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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Cardiac Surgical Procedures
• Intervention / Treatment: Device: Veriset Hemostatic Patch; Device: TachoSil®

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium
  • Brussels, Belgium
    • UZ Brussels
  • Brussels, Belgium
    • St Luc Hospital
  • Genk, Belgium
  • Hassalt, Belgium
  • Leuven, Belgium
• Germany
  • Dresden, Germany
  • Freiburg, Germany
  • Hamburg, Germany
  • Leipzig, Germany
  • Munich, Germany
• Latvia
  • Riga, Latvia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Veriset Hemostatic Patch; Topical Hemostat	Device: Veriset Hemostatic Patch; Topical hemostat
Active Comparator: TachoSil®; Topical Hemostat	Device: TachoSil®; Topical Hemostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Hemostasis (TTH)	Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostasis at All Treated Bleeding Sites Within 3 Minutes	The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application.	Day 0

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: David Glineur, MD, Clinique St-Luc Bouge, Namur, Belgium

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimate): July 13, 2012

Study Record Updates

• Last Update Posted (Estimate): July 3, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: COVEUCV0140