- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01324349
Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
January 29, 2014 updated by: Medtronic - MITG
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Veriset Hemostatic Patch
|
Topical hemostat
|
Active Comparator: Fibrin Sealant (TachoSil®)
|
Topical hemostat
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Intra-operative (day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application
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.
|
Intra-operative (day 1)
|
Number of Subjects With Treatment-emergent Adverse Events
Time Frame: Up to 30 days post surgery.
|
Up to 30 days post surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amy Pollack, MD, Medtronic - MITG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
March 24, 2011
First Submitted That Met QC Criteria
March 28, 2011
First Posted (Estimate)
March 29, 2011
Study Record Updates
Last Update Posted (Estimate)
March 3, 2014
Last Update Submitted That Met QC Criteria
January 29, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVEULV0032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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