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

Ethicon

Status and phase: Completed; Phase 3

Conditions: Controlling Mild to Moderate Bleeding During Surgery

Treatments: Biological: EVARREST® Fibrin Sealant Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT03255174

BIOS-16-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 28 days to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

EVARREST® Fibrin Sealant Patch

Experimental group

Description:

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.

Treatment:

Biological: EVARREST® Fibrin Sealant Patch