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

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.

Study Locations

      • Innsbruck, Austria
      • Gent, Belgium
      • Leuven, Belgium
      • Hannover, Germany
      • Heidelberg, Germany
      • München, Germany

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.

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

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.

Clinical Trials on Liver Disease

Clinical Trials on Veriset Hemostatic Patch

3
Subscribe