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

June 9, 2009
April 26, 2011
January 2010
October 2010   (final data collection date for primary outcome measure)
Proportion of patients with hemostasis 3 minutes after application of the haemostat product [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00918619 on ClinicalTrials.gov Archive Site
Time to hemostasis [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Hemostasis
  • Liver Surgery
  • Device: Sangustop
    Application of Sangustop haemostatic agent on resection area
    Other Name: Sangustop®
  • Drug: Tachosil
    Application of Tachosil fibrin sealant on resection area
    Other Name: Tachosil®
  • Experimental: Sangustop
    Intervention: Device: Sangustop
  • Active Comparator: Tachosil
    Intervention: Drug: Tachosil
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
January 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00918619
AAG-G-H-0804
No
Dr. Valentin Hermanutz, Aesculap AG
Aesculap AG
Not Provided
Principal Investigator: Wolf O. Bechstein, Prof. Dr. University Hospital, Frankfurt am Main, Germany
Aesculap AG
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP