The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study

Phase 3

Completed

• Conditions: Controlling Mild to Moderate Bleeding During Surgery
• Interventions: Biological: EVARREST® Fibrin Sealant Patch

• Registration Number: NCT03255174
• Lead Sponsor: Ethicon, Inc.

Brief Summary

The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.

Detailed Description

This is an open-label, multicenter, single-arm study evaluating the safety and effectiveness of EVARREST in controlling mild or moderate bleeding in hepatic parenchyma or soft tissue for which standard methods of achieving hemostasis are ineffective or impractical.

Eligible subjects will be treated with EVARREST. Subjects will be followed post-operatively through discharge and at 30 days (+/-14 days) post-surgery.

At least thirty-five pediatric subjects with an appropriate mild or moderate bleeding target bleeding site (TBS) will be enrolled in this study. The age of the subjects enrolled in the study will be from 1 month to less than (\<) 18 years. This will include a minimum of 4 subjects aged 1 month (greater than or equal to \[\>=\] 28 days from birth) to \<1 year.

Study Timeline

• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-21
• Study Start: 2018-03-20
• Primary Completion: 2025-01-22
• Study Completion: 2025-02-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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) A minimum of 4 subjects to be enrolled will be 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.
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.

Exclusion Criteria

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
7. Subjects that have received a COVID-19 vaccine either 4 weeks prior to surgery or scheduled to receive COVID-19 vaccine within the 30-day follow-up period
8. Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
9. 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
10. TBS with major arterial bleeding requiring suture or mechanical ligation;
11. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EVARREST® Fibrin Sealant Patch	EVARREST® Fibrin Sealant Patch	EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.

Primary Outcome Measures

Name	Time	Method
Absolute time to hemostasis	Intraoperative from TBS identification to the last moment in time at which no detectable bleeding at the TBS is observed	The absolute time to hemostasis, defined as the absolute time elapsed from TBS identification to the last moment in time at which detectable bleeding at the TBS is observed.

Secondary Outcome Measures

Name	Time	Method
No re-bleeding at the TBS	Intraoperative, from TBS identification to final fascial closure	Proportion of subjects with no re-bleeding at the TBS.
Number of Participants with Abnormalities in Clinical Laboratory Tests	Intraoperative to 30 days	Number of participants with abnormalities in clinical laboratory tests (hemoglobin, hematocrit, and platelets) will be reported.
Hemostatic success at 4 minutes	Intraoperative, 4 minutes after TBS identification	Proportion of subjects achieving hemostatic success at 4 minutes following Target Bleeding Site (TBS) identification and no bleeding requiring treatment at the TBS any time prior to final fascial closure.
Incidence of adverse events that are potentially related to bleeding at the TBS	Intraoperative to 30 (+/- 14) days	Incidence of adverse events that are potentially related to bleeding at the TBS.
Incidence of adverse events that are potentially related to thrombotic events	Intraoperative to 30 (+/- 14) days	Incidence of adverse events that are potentially related to thrombotic events.
Number of Participants with Estimated Intraoperative Blood Loss	Intraoperative to 30 days	Number of participants with estimated intraoperative blood loss will be reported.
Hemostatic success at 10 minutes	Intraoperative, 10 minutes after TBS identification	Proportion of subjects achieving hemostatic success at 10 minutes following TBS identification and no bleeding requiring treatment at the TBS any time prior to final fascial closure.
Incidence of re-treatment at the TBS	Intraoperative, from TBS identification to final fascial closure
Incidence of Adverse Events	Intraoperative to 30 (+/- 14) days
Number of Participants with Blood products Transfused	Intraoperative to 30 days	Number of participants with blood products transfused will be reported.

Trial Locations

Locations (5)

University of Alabama Hospital; 🇺🇸 Birmingham, Alabama, United States

icahn School of Medicine at Mt Sinai; 🇺🇸 New York, New York, United States

Birmingham Chrildren's Hospital; 🇬🇧 Birmingham, United Kingdom

Newcastle upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle upon Tyne, United Kingdom

Southampton University Hospital; 🇬🇧 Southampton, United Kingdom