Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-Bound Fibrin Sealant During Liver Resection

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres. The primary objective of this study is to show that the collagen based haemostatic device Sangustop® is not inferior to a carrier-bound fibrin sealant (Tachosil®) in achieving haemostasis after hepatic resection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aesculap AG
• Treatments: Fibrin Tissue Adhesive; Hemostatics

Criteria

Inclusion:

• Age: > 18 years

• Gender: male / female

• Patients with an indication for liver resection (segmental or non-segmental)

• Willing and able to complete the clinical trial procedures, as described in the protocol

• Signed written informed consent to participate in this clinical trial

Exclusion:

• Presence or sequelae of coagulation disorder, liver cirrhosis, Klatskin tumor

• Concurrent participation in another clinical trial with a medical device or medicinal product or with interfering endpoints

• Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting including but not limited to tranexamix acid, activated factor VII, and aprotinine

• Known allergy or hypersensitivity to a component of the investigational treatments Sangustop® or TachoSil®, to riboflavin or to proteins of bovine origin

• Pregnancy or breast feeding

• Inability to understand the nature and the extent of the trial and the procedures required

• Missing signed written informed consent to participate in the study

Exclusion criteria to be checked during surgery (liver resection):

• Resection area estimated by operating surgeon < 16cm2

• Infected wound area

• Persistant major bleeding after primary haemostasis

• No bleeding after resection