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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemostasis; Liver Surgery
• Intervention / Treatment: Device: Sangustop; Drug: Tachosil

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Universitätsklinik für Chirurgie, Medizinische Universität Graz
• Germany
  • Berlin, Germany, 13353
    • Charité Campus Virchow, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
  • Frankfurt, Germany, 60488
    • Krankenhaus Nordwest, Klinik für Allgemein-, Viszeral- und Minimal Invasive Chirurgie
  • Frankfurt am Main, Germany, 60590
    • Klinikum der J. W. Goethe-Universität, Klinik für Allgemein- und Visceralchirurgie
  • Heidelberg, Germany, 69120
    • UniversitatsKlinikum Heidelberg
  • Mainz, Germany, 55131
    • Universitätsklinikum Mainz, Klinik für Allgemein- und Abdominalchirurgie
  • München, Germany, 81377
    • Klinikum Großhadern, Ludwig-Maximilians-Universität
  • München, Germany, 81675
    • Technische Universität München, Chirurgische Klinik und Poliklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sangustop	Device: Sangustop; Application of Sangustop haemostatic agent on resection area; Other Names: Sangustop®
ACTIVE_COMPARATOR: Tachosil	Drug: Tachosil; Application of Tachosil fibrin sealant on resection area; Other Names: Tachosil®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with hemostasis 3 minutes after application of the haemostat product	3 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to hemostasis	10 minutes

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Wolf O. Bechstein, Prof. Dr., University Hospital, Frankfurt am Main, Germany

Publications and helpful links

General Publications

• Moench C, Bechstein WO, Hermanutz V, Hoexter G, Knaebel HP. Comparison of the collagen haemostat Sangustop(R) versus a carrier-bound fibrin sealant during liver resection; ESSCALIVER-Study. Trials. 2010 Nov 19;11:109. doi: 10.1186/1745-6215-11-109.
• 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(R) compared with a carrier-bound fibrin sealant during liver resection (ESSCALIVER study, NCT00918619). Langenbecks Arch Surg. 2014 Aug;399(6):725-33. doi: 10.1007/s00423-014-1203-9. Epub 2014 Jun 1.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: June 9, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (ESTIMATE): June 11, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: haemostasis; randomized,; controlled,; haemostatic agents,; Sangustop,; Tachosil,; liver resection,
• Other Study ID Numbers: AAG-G-H-0804