Cardiac Surgical ProceduresNCT01639833

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 study testing Veriset Hemostatic Patch and TachoSil® in people with Cardiac Surgical Procedures and Hemorrhage, run by Medtronic - MITG at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Surgical Procedures, Hemorrhage
What is being tested?: Veriset Hemostatic Patch and TachoSil®
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 12 sitesin 3 countries
Study dates: Aug 2012to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

Trial locations and contacts

12 sites in 3 countries.

Country

City, postcode or hospital

12 sites in 3 countries

Belgium6 sites

Study site
Bonheiden
St Luc Hospital
Brussels
UZ Brussels
Brussels
Study site
Genk
Study site
Hassalt
Study site
Leuven

Other trials in Belgium

Germany5 sites

Study site
Dresden
Study site
Freiburg im Breisgau
Study site
Hamburg
Study site
Leipzig
Study site
Munich

Other trials in Germany

Latvia1 site

Study site
Riga

Other trials in Latvia

About this study

Conditions: Cardiac Surgical Procedures, Hemorrhage
Being tested: Veriset Hemostatic Patch, TachoSil®
Medical subject headings: Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Veriset Hemostatic PatchDevice
Topical hemostat
TachoSil®Device
Topical Hemostat

Study groups in NCT01639833
Study group	Role	What they receive
Veriset Hemostatic Patch	Experimental	Topical Hemostat Receives: Device: Veriset Hemostatic Patch
TachoSil®	Active comparator	Topical Hemostat Receives: Device: TachoSil®

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Hemostasis (TTH)
Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).
Measured: Day 0

Secondary outcomes (1)

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.
Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Dec 2013

First posted13 Jul 2012 (estimated)
Study startAug 2012
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01639833
Sponsor's protocol ID: COVEUCV0140
Status last verified: Jun 2014
First submitted: 11 Jul 2012
Last updated: 3 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Active, not recruiting
Comparing Different Regional Blocks for Analgesia After Off-pump Cardiac Surgery
Analgesia
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
Active, not recruiting
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)

All Cardiac Surgical Procedures trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01639833
Acronym / sponsor ID: COVEUCV0140
Conditions: Cardiac Surgical Procedures, Hemorrhage
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 13 Jul 2012 (estimated)
Results: Posted 3 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Veriset Hemostatic Patch	Experimental	Device: Veriset Hemostatic PatchTopical Hemostat
TachoSil®	Active comparator	Device: TachoSil®Topical Hemostat

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Veriset Hemostatic PatchTopical hemostat	Device	Veriset Hemostatic Patch
TachoSil®Topical Hemostat	Device	TachoSil®

Primary outcome

Time to Hemostasis (TTH)
Time frame: Day 0
Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).

1 secondary outcome

Hemostasis at All Treated Bleeding Sites Within 3 Minutes
Time frame: Day 0

Results and safety

Results posted to the registry on 3 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Veriset™ Hemostatic Patch	45	39
TachoSil®	45	41

Primary outcome: Time to Hemostasis (TTH)

Time frame: Day 0. Median (95% Confidence Interval). Unit: minutes

Measure	Veriset™ Hemostatic Patch n = 41	TachoSil® n = 45
Value	1.50 (1.50 to 2.00)	3.00 (NA to NA)

Population analysed: The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected through the 90 day follow-up visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Veriset™ Hemostatic Patch	13 of 44 (29.5%)	23 of 44 (52.3%)	Not reported
TachoSil®	11 of 45 (24.4%)	21 of 45 (46.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cardiac Surgical Procedures

RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Active, not recruiting
Comparing Different Regional Blocks for Analgesia After Off-pump Cardiac Surgery
Analgesia
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
Active, not recruiting
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Glineur, MD principal investigator

Clinique St-Luc Bouge, Namur, Belgium

12 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Veriset Hemostatic Patch and TachoSil® in people with Cardiac Surgical Procedures and Hemorrhage, run by Medtronic - MITG at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Belgium, Germany, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Hemostasis (TTH) (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01639833.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2014.