The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study

NCT ID: NCT02227706

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-01
• Study Completion Date: 2019-05-17

Brief Summary

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

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.

Conditions

Hemorrhage; Soft Tissue Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

EVICEL® Fibrin Sealant

Intervention Type: BIOLOGICAL

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

SURGICEL® Absorbable Hemostat

SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.

Group Type: ACTIVE_COMPARATOR

SURGICEL® Absorbable Hemostat

Intervention Type: DEVICE

SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.

Interventions

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

Intervention Type: BIOLOGICAL

SURGICEL® Absorbable Hemostat

SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.

Intervention Type: DEVICE

Other Intervention Names

EVICEL, fibrin sealant; oxidized regenerated cellulose

Eligibility 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.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Kocharian, MD, PhD

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

Clinical Investigation Site #31

Brussels, , Belgium

Clinical Investigation Site #42

Hamilton, Ontario, Canada

Clinical Investigation Site #40

Toronto, Ontario, Canada

Clinical Investigation Site #41

Montreal, Quebec, Canada

Clinical Investigation Site #21

Birmingham, , United Kingdom

Clinical Investigation Site #22

Leeds, , United Kingdom

Clinical Investigation Site #20

Liverpool, , United Kingdom

Clinical Investigation Site #27

London, , United Kingdom

Clinical Investigation Site #23

London, , United Kingdom

Clinical Investigation Site #26

London, , United Kingdom

Clinical Investigation Site #30

Newcastle, , United Kingdom

Clinical Investigation Site #25

Nottingham, , United Kingdom

Clinical Investigation Site #24

Southampton, , United Kingdom

Countries

Belgium; Canada; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2013-003401-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

400-12-006

Identifier Type: -

Identifier Source: org_study_id