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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00918619
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
Aesculap AG

Brief 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.

Condition or disease Intervention/treatment Phase
Hemostasis Liver Surgery Device: Sangustop Drug: Tachosil Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-bound Fibrin Sealant During Liver Resection (ESSCALIVER)
Study Start Date : January 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: TachoSil

Arm Intervention/treatment
Experimental: Sangustop Device: Sangustop
Application of Sangustop haemostatic agent on resection area
Other Name: Sangustop®

Active Comparator: Tachosil Drug: Tachosil
Application of Tachosil fibrin sealant on resection area
Other Name: Tachosil®

Primary Outcome Measures :
  1. Proportion of patients with hemostasis 3 minutes after application of the haemostat product [ Time Frame: 3 minutes ]

Secondary Outcome Measures :
  1. Time to hemostasis [ Time Frame: 10 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00918619

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Universitätsklinik für Chirurgie, Medizinische Universität Graz
Graz, Austria, 8036
Charité Campus Virchow, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Berlin, Germany, 13353
Klinikum der J. W. Goethe-Universität, Klinik für Allgemein- und Visceralchirurgie
Frankfurt am Main, Germany, 60590
Krankenhaus Nordwest, Klinik für Allgemein-, Viszeral- und Minimal Invasive Chirurgie
Frankfurt, Germany, 60488
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitätsklinikum Mainz, Klinik für Allgemein- und Abdominalchirurgie
Mainz, Germany, 55131
Klinikum Großhadern, Ludwig-Maximilians-Universität
München, Germany, 81377
Technische Universität München, Chirurgische Klinik und Poliklinik
München, Germany, 81675
Sponsors and Collaborators
Aesculap AG
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Principal Investigator: Wolf O. Bechstein, Prof. Dr. University Hospital, Frankfurt am Main, Germany
Publications of Results:
Other Publications:
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Responsible Party: Aesculap AG Identifier: NCT00918619    
Other Study ID Numbers: AAG-G-H-0804
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Aesculap AG:
haemostatic agents,
liver resection,