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Trial record 59 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study

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ClinicalTrials.gov Identifier: NCT02227706
Recruitment Status : Recruiting
First Posted : August 28, 2014
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

Brief Summary:
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.

Condition or disease Intervention/treatment Phase
Hemorrhage Soft Tissue Bleeding Biological: EVICEL® Fibrin Sealant Device: SURGICEL® Absorbable Hemostat Phase 4

Detailed Description:

This is a prospective, randomized, controlled, clinical study comparing EVICEL® to SURGICEL®, as an adjunct to haemostasis when conventional methods of controlling bleeding are ineffective or impractical during surgery in paediatric patients.

At least 40 qualified paediatric subjects with an appropriate mild or moderate Target Bleeding Site (TBS) will be randomized in a 1:1 allocation ratio to either EVICEL® or SURGICEL®. Haemostasis will be assessed at 4, 7 and 10 minutes from randomization.

Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first group enrolled will include at least 36 subjects aged ≥1 years to <18 years of age. When enrolment of the first group is complete; enrolment of a subsequent group will commence and include at least 4 subjects from birth (including neonates ≤37 weeks gestation) to <1 years of age.

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 EVICEL® Fibrin Sealant as an Adjunct to Haemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery in Paediatric Patients
Actual Study Start Date : August 1, 2014
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EVICEL® Fibrin Sealant
EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product
Biological: EVICEL® Fibrin Sealant
EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product
Other Name: EVICEL, fibrin sealant

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® Absorbable Hemostat
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) 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: Intraoperatrive ]

Secondary Outcome Measures :
  1. Hemostasis at 4 minutes following randomization [ Time Frame: Intraoperative ]
  2. Hemostasis at 7 minutes following randomization [ Time Frame: Intraoperative ]
  3. Hemostasis at 10 minutes following randomization [ Time Frame: Intraoperative ]
  4. Incidence of treatment failures [ Time Frame: Intraoperative ]
  5. Incidence of adverse events [ Time Frame: Intaoperative through the 30-day follow-up ]
  6. Proportion of subjects with no re-bleeding [ Time Frame: Intraoperative ]

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 [ 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. Summary of volume of blood and blood products transfusions [ Time Frame: Intraoperative through the 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 birth to <18 years of age, requiring non-emergent laparoscopic or open (through peritoneum or pleura) abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects ≥1 years to <18 years of age. ii) The next 4 subjects to be enrolled will be subjects birth to <1years of age.
  • The subject and/or subject's parent or legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. If possible, 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; and
  • Presence of an appropriate mild or moderate bleeding soft tissue or parenchymal organ Target Bleeding Site identified intra-operatively by the surgeon;

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, during the study is planned to participate in any other investigational device or drug trial 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;
  • Subjects with Target Bleeding Site in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
  • Anastomotic bleeding sites will not be considered for randomization.

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): NCT02227706


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 #31 Recruiting
Brussels, Belgium
Canada, Ontario
Clinical Investigation Site #42 Recruiting
Hamilton, Ontario, Canada
Clinical Investigation Site #40 Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Clinical Investigation Site #41 Recruiting
Montreal, Quebec, Canada
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 #27 Recruiting
London, United Kingdom, SE1 7EH
Clinical Investigation Site #23 Recruiting
London, United Kingdom
Clinical Investigation Site #26 Recruiting
London, United Kingdom
Clinical Investigation Site #25 Recruiting
Nottingham, United Kingdom, NG7 2UH
Clinical Investigation Site #24 Recruiting
Southampton, United Kingdom
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: NCT02227706     History of Changes
Other Study ID Numbers: 400-12-006
2013-003401-26 ( EudraCT Number )
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 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