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

NCT00918619 | Completed Phase 4

• 1 other identifier: AAG-G-H-0804
• Study Type: interventional
• Target: 128
• Locations: 2 countries
• Sites: 8

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.

Conditions

Hemostasis; Liver Surgery

Keywords

randomized,; controlled,; haemostatic agents,; Sangustop,; Tachosil,; liver resection,; haemostasis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with hemostasis 3 minutes after application of the haemostat product

  3 minutes

Secondary Outcomes (1)

• Time to hemostasis

  10 minutes

Study Arms (2)

Sangustop

EXPERIMENTAL

Device: Sangustop

Tachosil

ACTIVE COMPARATOR

Drug: Tachosil

Interventions

Sangustop DEVICE

Application of Sangustop haemostatic agent on resection area

Also known as: Sangustop®

Sangustop

Tachosil DRUG

Application of Tachosil fibrin sealant on resection area

Also known as: Tachosil®

Tachosil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Resection area estimated by operating surgeon \< 16cm2
• Infected wound area
• Persistant major bleeding after primary haemostasis
• No bleeding after resection

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (8)

Universitätsklinik für Chirurgie, Medizinische Universität Graz

Graz, 8036, Austria

Location

Charité Campus Virchow, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Berlin, 13353, Germany

Location

Krankenhaus Nordwest, Klinik für Allgemein-, Viszeral- und Minimal Invasive Chirurgie

Frankfurt, 60488, Germany

Location

Klinikum der J. W. Goethe-Universität, Klinik für Allgemein- und Visceralchirurgie

Frankfurt am Main, 60590, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Mainz, Klinik für Allgemein- und Abdominalchirurgie

Mainz, 55131, Germany

Location

Klinikum Großhadern, Ludwig-Maximilians-Universität

München, 81377, Germany

Location

Technische Universität München, Chirurgische Klinik und Poliklinik

München, 81675, Germany

Location

Related Publications (3)

• Moench C, Bechstein WO, Hermanutz V, Hoexter G, Knaebel HP. Comparison of the collagen haemostat Sangustop(R) versus a carrier-bound fibrin sealant during liver resection; ESSCALIVER-Study. Trials. 2010 Nov 19;11:109. doi: 10.1186/1745-6215-11-109.

  PMID: 21087530 BACKGROUND

• Moench C, Mihaljevic AL, Hermanutz V, Thasler WE, Suna K, Diener MK, Seehofer D, Mischinger HJ, Jansen-Winkeln B, Knaebel HP, Bechstein WO. Randomized controlled multicenter trial on the effectiveness of the collagen hemostat Sangustop(R) compared with a carrier-bound fibrin sealant during liver resection (ESSCALIVER study, NCT00918619). Langenbecks Arch Surg. 2014 Aug;399(6):725-33. doi: 10.1007/s00423-014-1203-9. Epub 2014 Jun 1.

  PMID: 24880345 RESULT

• Malik AK, Amer AO, Tingle SJ, Thompson ER, White SA, Manas DM, Wilson C. Fibrin-based haemostatic agents for reducing blood loss in adult liver resection. Cochrane Database Syst Rev. 2023 Aug 8;8(8):CD010872. doi: 10.1002/14651858.CD010872.pub2.

  PMID: 37551841 DERIVED

MeSH Terms

Interventions

TachoSil

Study Officials

• Wolf O. Bechstein, Prof. Dr.

  University Hospital, Frankfurt am Main, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: January 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2011
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

AU (1); DE (7)