NCT02227706

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2014

Longer than P75 for phase_3

Geographic Reach
3 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2019

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 31, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

4.7 years

First QC Date

August 26, 2014

Results QC Date

April 10, 2020

Last Update Submit

August 14, 2020

Conditions

HemorrhageSoft Tissue Bleeding

Keywords

Fibrin SealantHemostaticsCoagulants

Outcome Measures

Primary Outcomes (1)

  • Absolute Time to Haemostasis

    Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS).

    From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])

Secondary Outcomes (16)

  • Number of Participants Achieving Haemostasis at 4 Minutes

    Intra-operatively from randomisation to 4 minutes after randomisation

  • Number of Participants Achieving Haemostasis at 7 Minutes

    Intra-operatively from randomisation to 7 minutes after randomisation

  • Number of Participants Achieving Haemostasis at 10 Minutes

    Intra-operatively from randomisation to 10 minutes after randomisation

  • Incidence of Treatment Failures (Number of Participants)

    10 minutes

  • Estimated Blood Loss

    During surgical procedure (first incision to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])

  • +11 more secondary outcomes

Other Outcomes (2)

  • Number of Participants With a Thrombotic Event

    From randomisation up to 30 days (+/- 14 days) following surgery

  • Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site

    From randomisation to 30 days (+/- 14 days) following surgery

Study Arms (2)

EVICEL® Fibrin Sealant

EXPERIMENTAL

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

SURGICEL® Absorbable Hemostat

ACTIVE COMPARATOR

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

Device: SURGICEL® Absorbable Hemostat

Interventions

EVICEL® Fibrin SealantBIOLOGICAL

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

Also known as: EVICEL, fibrin sealant
EVICEL® Fibrin Sealant
SURGICEL® Absorbable HemostatDEVICE

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

Also known as: oxidized regenerated cellulose
SURGICEL® Absorbable Hemostat

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Clinical Investigation Site #31

Brussels, Belgium

Location

Clinical Investigation Site #42

Hamilton, Ontario, Canada

Location

Clinical Investigation Site #40

Toronto, Ontario, Canada

Location

Clinical Investigation Site #41

Montreal, Quebec, Canada

Location

Clinical Investigation Site #21

Birmingham, United Kingdom

Location

Clinical Investigation Site #22

Leeds, United Kingdom

Location

Clinical Investigation Site #20

Liverpool, United Kingdom

Location

Clinical Investigation Site #27

London, SE1 7EH, United Kingdom

Location

Clinical Investigation Site #23

London, United Kingdom

Location

Clinical Investigation Site #26

London, United Kingdom

Location

Clinical Investigation Site #30

Newcastle, United Kingdom

Location

Clinical Investigation Site #25

Nottingham, NG7 2UH, United Kingdom

Location

Clinical Investigation Site #24

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Patricia Schleckser
Organization
ETHICON Inc
pschleck@its.jnj.com
9082182244

Study Officials

  • Richard Kocharian, MD, PhD

    Ethicon, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 28, 2014

Study Start

August 1, 2014

Primary Completion

April 17, 2019

Study Completion

May 17, 2019

Last Updated

August 31, 2020

Results First Posted

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

Locations

GB(9)CA(3)BE(1)