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

Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324349
• Other study ID #: COVEULV0032
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: January 29, 2014
• Start date: February 2011
• Est. completion date: September 2011

Study information

• Verified date: January 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesAustria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Device:
• Veriset Hemostatic Patch
Topical hemostat
• Fibrin Sealant (TachoSil®)
Topical hemostat

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

Austria,  Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	Number of Subjects With Treatment-emergent Adverse Events		Up to 30 days post surgery.	Yes