E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild or moderate hepatic parenchyma or soft tissue bleeding during
open, abdominal, retroperitoneal, pelvic and thoracic (non-cardiac) surgery |
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E.1.1.1 | Medical condition in easily understood language |
abdominal, retroperitoneal, pelvic and non-cardiac surgery |
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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 |
The objective of this study is to evaluate the safety and haemostatic effectiveness of the EVARREST® Fibrin Sealant Patch in controlling mild or moderate bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in paediatric patients. |
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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 |
Pre-Operative:
Paediatric subjects aged ≥28 days (≥ 1 month) to <18 years, requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures;
i) The first 36 subjects to be enrolled will be subjects aged ≥ 1 years to <18 years.
ii) The next 4 subjects to be enrolled will be subjects aged ≥28 days to < 1 year.
2. The subject’s parent/legal guardian must be willing to give permission for the subject to participate in the trial, and provide written Informed Consent for the subject. In addition, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian’s written Informed Consent for the subject will be acceptable for the subject to be included in the study.
Intra-Operative:
3. Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon;
4. Ability to firmly press trial treatment at TBS until 4 minutes after randomisation;
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E.4 | Principal exclusion criteria |
Pre-Operative:
1. Subjects with known intolerance to blood products or to one of the components of the
study product or is unwilling to receive blood products;
2. Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or
nursing;
3. Subject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor;
4. Subjects who are known, current alcohol and/or drug abusers
5. Subjects admitted for trauma surgery
6. Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure.
Intra-Operative:
7. Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
8. 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 the EVARREST™ or SURGICEL® to blood flow and pressure during healing and absorption of the product;
9. TBS with major arterial bleeding requiring suture or mechanical ligation;
10. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Absolute time to haemostasis defined as the absolute time elapsed from randomisation to the last moment in time at which detectable bleeding at the TBS is observed. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Starting from randomisation to the last moment in time at which detectable bleeding at the TBS is observed |
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E.5.2 | Secondary end point(s) |
1. Proportion of subjects achieving haemostatic success at 4 minutes following randomisation and no bleeding requiring treatment at the TBS occurs any time prior to final fascial closure
2. Proportion of subjects achieving haemostatic success at 10 minutes following randomisation and no bleeding requiring treatment at the TBS occurs any time prior to final fascial closure
3. Portion of subjects with no re-bleeding at the TBS
4. Incidence of adverse events that are potentially related to bleeding at the TBS
5. Incidence of adverse events that are potentially related to thrombotic events
6. Incidence of re-treatment at the TBS
7. Incidence of adverse events
8. Summarization of Haemoglobin, Haematocrit, Platelets laboratory results, volume of blood loss, & volume of blood and blood products transfusions |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 4 minutes following treatment application and through to the end of surgical procedure
2. 10 minutes following treatment application and through to the end of surgical procedure
3. From randomisation to the end of surgical procedure
4. From randomisation through 30 day follow up visit
5. From randomisation through 30 day follow up visit
6. From randomisation to the end of surgical procedure
7. From randomisation through 30 day follow up visit
8. From baseline through 30 day follow up visit |
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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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
medical device - SURGICEL® absorbable hemostat |
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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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 | No |
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 | 6 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |