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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Disease

Intervention / Treatment
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* Device: Veriset Hemostatic Patch
* Device: Fibrin Sealant (TachoSil®)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Veriset Hemostatic Patch<br>Veriset Hemostatic Patch | Device: Veriset Hemostatic Patch<br>* Topical hemostat<br>|
| Active Comparator: Fibrin Sealant (TachoSil®)<br>Fibrin Sealant (TachoSil®) | Device: Fibrin Sealant (TachoSil®)<br>* Topical hemostat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 |  | Up to 30 days post surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic, Topical Hemostat