A study evaluating the effect of EVARREST® Fibrin Sealant Patch as an adjunct to haemostasis in controlling mild to moderate bleeding during open surgery in paediatric patients

Phase 1

• Conditions: Mild or moderate hepatic parenchyma or soft tissue bleeding duringopen, abdominal, retroperitoneal, pelvic and thoracic (non-cardiac) surgery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2019-004657-89-GB
• Lead Sponsor: Ethicon Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Pre-operative:
1. Pediatric 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 31 subjects to be enrolled will be subjects aged =1 year 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 pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the pediatric 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 TBS identification.
Are the trial subjects under 18? yes
Number of subjects for this age range: 35
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, of childbearing age (i.e. adolescent), who are pregnant or nursing;
3. Subject is currently participating or plan to participate in any other investigational device or drug study 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 EVARREST 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the safety and haemostatic effectiveness of the EVARREST® Fibrin Sealant Patch in controlling mild or moderate soft tissue and parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in paediatric patients.;Secondary Objective: not applicable;Primary end point(s): Absolute time to hemostasis defined as the absolute time elapsed from TBS (Target Bleeding Site) identification to the last moment in time at which detectable bleeding at the TBS is observed.;Timepoint(s) of evaluation of this end point: Starting from TBS identification to the last moment in time at which detectable bleeding at the TBS is observed