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

Medtrade

Status: Unknown

Conditions: C.Surgical Procedure; Cardiac; Haemorrhage.

Treatments: Device: 032-11; Device: Floseal (R)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01879475

CT001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

032-11

Experimental group

Description:

032-11 topical haemostat.

Treatment:

Device: 032-11

Floseal (R)

Active Comparator group

Description:

Floseal(R) topical haemostat

Treatment:

Device: Floseal (R)