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

NCT01324349 | Completed Results DMC

• 1 other identifier: COVEULV0032
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 6

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.

Conditions

Liver Disease

Keywords

Hepatic; Topical Hemostat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Intra-operative (day 1)

• Number of Subjects With Treatment-emergent Adverse Events

  Up to 30 days post surgery.

Study Arms (2)

Veriset Hemostatic Patch

EXPERIMENTAL

Veriset Hemostatic Patch

Device: Veriset Hemostatic Patch

Fibrin Sealant (TachoSil®)

ACTIVE COMPARATOR

Fibrin Sealant (TachoSil®)

Device: Fibrin Sealant (TachoSil®)

Interventions

Veriset Hemostatic Patch DEVICE

Topical hemostat

Veriset Hemostatic Patch

Fibrin Sealant (TachoSil®) DEVICE

Topical hemostat

Fibrin Sealant (TachoSil®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (6)

Unknown Facility

Innsbruck, Austria

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Heidelberg, Germany

Location

Unknown Facility

München, Germany

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Covidien

amy.pollack@covidien.com

203-500-4256

Study Officials

• Amy Pollack, MD

  Medtronic - MITG

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 29, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 3, 2014
• Results First Posted: September 12, 2012

Record last verified: 2014-01

Locations

AU (1); BE (2); DE (3)