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

Hemostasis Clinical Trial

— ESSCALIVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918619
• Other study ID #: AAG-G-H-0804
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2009
• Last updated: May 27, 2015
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: May 2015
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemostasis
• Liver Surgery

Intervention

Device:
• Sangustop
Application of Sangustop haemostatic agent on resection area

Drug:
• Tachosil
Application of Tachosil fibrin sealant on resection area

Locations

Country	Name	City	State
Austria	Universitätsklinik für Chirurgie, Medizinische Universität Graz	Graz
Germany	Charité Campus Virchow, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie	Berlin
Germany	Krankenhaus Nordwest, Klinik für Allgemein-, Viszeral- und Minimal Invasive Chirurgie	Frankfurt
Germany	Klinikum der J. W. Goethe-Universität, Klinik für Allgemein- und Visceralchirurgie	Frankfurt am Main
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum Mainz, Klinik für Allgemein- und Abdominalchirurgie	Mainz
Germany	Klinikum Großhadern, Ludwig-Maximilians-Universität	München
Germany	Technische Universität München, Chirurgische Klinik und Poliklinik	München

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (2)

Moench C, Bechstein WO, Hermanutz V, Hoexter G, Knaebel HP. Comparison of the collagen haemostat Sangustop® versus a carrier-bound fibrin sealant during liver resection; ESSCALIVER-Study. Trials. 2010 Nov 19;11:109. doi: 10.1186/1745-6215-11-109. — View Citation

Moench C, Mihaljevic AL, Hermanutz V, Thasler WE, Suna K, Diener MK, Seehofer D, Mischinger HJ, Jansen-Winkeln B, Knaebel HP, Bechstein WO. Randomized controlled multicenter trial on the effectiveness of the collagen hemostat Sangustop® compared with a ca — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with hemostasis 3 minutes after application of the haemostat product		3 minutes	No
Secondary	Time to hemostasis		10 minutes	No