NCT00918619

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

Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-bound Fibrin Sealant During Liver Resection (ESSCALIVER)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

During liver resection the control of bleeding is a major concern. The liver is predisposed to diffuse bleeding because of its extreme vascularity. Locally applicable agents (haemostats) are in use in order to achieve control over parenchymatic diffuse bleeding from the resection surface and to prevent intraperitoneal complications attributed to bleeding. These haemostats include bone wax, gelatine, collagen, oxidized regenerated cellulose, fibrin sealant glues, and synthetic glues. A composite product with well documented efficacy is Tachosil®. It consists of a collagen fleece carrying the fibrin glue components human fibrinogen and human thrombin. It was shown in a RCT to be superior in obtaining intraoperative haemostasis over argon beamer in liver resection. A new haemostat product is Sangustop®. It is indicated for local haemostasis of capillary bleeding and bleeding of parenchymal organs. Sangustop® is composed of native absorbable collagen fibrils without any blood serum products or any pharmaceutical activity. The felt structure being rich in surface gives a framework for the adhesion of blood platelets, thus provides an additional impetus to clotting. The aim of this study is to show that the new microfibrillar collagen hemostat Sangustop® is not inferior to the carrier-bound fibrin sealant Tachosil® with regards to haemostatic efficacy.

Conditions

• Hemostasis
• Liver Surgery

Interventions

Type	Name	Description
DEVICE	Sangustop	Application of Sangustop haemostatic agent on resection area
DRUG	Tachosil	Application of Tachosil fibrin sealant on resection area

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-10-01
• Completion: 2011-01-01
• First posted: 2009-06-11
• Last updated: 2015-05-28

Locations

8 sites across 2 countries: Austria, Germany