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

Aesculap AG0 个研究点目标入组 126 人开始时间: 2010年4月12日最近更新: 2012年3月19日

试验速览

暂无简介。

•- 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

•- 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

发起方