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

Medtronic

Status: Completed

Conditions: Liver Disease

Treatments: Device: Veriset Hemostatic Patch; Device: Fibrin Sealant (TachoSil®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01324349

COVEULV0032

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Veriset Hemostatic Patch

Experimental group

Description:

Veriset Hemostatic Patch

Treatment:

Device: Veriset Hemostatic Patch

Fibrin Sealant (TachoSil®)

Active Comparator group

Description:

Fibrin Sealant (TachoSil®)

Treatment:

Device: Fibrin Sealant (TachoSil®)