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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01879475
Other study ID # CT001
Secondary ID
Status Recruiting
Phase N/A
First received June 13, 2013
Last updated April 6, 2015
Start date June 2013

Study information

Verified date April 2015
Source Medtrade
Contact Sara Farmer
Phone +44 1270 500 019
Email saraandpete.farmer@virgin.net
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
032-11
Topical haemostat
Floseal (R)
Topical haemostat

Locations

Country Name City State
United Kingdom Hull and East Yorkshire Hospitals NHS Trust Hull East Yorkshire

Sponsors (2)

Lead Sponsor Collaborator
Medtrade The Clinical Trial Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Haemostasis success Proportion of patients achieving haemostasis success following the first application of compression. Intra-operative No
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