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Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery

Primary Purpose

Liver Disease

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Veriset Hemostatic Patch

Fibrin Sealant (TachoSil®)

About this trial

This is an interventional treatment trial for Liver Disease focused on measuring Hepatic, Topical Hemostat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Veriset Hemostatic Patch

Fibrin Sealant (TachoSil®)

Arm Description

Veriset Hemostatic Patch

Fibrin Sealant (TachoSil®)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application

Number of Subjects With Treatment-emergent Adverse Events

Full Information

NCT ID

NCT01324349

First Posted

March 24, 2011

Last Updated

January 29, 2014

Sponsor

Medtronic - MITG

1. Study Identification

Unique Protocol Identification Number

NCT01324349

Brief Title

Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery

Official Title

A Prospective, Multi-Center, Randomized, Single-Blind Study to Compare the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic - MITG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Disease

Keywords

Hepatic, Topical Hemostat

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Veriset Hemostatic Patch

Arm Type

Experimental

Arm Description

Veriset Hemostatic Patch

Arm Title

Fibrin Sealant (TachoSil®)

Arm Type

Active Comparator

Arm Description

Fibrin Sealant (TachoSil®)

Intervention Type

Device

Intervention Name(s)

Veriset Hemostatic Patch

Intervention Description

Topical hemostat

Intervention Type

Device

Intervention Name(s)

Fibrin Sealant (TachoSil®)

Intervention Description

Topical hemostat

Primary Outcome Measure Information:

Title

Median Time to Achieve Hemostasis Following Application of Study Treatment.

Description

Time Frame

Intra-operative (day 1)

Secondary Outcome Measure Information:

Title

Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application

Description

Time Frame

Intra-operative (day 1)

Title

Number of Subjects With Treatment-emergent Adverse Events

Time Frame

Up to 30 days post surgery.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy Pollack, MD

Organizational Affiliation

Medtronic - MITG

Official's Role

Study Director

Facility Information:

City

Innsbruck

Country

Austria

City

Gent

Country

Belgium

City

Leuven

Country

Belgium

City

Hannover

Country

Germany

City

Heidelberg

Country

Germany

City

München

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery

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