Clinical trial NCT02164201: Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery
Official title: Post Market Surveillance Study Evaluating the Operative Management of Anastomotic Bleeding by Means of an Adjunctive Application of BioFoam Surgical Matrix in Cardiovascular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Procedures
Thoracic Aortic Aneurysm
Aortic Valve Replacement
Type A Aortic Dissection
Keywords: Type A Aortic Dissection (where the use of BioFoam is limited to the anastomotic site)
Lead sponsor: CryoLife Europa
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac or cardiovascular procedures, including, but not limited to:

Thoracic Aortic Aneurysm Aortic Valve Replacement Type A Aortic Dissection (where BioFoam is limited to the anastomotic site)

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.


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).

Primary outcomes:
measure: Achievement of haemostasis
timeFrame: 3 minutes after application
Secondary outcomes:
measure: Time to haemostasis
timeFrame: measured through to 10 minutes
Other outcomes:
Locations:
city: Munich
country: Germany
facility: German Heart Center
city: Milan
country: Italy
facility: San Raffale Hospital
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Bernhard Voss, PD Dr Med
role: PRINCIPAL_INVESTIGATOR
affiliation: San Raffale Hospital
name: Ottavio Alfieri, Professor
role: PRINCIPAL_INVESTIGATOR
References: