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Standard of Care for Bleeding (EVARREST Trial)

Phase 4
Waitlist Available
Research Sponsored by Ethicon, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative
Awards & highlights

EVARREST Trial Summary

The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal (stomach area), retroperitoneal (hip and stomach area), pelvic (hip area) and non-cardiac thoracic (chest area) surgery.

Eligible Conditions
  • Bleeding
  • Soft tissue hemorrhage

EVARREST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety Parameter - Incidence of Increase Blood Fibrinogen Level
Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS)
Safety Parameter - Incidence of Thromboembolic Events
Other outcome measures
This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site.
This Product is Easy to Apply to a Variety of Bleeding Sites.
This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

EVARREST Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of CareExperimental Treatment1 Intervention
Standard of Care (SoC) is manual compression with or without a topical absorbable hemostat.
Group II: EVARREST™ Fibrin Sealant PatchActive Control1 Intervention
EVARREST™ Fibrin Sealant Patch consists of human fibrinogen and human thrombin embedded in a flexible composite patch component.

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Who is running the clinical trial?

Ethicon, Inc.Lead Sponsor
91 Previous Clinical Trials
60,171 Total Patients Enrolled
Richard Kocharian, MDStudy DirectorEthicon, Inc.
3 Previous Clinical Trials
616 Total Patients Enrolled
~12 spots leftby Jul 2025
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