Status:
UNKNOWN
"Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery
Lead Sponsor:
Austin Health
Conditions:
Myocardial Ischemia
Blood Coagulation Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 conventio...
Detailed Description
11\. 3 Methods Synopsis of Study: A multicentred randomised, double blind, placebo-controlled trial evaluating the efficacy and safety of activated recombinant factor VII (rVIIa) in complex cardiac ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00214656
Start Date
June 1 2005
End Date
June 1 2008
Last Update
September 22 2005
Active Locations (1)
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1
Austin Health
Melbourne, Victoria, Australia, 3084