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

Not Applicable

Completed

• Conditions: Liver Disease
• Interventions: Device: Veriset Hemostatic Patch; Device: Fibrin Sealant (TachoSil®)

• Registration Number: NCT01324349
• Lead Sponsor: Medtronic - MITG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2012-06-20
• Results First Submitted QC: 2012-08-13
• Results First Posted: 2012-09-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-29
• Last Update Posted: 2014-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Veriset Hemostatic Patch	Veriset Hemostatic Patch	Veriset Hemostatic Patch
Fibrin Sealant (TachoSil®)	Fibrin Sealant (TachoSil®)	Fibrin Sealant (TachoSil®)

Primary Outcome Measures

Name	Time	Method
Median Time to Achieve Hemostasis Following Application of Study Treatment.	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application	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.
Number of Subjects With Treatment-emergent Adverse Events	Up to 30 days post surgery.