Post Market Surveillance Study Evaluating the Operative Management of Anastomotic Bleeding by Means of an Adjunctive Application of BioFoam Surgical Matrix in Cardiovascular Surgery

CryoLife Europa2 sites in 2 countries75 target enrollmentAugust 2014

ConditionsCardiovascular Procedures Thoracic Aortic Aneurysm Aortic Valve Replacement Type A Aortic Dissection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiovascular Procedures
Sponsor: CryoLife Europa
Enrollment: 75
Locations: 2
Primary Endpoint: Achievement of haemostasis
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery.

The overall objective of this clinical study is to collect clinical data supporting the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. This study is intended as a post-market surveillance (follow-up) study.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

July 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

CryoLife Europa

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is undergoing an elective cardiac or cardiovascular procedure;
•Subject is willing and able to give prior written informed consent for investigation participation; and
•Subject is \> 18 years of age.
•Intraoperative inclusion criteria include:
•Subject that requires the use of an adjunctive surgical hemostatic agent to the repair site to control generalized oozing following standard repair procedures (such as sutures and staples).

Exclusion Criteria

•• Subject with known hypersensitivity to albumin, bovine products, or glutaraldehyde;
•Subject with active infection (either systemic or in the repair region);
•Subject whose pathology or underlying disease state makes them an unacceptable candidate for a clinical investigation in the opinion of the Investigator;
•Subject diagnosed with a coagulation disorder;
•Subject with abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism);
•Subject whose life expectancy is less than that required for the prescribed follow-up duration;
•Subject who is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; or
•Subject who is immunocompromised.
•Intraoperative exclusion criteria include:
•Any major intraoperative bleeding incidences (i.e., American College of Surgeons Advanced Trauma Life Support Class II, III, or IV Hemorrhage).