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
- Conditions
- Epatic resection (minor or major)
- Registration Number
- EUCTR2009-011603-23-IT
- Lead Sponsor
- KEDRIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method