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HemorrhagePhase 3NCT02227992

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

A Phase 3 study testing EVARREST™ Sealant Matrix and SURGICEL® in people with Hemorrhage and Soft Tissue Bleeding, run by Ethicon, Inc. at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 28 days to 17 years
What is being tested?
EVARREST™ Sealant Matrix and SURGICEL®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
10 sitesin 2 countries
Study dates
1 Jul 2014to 12 Nov 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 28 days to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United Kingdom7 sites

  • Clinical Investigation Site #21

    Birmingham

  • Clinical Investigation Site #22

    Leeds

  • Clinical Investigation Site #20

    Liverpool

  • Clinical Investigation Site #26

    London, SE1 7EH

  • Clinical Investigation Site #23

    London

  • Clinical Investigation Site #25

    Nottingham, NG7 2UH

  • Clinical Investigation Site #24

    Southampton, SO16 6YD

Other trials in United Kingdom

Belgium3 sites

  • Clinical Investigation Site #32

    Brussels, 1020

  • Investigative Site #30

    Genk

  • Clinical Investigation Site #31

    Ghent

Other trials in Belgium

About this study

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

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.

Read the 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.

Being tested
EVARREST™ Sealant Matrix, SURGICEL®
Keywords
Fibrin Sealant, Hemostatics, Coagulants
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EVARREST™ Sealant MatrixBiological

    Also called EVARREST™ Fibrin Sealant Patch

    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.

  • SURGICEL®Device

    Also called oxidized regenerated cellulose

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

Study groups in NCT02227992
Study groupRoleWhat they receive
EVARREST™ Sealant MatrixExperimentalEVARREST™ 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).
Receives: Biological: EVARREST™ Sealant Matrix
SURGICEL® Absorbable HemostatActive comparatorSURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Receives: Device: SURGICEL®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute Time to Haemostasis (TTH)

    Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed.

    Measured: Up to 1 day (Intraoperative)

  2. Absolute Time to Haemostasis (TTH) by Age Group

    Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed.

    Measured: Up to 1 day (Intraoperative)

Secondary outcomes (12)

  1. Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure

    Percentage of participants achieving haemostatic success at 4 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.

    Measured: 4 minutes post randomization (up to 1 day; intraoperative)

  2. Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure

    Percentage of participants achieving haemostatic success at 10 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.

    Measured: 10 minutes post randomization (up to 1 day; intraoperative)

  3. Percentage of Participants With No Re-bleeding at the Target Bleeding Site

    Percentage of participants with no re-bleeding at the TBS were reported.

    Measured: Up to 44 days post-surgery on Day 0

  4. Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS

    Number of participants With AEs that were potentially related to bleeding at the TBS were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measured: Up to 44 days post-surgery on Day 0

  5. Number of Participants With AEs That Were Potentially Related To Thrombotic Events

    Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measured: Up to 44 days post-surgery on Day 0

  6. Number of Participants Who Required Re-treatment At The Target Bleeding Site

    Number of participants who required re-treatment at the TBS were reported.

    Measured: Up to 44 days post-surgery on Day 0

  7. Number of Participants With Adverse Events

    An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measured: Up to 44 days post-surgery on Day 0

  8. Change From Baseline to Post-surgery in Haemoglobin

    Change from baseline to post-surgery in haemoglobin were reported.

    Measured: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)

  9. Change From Baseline to Post-surgery in Haematocrit

    Change from baseline to post-surgery in Haematocrit was reported.

    Measured: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)

  10. Change From Baseline to Post-surgery in Platelet Count

    Change from baseline to post-surgery in platelet count was reported.

    Measured: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)

  11. Estimated Volume of Blood Loss

    Estimated volume of intra-operative blood loss (including but not limited to the TBS) was reported.

    Measured: Up to 1 day (intraoperative)

  12. Number of Participants Who Received Blood Transfusions

    Number of participants who received blood transfusions (red blood cells [RBCs], whole blood, fresh frozen plasma, platelets, and cryoprecipitates) were reported.

    Measured: Up to 44 days post-surgery on Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2014 (estimated)
  2. Study start1 Jul 2014
  3. Primary completion27 Oct 2021
  4. Study completion12 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02227992
Sponsor's protocol ID
400-12-004
Other IDs
2013-003557-24
Status last verified
Oct 2022
First submitted
28 Jul 2014
Last updated
8 Sep 2023
Data monitoring committee
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EVARREST™ Sealant Matrix and SURGICEL® in people with Hemorrhage and Soft Tissue Bleeding, run by Ethicon, Inc. at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Time to Haemostasis (TTH) (time frame: Up to 1 day (Intraoperative)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02227992.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.

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