Liver DiseaseNCT01324349
Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
A study testing Veriset Hemostatic Patch and Fibrin Sealant (TachoSil®) in people with Liver Disease, run by Medtronic - MITG at 6 sites in 3 countries.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease
- What is being tested?
- Veriset Hemostatic Patch and Fibrin Sealant (TachoSil®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Feb 2011to Sep 2011
- 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
Major Inclusion Criteria:
- Scheduled for non-emergent, hepatic surgery
- Presence of an appropriate target bleeding site (TBS) as defined by the protocol
Major Exclusion Criteria:
- Subject will be undergoing a laparoscopic hepatic procedure where the Hemostatic Patch will be delivered and applied through a trocar
- In subjects with documented history of cirrhosis, subject has uncorrected platelet count <60,000 per mm³ as determined by laboratory tests performed immediately prior to surgery
- Subject has severe coagulopathy defined as INR > 2.0
- Subject has Total Bilirubin >2.5mg/dL
- Subject has an active local infection at the Target Bleeding Site
- Study procedure involves a liver transplant recipient
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
About this study
Official title: A Prospective, Multi-Center, Randomized, Single-Blind Study to Compare the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques.
- Conditions
- Liver Disease
- Being tested
- Veriset Hemostatic Patch, Fibrin Sealant (TachoSil®)
- Keywords
- Hepatic, Topical Hemostat
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veriset Hemostatic PatchDevice
Topical hemostat
Fibrin Sealant (TachoSil®)Device
Topical hemostat
| Study group | Role | What they receive |
|---|---|---|
| Veriset Hemostatic Patch | Experimental | Veriset Hemostatic Patch Receives: Device: Veriset Hemostatic Patch |
| Fibrin Sealant (TachoSil®) | Active comparator | Fibrin Sealant (TachoSil®) Receives: Device: Fibrin Sealant (TachoSil®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time to Achieve Hemostasis Following Application of Study Treatment.
Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Measured: Intra-operative (day 1)
Secondary outcomes (2)
Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application
Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Measured: Intra-operative (day 1)
Number of Subjects With Treatment-emergent Adverse Events
Measured: Up to 30 days post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2011
- Study completionSep 2011
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 Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Pollack, MD, Study director, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324349
- Sponsor's protocol ID
- COVEULV0032
- Status last verified
- Jan 2014
- First submitted
- 24 Mar 2011
- Last updated
- 3 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized, Single-Blind Study to Compare the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
- ClinicalTrials.gov ID
- NCT01324349
- Acronym / sponsor ID
- COVEULV0032
- Conditions
- Liver Disease
- Keywords
- Hepatic, Topical Hemostat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Posted 12 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veriset Hemostatic Patch | Experimental | Device: Veriset Hemostatic PatchVeriset Hemostatic Patch |
| Fibrin Sealant (TachoSil®) | Active comparator | Device: Fibrin Sealant (TachoSil®)Fibrin Sealant (TachoSil®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
| Fibrin Sealant (TachoSil®)Topical hemostat | Device | Fibrin Sealant (TachoSil®) |
Primary outcome
Median Time to Achieve Hemostasis Following Application of Study Treatment.
Time frame: Intra-operative (day 1)
Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
2 secondary outcomes
Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application
Time frame: Intra-operative (day 1)
Number of Subjects With Treatment-emergent Adverse Events
Time frame: Up to 30 days post surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Amy Pollack, MD study director
Medtronic - MITG
6 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 Fibrin Sealant (TachoSil®) in people with Liver Disease, run by Medtronic - MITG at 6 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?
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 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Belgium, Austria. 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 12 Sep 2012). 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?
Median Time to Achieve Hemostasis Following Application of Study Treatment. (time frame: Intra-operative (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2014.