Purpose

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.

Condition

Eligibility

Eligible Ages
Under 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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) The first 31 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 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. 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

Phase
Phase 4
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Biological: 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.
    Other names:
    • EVARREST

Recruiting Locations

Children's National and nearby locations

Children's National Medical Center
Washington, District of Columbia 20010
Contact:
Anthony Sandler, M.D.
ASandler@childrensnational.org

More Details

NCT ID
NCT03255174
Status
Recruiting
Sponsor
Ethicon, Inc.

Study Contact

Richard Kocharian, M.D., Ph.D.
1 (908) 218-2013
rkochar1@its.jnj.com

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.

Enrollment will be staggered by age. The first group will include 31 subjects ≥1 years to <18 years of age and the subsequent group will include 4 subjects from 1 month (≥ 28 days from birth) to <1 years of age. Ongoing safety assessment will ensure adequate safety monitoring occur during the staged enrollment.

At least thirty-five (35) qualified pediatric subjects with an appropriate mild or moderate bleeding TBS will be enrolled in this study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.