Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery
Not Applicable
- Conditions
- Haemorrhage.C.Surgical Procedure; Cardiac
- Registration Number
- NCT01879475
- Lead Sponsor
- Medtrade
- Brief Summary
The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- The patient must be equal or greater than 18 years old
- The patient must have elective or non-elective urgent cardiac surgery or thoracic aortic surgery
- The patient must have no childbearing potential or have a negative serum or urine pregnancy test within 7 days of the planned surgery or in the opinion of the Investigator performs adequate contraception
- The patient is willing and able to be contacted for the follow-up visit at 6- 8 weeks
- The patient must provide written informed consent using a form that is reviewed and approved by the IEC
Exclusion Criteria
- The patient is currently enrolled in this or another investigational device or drug trial that has not completed the required follow up period.
- The patient has a known hypersensitivity to materials of bovine origin
- The patient does not wish to receive materials of bovine or shellfish origin for any reason
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Haemostasis success Intra-operative Proportion of patients achieving haemostasis success following the first application of compression.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hull and East Yorkshire Hospitals NHS Trust
🇬🇧Hull, East Yorkshire, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust🇬🇧Hull, East Yorkshire, United KingdomMahmoud Loubani, FRCSPrincipal Investigator