Efficacy and Safety of Sangustop® as haemostatic agent versus a carrier-bound fibrin sealant during liver resection (ESSCALIVER) - ESSCALIVER

Conditions: Male and female patients with indication for elective liver resection. The indication is to achieve haemostasis after liver resection.
MedDRA version: 11.0Level: LLTClassification code 10062040Term: <Manually entered code. Term in E.1.1>

Registration Number: EUCTR2008-001583-36-AT

Lead Sponsor: Aesculap AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 126

Inclusion Criteria

- Age: > 18 years
- Gender: male / female
- Patients with an indication for liver elective resection (segmental or non-segmental)
- Female patients must either be at least two years postmenopausal or have a negative serum or urine pregnancy test prior to study entry and be using one of the following means of birth control: surgical sterility, double barrier methods, hormonal contraception, intraunterine contraceptive device, lifestyle with a personal choice of abstinence, vasectomy of sexual partner at least 3 months prior to enrolment in combination with barrier methods
- Willing and able to complete the clinical trial procedures, as described in the protocol
- Signed written informed consent to participate in this clinical trial

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Presence or sequelae of coagulation disorder, liver cirrhosis, Klatskin tumor
- Participation in another clinical trial with a medical device or medicinal product or
with interfering endpoints - currently or during the past month
- 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
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