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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

July 11, 2012
June 3, 2014
August 2012
December 2013   (final data collection date for primary outcome measure)
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).
Time to Hemostasis (TTH) [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).
Complete list of historical versions of study NCT01639833 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Cardiac Surgical Procedures
  • Hemorrhage
  • Device: Veriset Hemostatic Patch
    Topical hemostat
  • Device: TachoSil®
    Topical Hemostat
  • Experimental: Veriset Hemostatic Patch
    Topical Hemostat
    Intervention: Device: Veriset Hemostatic Patch
  • Active Comparator: TachoSil®
    Topical Hemostat
    Intervention: Device: TachoSil®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Latvia
 
NCT01639833
COVEUCV0140
Yes
Covidien
Covidien
Not Provided
Principal Investigator: David Glineur, MD Clinique St-Luc Bouge, Namur, Belgium
Covidien
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP