Epatic resection (minor or major)
Conditions
Interventions
Product Name: Fibrin sealant Kedrion
Pharmaceutical Form: Sealant
INN or Proposed INN: Combinations
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Sponsors
KEDRION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Efficacy evaluation of KFS in the control of intraoperative haematic losses during major or minor haepatic surgery 2. Safety evaluation of KFS throughout the study.;Secondary Objective: 1. Efficacy evaluation of KFS in the control of haematic losses following major or minor haepatic surgery. 2. Efficacy evaluation of KFS in the control of bile leakage 3. Economical evaluation of the IMP treatment.;Primary end point(s): Efficacy 1. Percentage of patients that achieved hemostasis whitin 10 minutes from treatment application. Safety and tolerability: 1. Absence of antibodies against bovine aprotinine. 2. Percentage of subjects in whom treatment-related adverse events occur (classified as possibly or likely related). | — |
Countries
Italy
Outcome results
None listed