E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects undergoing elective, open, hepatic surgery during which a resection plane is created and wherein an appropriate Target Bleeding Site is identified |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
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 safety and hemostatic effectiveness of EVARREST Fibrin Sealant Patch versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Subjects > 18 years of age, requiring elective or urgent, open hepatic surgery.
2. Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon;
3. Subjects must be willing to participate in the study, and provide written informed consent
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E.4 | Principal exclusion criteria |
1.Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
2.TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST™ to blood flow and pressure during healing and absorption of the product;
3. TBS with major arterial bleeding requiring suture or mechanical ligation;
4. Subjects admitted for trauma surgery;
5. Subject is a transplant patient for fulminant hepatic failure
6. Subject with TBS within an actively infected field;
7. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
8. Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
9. Subjects who are known, current alcohol and / or drug abusers;
10. Subjects who have participated in another medical device or investigational drug trial within 30 days of surgery;
11. Female subjects who are pregnant or nursing.
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure (latest point in time where EVARREST is visible to confirm hemostasis). Hemostasis is defined as no detectable bleeding at the TBS. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
4 minutes following randomization |
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E.5.2 | Secondary end point(s) |
Proportion of subjects achieving hemostatic success at 10 minutes following randomization (defined as achievement of hemostasis at 10 minutes and no further bleeding requiring re-treatment prior to wound closure);
Absolute time to hemostasis (defined as the absolute time to achieve hemostasis at or after 4 minutes from randomization);
Incidence of re-bleeding events from the TBS during the study follow-up;
Incidence of adverse events;
Incidence of adverse events that are potentially related to thrombotic events
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
For first secondary endpoint: 10 minutes. Other endpoints throughout study period. |
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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) | 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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 4 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
New Zealand |
United States |
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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
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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 | 1 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 | 1 |