E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hemostasis in hepatic resection |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060663 |
E.1.2 | Term | Surgical hemostasis |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067440 |
E.1.2 | Term | Hemostasis |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 FS VH S/D 500 s-apr for hemostasis in subjects undergoing partial hepatic resection, as compared to a control arm treated by manual compression with a surgical gauze swab. |
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E.2.2 | Secondary objectives of the trial |
To assess safety, i.e. adverse events. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Preoperative inclusion criteria:
• Signed informed consent obtained from the subject before any study-related activities • Subject’s age is 18 years or above • Subject will undergo planned, elective resection of at least 1 anatomical segment of the liver for any reason by laparotomy • Subject is willing and able to comply with the requirements of the protocol • Female subjects of childbearing potential must present with a negative serum or urine pregnancy test within 72 hours before the elective liver resection • Female subjects of childbearing potential must agree to employ adequate birth control measures for the duration of their participation in the study
Intraoperative inclusion criteria (before randomization):
• Resection of at least 1 anatomical segment of the liver has been performed • Oozing from the cut surface of the liver persists after conventional resection procedure and primary control of arterial and venous bleeding by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation • Need for additional supportive hemostatic treatment to stop bleeding (i.e. diffuse oozing) of the liver resection area |
|
E.4 | Principal exclusion criteria |
Preoperative exclusion criteria:
• Subject needs emergency liver surgery • Subject will undergo liver resection via laparoscopic procedure • Subject has known congenital coagulation disorder (e.g. hemophilia) • Subject has known hypersensitivity to any ingredient of the investigational medicinal product • Suspected inability or unwillingness of the subject to comply with trial procedures • If female, subject is pregnant or lactating at the time of study enrollment • Subject has already participated in this study (each subject can only be enrolled once) • Subject has participated in another clinical study involving an IP or investigational device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
Intraoperative Exclusion Criteria (before randomization):
• Occurrence of any severe surgical complication that require resuscitation or deviation from the planned surgical procedure. • Disseminated intravascular coagulopathy (DIC) • Application of any topical hemostatic material on the resection surface of the liver prior to application of the study treatment • Radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary hemostatic treatment |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of subjects with intraoperative hemostasis at 4 minutes. Time recording will start with treatment application. Hemostasis must be maintained until surgical closure. |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | Yes |
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 |
manual compression with a surgical swab |
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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 | 7 |
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
|
end-of-study (30 +/- 10 days after surgery). Screening can be performed at latest on the day of the baseline visit, i.e. the procedures of these two visits can be done on the same day. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |