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Trial record 70 of 306 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study

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ClinicalTrials.gov Identifier: NCT02227992
Recruitment Status : Recruiting
First Posted : August 28, 2014
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue & parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in paediatric patients.

Condition or disease Intervention/treatment Phase
Hemorrhage Soft Tissue Bleeding Hepatic Parenchyma Bleeding Biological: EVARREST™ Sealant Matrix Device: SURGICEL® Phase 4

Detailed Description:

This is an open label, prospective, randomised, multicentre, controlled, clinical study comparing EVARREST to SURGICEL (oxidized regenerated cellulose (ORC)) (Control) as an adjunct to haemostasis when conventional methods of controlling mild or moderate bleeding are ineffective or impractical during surgery in paediatric patients.

At least 40 qualified paediatric subjects with an appropriate mild or moderate bleeding Target Bleeding Site (TBS) will be randomised in a 1:1 allocation ratio to either EVARREST or SURGICEL (control). Absolute time to haemostasis will be assessed as well as haemostasis at 4 and 10 minutes from randomisation.

Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first 36 subjects enrolled will be aged ≥1 years to <18 years of age. Enrolment of a subsequent group will include 4 subjects from 1 month (≥ 28 days from birth) to <1 year of age will follow. Ongoing safety assessment will ensure adequate safety monitoring occur during the staged enrolment.

Subjects will be followed post-operatively through hospital discharge and at 30 days (+/-14 days) post-surgery.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Study Evaluating the Safety and Effectiveness of EVARREST® Sealant Matrix in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (Non-cardiac) Surgery in Paediatric Patients
Actual Study Start Date : July 1, 2014
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EVARREST™ Sealant Matrix
EVARREST™ Sealant Matrix/Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
Biological: EVARREST™ Sealant Matrix
EVARREST® Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
Other Name: EVARREST™ Fibrin Sealant Patch

Active Comparator: SURGICEL® Absorbable Hemostat
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Device: SURGICEL®
SURGICEL® Absorbable Hemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Other Name: oxidized regenerated cellulose




Primary Outcome Measures :
  1. Absolute time to haemostasis [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving haemostatic success at 4 minutes following randomization [ Time Frame: intraoperative ]
  2. Proportion of subjects achieving haemostatic success at 10 minutes following randomization [ Time Frame: intraoperative ]
  3. Portion of subjects with no re-bleeding at the TBS [ Time Frame: intraoperative ]
  4. Incidence of adverse events that are potentially related to bleeding at the target bleeding site (TBS) [ Time Frame: Through 30-day follow-up ]
  5. Incidence of adverse events that are potentially related to thrombotic events [ Time Frame: Through the 30-day follow-up ]
  6. Incidence of re-treatment at the TBS [ Time Frame: Intraoperative ]
  7. Incidence of adverse events [ Time Frame: Through the 30-day follow-up ]

Other Outcome Measures:
  1. Summarization of Haemoglobin [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
  2. Summarization of Haematocrit [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
  3. Summarization of Platelets laboratory results [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
  4. Summarization of volume of blood loss [ Time Frame: Intraoperative ]
  5. Sumamry of volume of blood and blood products transfusions [ Time Frame: Intra-operative through 30-day follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Paediatric 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 36 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.
  • 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 paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric 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.
  • Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon;
  • Ability to firmly press trial treatment at TBS until 4 minutes after randomisation

Exclusion Criteria:

  • Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
  • Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing;
  • Subject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor;
  • Subjects who are known, current alcohol and/or drug abusers
  • Subjects admitted for trauma surgery
  • Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure.
  • Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
  • 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 the EVARREST™ or SURGICEL® to blood flow and pressure during healing and absorption of the product;
  • TBS with major arterial bleeding requiring suture or mechanical ligation;
  • 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): NCT02227992


Contacts
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Contact: Leonie Rynn, MD 908-218-2492 LRynn1@its.jnj.com

Locations
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Belgium
Clinical Investigation Site #32 Recruiting
Brussels, Belgium, 1020
Clinical Investigation Site #31 Recruiting
Gent, Belgium
United Kingdom
Clinical Investigation Site #21 Recruiting
Birmingham, United Kingdom
Clinical Investigation Site #22 Recruiting
Leeds, United Kingdom
Clinical Investigation Site #20 Recruiting
Liverpool, United Kingdom
Clinical Investigation Site #26 Recruiting
London, United Kingdom, SE1 7EH
Clinical Investigation Site #23 Completed
London, United Kingdom
Clinical Investigation Site #25 Recruiting
Nottingham, United Kingdom, NG7 2UH
Clinical Investigation Site #24 Recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Ethicon, Inc.
Investigators
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Study Director: Richard Kocharian, MD, PhD Ethicon, Inc.

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Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT02227992     History of Changes
Other Study ID Numbers: 400-12-004
2013-003557-24 ( EudraCT Number )
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Ethicon, Inc.:
Fibrin Sealant
Hemostatics
Coagulants
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants