E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who are undergoing liver resection. The surgery can be performed for any reason: usually primary or secondary carcinoma but may be performed for other non malignant abnormality or liver disease. |
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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 |
To evaluate the efficacy of the use of Tisseel versus the absence of the use of Tisseel (or other haemostatic agent) during liver resection surgery in the prevention of post operative resection bed fluid collections |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female patients of any race, between 18 and 90 years of age. • Patients due to undergo liver resection. • Female patients of child bearing potential must have a negative urine pregnancy test prior to random assignment. • Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) and has given oral informed consent witnessed by an independent person.
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E.4 | Principal exclusion criteria |
• Patient has known hypersensitivity to aprotinin • Patient has had a previous liver resection where Tisseel was used (risk of hypersensitivity) • Patient has known abnormal liver parenchyma (significant fibrosis or cirrhosis) • Patient has pre-operative coagulation disorders (PT > 20 seconds) • Patient has pre-operative ascites • Patient has platelet count of <75 000 • Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 3 months • Patient is pregnant or breast feeding • Abnormal liver parenchyma determined intra-operatively (significant fibrosis or cirrhosis) • Failure to achieve haemostasis without the need of sealants • Concomitant bile duct reconstruction • Lymphadenectomy in excess of regional
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is the incidence of resection bed fluid collections. |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Yes |
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
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Last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |