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

This study has been completed.
Sponsor:
Information provided by:
Aesculap AG
ClinicalTrials.gov Identifier:
NCT00918619
First received: June 9, 2009
Last updated: April 26, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention Phase
Hemostasis
Liver Surgery
 Device: Sangustop
Drug: Tachosil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-bound Fibrin Sealant During Liver Resection (ESSCALIVER)

Resource links provided by NLM:

Drug Information available for: TachoSil
U.S. FDA Resources

Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • Proportion of patients with hemostasis 3 minutes after application of the haemostat product [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to hemostasis [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918619

Locations
Austria
Universitätsklinik für Chirurgie, Medizinische Universität Graz
Graz, Austria, 8036
Germany
Charité Campus Virchow, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Berlin, Germany, 13353
Krankenhaus Nordwest, Klinik für Allgemein-, Viszeral- und Minimal Invasive Chirurgie
Frankfurt, Germany, 60488
Klinikum der J. W. Goethe-Universität, Klinik für Allgemein- und Visceralchirurgie
Frankfurt am Main, Germany, 60590
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitätsklinikum Mainz, Klinik für Allgemein- und Abdominalchirurgie
Mainz, Germany, 55131
Technische Universität München, Chirurgische Klinik und Poliklinik
München, Germany, 81675
Klinikum Großhadern, Ludwig-Maximilians-Universität
München, Germany, 81377
Sponsors and Collaborators
Aesculap AG
Investigators
Principal Investigator: Wolf O. Bechstein, Prof. Dr. University Hospital, Frankfurt am Main, Germany
  More Information

No publications provided by Aesculap AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Valentin Hermanutz, Aesculap AG
ClinicalTrials.gov Identifier: NCT00918619     History of Changes
Other Study ID Numbers: AAG-G-H-0804
Study First Received: June 9, 2009
Last Updated: April 26, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Aesculap AG:
randomized,
controlled,
haemostatic agents,
Sangustop,
 Tachosil,
liver resection,
haemostasis

Additional relevant MeSH terms:
Fibrin Tissue Adhesive
Hemostatics
Coagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013