NCT01639833

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
3 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 3, 2014

Completed
Last Updated

July 3, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

July 11, 2012

Results QC Date

June 3, 2014

Last Update Submit

June 3, 2014

Conditions

Cardiac Surgical ProceduresHemorrhage

Outcome Measures

Primary Outcomes (1)

  • Time to Hemostasis (TTH)

    Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).

    Day 0

Secondary Outcomes (1)

  • Hemostasis at All Treated Bleeding Sites Within 3 Minutes

    Day 0

Study Arms (2)

Veriset Hemostatic Patch

EXPERIMENTAL

Topical Hemostat

Device: Veriset Hemostatic Patch

TachoSil®

ACTIVE COMPARATOR

Topical Hemostat

Device: TachoSil®

Interventions

Veriset Hemostatic PatchDEVICE

Topical hemostat

Veriset Hemostatic Patch
TachoSil®DEVICE

Topical Hemostat

TachoSil®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Bonheiden, Belgium

Location

St Luc Hospital

Brussels, Belgium

Location

UZ Brussels

Brussels, Belgium

Location

Unknown Facility

Genk, Belgium

Location

Unknown Facility

Hassalt, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Freiburg im Breisgau, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Leipzig, Germany

Location

Unknown Facility

Munich, Germany

Location

Unknown Facility

Riga, Latvia

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Michael Rohan
Organization
Covidien
Michael.Rohan@Covidien.com
781-839-1757

Study Officials

  • David Glineur, MD

    Clinique St-Luc Bouge, Namur, Belgium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 13, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 3, 2014

Results First Posted

July 3, 2014

Record last verified: 2014-06

Locations

DE(5)LA(1)BE(6)