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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00918619
• Date of registration: 09/06/2009
• Primary sponsor: Aesculap AG
• Public title: Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-Bound Fibrin Sealant During Liver Resection ESSCALIVER
• Scientific title: Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-bound Fibrin Sealant During Liver Resection (ESSCALIVER)
• Date of first enrolment: January 2010
• Target sample size: 126
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00918619
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Countries of recruitment

Austria, Germany

Contacts

• Name: Wolf O. Bechstein, Prof. Dr.
• Affiliation: University Hospital, Frankfurt am Main, Germany

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hemostasis

Liver Surgery

Intervention(s)

Device: Sangustop

Drug: Tachosil

Primary Outcome(s)

Proportion of patients with hemostasis 3 minutes after application of the haemostat product [Time Frame: 3 minutes]

Secondary Outcome(s)

Time to hemostasis [Time Frame: 10 minutes]

Secondary ID(s)

AAG-G-H-0804

Source(s) of Monetary Support

Please refer to primary and secondary sponsors