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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemostasis, Liver Surgery

Intervention / Treatment
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* Device: Sangustop
* Drug: Tachosil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sangustop<br> | Device: Sangustop<br>* Application of Sangustop haemostatic agent on resection area<br>* Other names: Sangustop®;|
| Active Comparator: Tachosil<br> | Drug: Tachosil<br>* Application of Tachosil fibrin sealant on resection area<br>* Other names: Tachosil®;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis |  | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized,, controlled,, haemostatic agents,, Sangustop,, Tachosil,, liver resection,, haemostasis