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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal 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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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

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.

Find a Location

Who is running the clinical trial?

Ethicon, Inc.Lead Sponsor
92 Previous Clinical Trials
62,071 Total Patients Enrolled
Richard Kocharian, MDStudy DirectorEthicon, Inc.
3 Previous Clinical Trials
616 Total Patients Enrolled
~12 spots leftby Nov 2025
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