Status:
UNKNOWN
Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery
Lead Sponsor:
Medtrade
Collaborating Sponsors:
The Clinical Trial Company
Conditions:
C.Surgical Procedure; Cardiac
Haemorrhage.
Eligibility:
All Genders
18+ years
Phase:
NA
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 thorac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01879475
Start Date
June 1 2013
Last Update
April 7 2015
Active Locations (1)
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1
Hull and East Yorkshire Hospitals NHS Trust
Hull, East Yorkshire, United Kingdom, HU3 2JZ