessment.[24 hours post surgery];Volume of other fluids received[During surgery];Requirement for take-back to operating theatre (OT) to control bleeding within 7 days of surgery[Within 7 days of surgery];Thrombotic events to be recorded as adverse events[Within 7 days of surgery]