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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01639833
First received: July 11, 2012
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cardiac Surgical Procedures
Hemorrhage
Device: Veriset Hemostatic Patch
Device: TachoSil®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Time to Hemostasis (TTH) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).


Secondary Outcome Measures:
  • Hemostasis at All Treated Bleeding Sites Within 3 Minutes [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application.


Enrollment: 90
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Veriset Hemostatic Patch
Topical Hemostat
Device: Veriset Hemostatic Patch
Topical hemostat
Active Comparator: TachoSil®
Topical Hemostat
Device: TachoSil®
Topical Hemostat

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639833

Locations
Belgium
Bonheiden, Belgium
UZ Brussels
Brussels, Belgium
St Luc Hospital
Brussels, Belgium
Genk, Belgium
Hassalt, Belgium
Leuven, Belgium
Germany
Dresden, Germany
Freiburg, Germany
Hamburg, Germany
Leipzig, Germany
Munich, Germany
Latvia
Riga, Latvia
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: David Glineur, MD Clinique St-Luc Bouge, Namur, Belgium
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01639833     History of Changes
Other Study ID Numbers: COVEUCV0140
Study First Received: July 11, 2012
Results First Received: June 3, 2014
Last Updated: June 3, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014