Male and female patients with indication for elective liver resection. The indication is to achieve haemostasis after liver resection. MedDRA version: 11.0 Level: LLT Classification code 10062040 Term:
Conditions
Interventions
Trade Name: TachoSil
Pharmaceutical Form: Medicated sponge
CAS Number: 9001-32-5
Other descriptive name: HUMAN FIBRINOGEN
Concentration unit: cm2 square centimeter
Concentration type: equal
Concentrat
Sponsors
Aesculap AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this clinical trial is to compare the efficacy and safety of Sangustop® as haemostatic agent versus a carrier-bound fibrin sealant during liver resection.;Secondary Objective: ;Primary end point(s): Proportion of patients with hemostasis 3 minutes after application of the haemostat product. | — |
Countries
Austria, Germany
Outcome results
None listed