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

Phase 4

Completed

• Conditions: Hemostasis; Liver Surgery
• Interventions: Device: Sangustop; Drug: Tachosil

• Registration Number: NCT00918619
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-11
• Study Start: 2010-01
• Primary Completion: 2010-10
• Study Completion: 2011-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sangustop	Sangustop	-
Tachosil	Tachosil	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with hemostasis 3 minutes after application of the haemostat product	3 minutes

Secondary Outcome Measures

Name	Time	Method
Time to hemostasis	10 minutes

Trial Locations

Locations (8)

Universitätsklinik für Chirurgie, Medizinische Universität Graz; 🇦🇹 Graz, Austria

Charité Campus Virchow, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie; 🇩🇪 Berlin, Germany

Klinikum Großhadern, Ludwig-Maximilians-Universität; 🇩🇪 München, Germany

Universitätsklinikum Mainz, Klinik für Allgemein- und Abdominalchirurgie; 🇩🇪 Mainz, 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

Technische Universität München, Chirurgische Klinik und Poliklinik; 🇩🇪 München, Germany