Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery

C.Surgical Procedure; Cardiac Clinical Trial

Official title:

Prospective, Randomised, Controlled Investigation Comparing the Safety and Performance of 032-11 Surgical Haemostat With FLOSEAL® Haemostatic Matrix in Cardiac Surgery and Thoracic Aortic Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01879475
• Other study ID #: CT001
• 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. 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

• C.Surgical Procedure; Cardiac
• Haemorrhage.

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