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

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

NCT01324349•Medtronic - MITG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Scheduled for non-emergent, hepatic surgery
•Presence of an appropriate target bleeding site (TBS) as defined by the protocol

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

Locations (6)

Innsbruck, Austria

Ghent, Belgium

Leuven, Belgium

Hanover, Germany

Heidelberg, Germany

München, Germany

Key Dates

Start Date

February 1, 2011

Primary Completion Date

September 1, 2011

Completion Date

September 1, 2011

Last Updated

March 3, 2014

Enrollment

ACTUAL participants

Conditions

Liver Disease

Interventions

Veriset Hemostatic Patch

DEVICE

Fibrin Sealant (TachoSil®)

DEVICE

Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry

NCT07480057

Chronic Liver Disease and ACLF

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RECRUITINGNA

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss

NCT07237750

Overweight and/or ObesityMetabolic Syndrome+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss

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