A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery

Medtronic

Status

Completed

Conditions

Hemorrhage

Cardiac Surgical Procedures

Treatments

Device: TachoSil®

Device: Veriset Hemostatic Patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT01639833

COVEUCV0140

Details and patient eligibility

About

The objective of this study is to assess the safety and effectiveness of Veriset™ Hemostatic Patch in cardiovascular procedures by comparing Veriset™ Hemostatic Patch to TachoSil® in subjects undergoing open cardiovascular surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or CABG.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has provided informed consent.
Subject is ≥18 years of age.
Subject is scheduled for surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or coronary artery bypass graft (CABG) where a topical hemostatic agent would be used to control bleeding via an open approach.
Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death.
Subject has a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin.
Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
Subject has an estimated life expectancy of less than 6 months.
Subject is unwilling to receive blood products.
Subject is scheduled for another planned cardiovascular surgery, and subsequent surgery would jeopardize previous application of study treatment.
The subject has participated in another investigational drug or device research study within 30 days of enrollment.

Exclusion criteria

Subject has an appropriate Target Bleeding Site (TBS) defined as an area of bleeding on the aorta or coronary vessels where hemostasis by conventional methods is ineffective or impractical, and thus necessitates the use of a topical hemostatic agent.
TBS Bleeding is Type 2 (Oozing/Mild) or 3 (Moderate).
It is possible to hold pressure on Veriset™ Hemostatic Patch or TachoSil® for at least 3 minutes.
Incidental finding of any other pre-operative exclusion criteria
Subject does not have an appropriate TBS.
TBS Bleeding Assessment is Type 1 (No bleeding) or 4 (Severe/Surgical/Life Threatening).
Subject has an active local infection at the surgical site.
Investigator determines that participation in the study may jeopardize the safety or welfare of the subject.