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Trial record 8 of 825 for:    Recruiting, Not yet recruiting, Available Studies | Bleeding

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

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ClinicalTrials.gov Identifier: NCT03255174
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Controlling Mild to Moderate Bleeding During Surgery Biological: EVARREST® Fibrin Sealant Patch Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study Evaluating the Safety and Effectiveness of EVARREST® Fibrin Sealant Patch in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (Non-cardiac) Surgery in Pediatric Patients
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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 Name: EVARREST




Primary Outcome Measures :
  1. Absolute time to hemostasis [ Time Frame: 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 :
  1. Hemostatic success at 4 minutes [ Time Frame: 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.

  2. Hemostatic success at 10 minutes [ Time Frame: 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.

  3. No re-bleeding at the TBS [ Time Frame: Intraoperative, from TBS identification to final fascial closure ]
    Proportion of subjects with no re-bleeding at the TBS.

  4. Incidence of adverse events that are potentially related to bleeding at the TBS [ Time Frame: Intraoperative to 30 (+/- 14) days ]
    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 [ Time Frame: Intraoperative to 30 (+/- 14) days ]
    Incidence of adverse events that are potentially related to thrombotic events.

  6. Incidence of re-treatment at the TBS [ Time Frame: Intraoperative, from TBS identification to final fascial closure ]
  7. Incidence of Adverse Events [ Time Frame: Intraoperative to 30 (+/- 14) days ]


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255174


Contacts
Contact: Richard Kocharian, M.D., Ph.D. 1 (908) 218-2013 rkochar1@its.jnj.com
Contact: Heather Paleczny, B.S. CCRA 1 (908) 218-2081 hpaleczn@its.jnj.com

Locations
United States, Alabama
University of Alabama Hospital Recruiting
Birmingham, Alabama, United States, 35222
Contact: Beierle A Elizabeth, M.D.    205-638-9688    Elizabeth.Beierle@childrensal.org   
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Anthony Sandler, M.D.       ASandler@childrensnational.org   
United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: Michael J Millis, M.D.    773-702-7511    mmillis@surgery.bsd.uchicago.edu   
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Joseph A Draus, M.D., M.B.A.    859-323-5289    John.Draus@uky.edu   
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Jennifer Aldrink, M.D.    614-722-2650    Jennifer.Aldrink@nationwidechildrens.org   
Sponsors and Collaborators
Ethicon, Inc.

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT03255174     History of Changes
Other Study ID Numbers: BIOS-16-001
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Efficacy and safety results related to the primary and secondary endpoints

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ethicon, Inc.:
Bleeding, hemostasis, re-bleeding, hemostatic

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants