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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative, from tbs identification to final fascial closure
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test how safe and effective a new medical product is at controlling bleeding during surgery in children.
Who is the study for?
This trial is for pediatric patients aged 1 month to <18 years needing non-emergency surgery for mild or moderate liver and soft tissue bleeding. It's not for kids with major arterial bleeding, pregnant adolescents, drug abusers, trauma surgery patients, those with certain pre-operative conditions, recent or upcoming COVID-19 vaccinations, participation in other trials without approval, intolerance to blood products or infected surgical sites.
What is being tested?
The study tests the safety and effectiveness of EVARREST Fibrin Sealant Patch as an additional method to control bleeding during certain types of open surgeries in children. The patch is applied directly to the site of bleeding during the procedure.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions related to blood product intolerances or complications from the patch failing to control bleeding adequately.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperative to 30 (+/- 14) days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative to 30 (+/- 14) days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Absolute time to hemostasis
Secondary study objectives
Hemostatic success at 10 minutes
Hemostatic success at 4 minutes
Incidence of adverse events that are potentially related to bleeding at the TBS
+5 moreSide effects data
From 2014 Phase 3 trial • 102 Patients • NCT0199388850%
Nausea
28%
Hypotension
28%
Constipation
26%
Pyrexia
26%
Vomiting
24%
Hypomagnesaemia
24%
Hypokalaemia
22%
Hypophosphataemia
16%
Musculoskeletal Pain
12%
Pruritus
12%
Hypertension
12%
Dizziness
10%
Pleural Effusion
10%
Procedural Pain
10%
Abdominal Pain
10%
Odema Peripheral
10%
Acites
10%
Insomnia
8%
Tachycardia
8%
Abdominal Pain Upper
8%
International Normalized Ratio Increased
8%
Anaemia
8%
Oedema
8%
Urine Output Decreased
8%
Blood Lactic Acid Increased
6%
Confusional State
6%
Hiccups
6%
Diarrhoea
6%
Leukocytosis
6%
Small Intestinal Obstruction
6%
Pneumonia
6%
Postoperative Ileus
6%
Wound Secretion
6%
Malnutrition
6%
Vitamin D Deficiency
6%
Pain
6%
Hallucination
6%
Atelectasis
6%
Dyspnoea
4%
Post-procedural Bile Leak
4%
Hypoxia
4%
Haematoma Infection
4%
Atrial Fibrillation
4%
Abdominal Distension
4%
Urinary Tract Infection
4%
Hyperkalaemia
4%
Back Pain
4%
Urinary Retention
2%
Decreased Appetite
2%
Hepatic Failure
2%
Abdominal Abscess
2%
Lethargy
2%
Ileus
2%
Intestinal Perforation
2%
Gastroenteritis
2%
Chemical Peritonitis
2%
Renal Failure Acute
2%
Orthostatic Hypotension
2%
Bradycardia
2%
Renal Failure
2%
Wound Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
EVARREST Fibrin Sealant Patch
Standard of Care (SoC)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EVARREST® Fibrin Sealant PatchExperimental Treatment1 Intervention
EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EVARREST® Fibrin Sealant Patch
2013
Completed Phase 3
~110
Find a Location
Who is running the clinical trial?
Ethicon, Inc.Lead Sponsor
92 Previous Clinical Trials
62,186 Total Patients Enrolled
3 Trials studying Hemostasis
459 Patients Enrolled for Hemostasis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to press the trial treatment firmly for at least 4 minutes after it is applied.I cannot tolerate blood products or components of the study product.I am a woman of childbearing age and I am not pregnant or nursing.I have been or will be vaccinated for COVID-19 around my surgery.I have large artery or vein injuries needing repair while keeping the blood vessel open.I have had major bleeding that needed stitches or a procedure to stop it.I am admitted for surgery due to an injury.My surgeon found issues that might stop me from being part of the study.My wound is severely infected.I am a baby aged between 28 days and less than 1 year.I am under 18 and need surgery that is not an emergency on my liver, abdomen, pelvis, or chest.My surgeon identified a suitable bleeding site during surgery.I am under 18 years old and among the first 31 to join.You are currently using alcohol or drugs excessively.My bleeding is near or in a bone area.
Research Study Groups:
This trial has the following groups:- Group 1: EVARREST® Fibrin Sealant Patch
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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