E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epatic resection (minor or major) |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | 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). |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |