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

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.

Timeline

Start

2010-01

Primary completion

2010-10

Completion

2011-01

Publications

• Background 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.
• Results 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.
• 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.

Drugs

Indications