Evaluation of Haemostatic Efficacy, Tolerability and Safety of Kedrion Fibrin Sealant in patients undergoing major or minor Liver Surgery. Multicenter, Controlled, Open Label Randomised Phase II/III study. - KB048

KEDRIO0 个研究点开始时间: 2009年6月30日最近更新: 2012年3月19日

试验速览

暂无简介。

•1.Age > 18 years
•2.Anatomical and non-anatomical resections, whose section is > 20 cm2
•3.The subjects or their authorized legal representatives must have received adequate information regarding the nature of the trial, agree on study purposes, and have signed an informed consent form approved by the Ethical Committee.
•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

•1.Anatomical and non-anatomical resections, whose section is < 20 cm2
•2.Use of haemostatic agents apart from those foreseen by the study protocol
•3.History of congenital coagulation disorders
•4. Presence of any conditions which, in the investigator?s judgment, may interfere with study objective evaluation or with the patient?s participation in the study.
•5.Previous exposure to products containing aprotinine of bovine origin
•6.The patient refused to sign the written informed consent required for participation, or participated in another clinical study during the month prior to study start date (the subject received other study drugs during the last 30 days).
•7.Known allergies to hemoderivatives and/or to haemocomponents.

发起方

KEDRIO