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NCT03255174 · ClinicalTrials.gov registry record · Phase 3
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
A Phase 3 study of Controlling Mild to Moderate Bleeding During Surgery, sponsored by Ethicon.
- Completed
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
- 5
- Study locations
NCT03255174: Completed Phase 3 study of Controlling Mild to Moderate Bleeding During Surgery, sponsored by Ethicon.
NCT03255174 is a Phase 3 study of Controlling Mild to Moderate Bleeding During Surgery that has completed, run by Ethicon. The registered enrollment target is 35 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03255174, a Phase 3 study of Controlling Mild to Moderate Bleeding During Surgery, has completed, sponsored by Ethicon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
- 5
- Study locations
Study Summary
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.
Primary Outcome
Hemostasis was defined as no detectable bleeding at the TBS. Absolute time to hemostasis was defined as the absolute time elapsed from TBS identification to the last moment in time at which detectable bleeding at the TBS was observed. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression.
Conditions Studied
Interventions
- BIOLOGICAL EVARREST® Fibrin Sealant Patch
Study Locations (5)
Other
- Birmingham Chrildren's Hospital - Birmingham
- Newcastle upon Tyne Hospitals NHS Foundation Trust - Newcastle upon Tyne
- Southampton University Hospital - Southampton
Alabama
- University of Alabama Hospital - Birmingham
New York
- icahn School of Medicine at Mt Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-03-20 |
| Est. Completion | 2025-02-14 |
| Phase | Phase 3 |
What the finished NCT03255174 record still lists
NCT03255174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Controlling Mild to Moderate Bleeding During Surgery appearing as the primary indexed condition, and to 1 intervention - of which EVARREST® Fibrin Sealant Patch is the first listed.
NCT03255174 lists 5 locations in 3 states (Other, Alabama, New York).
Frequently Asked Questions
What is clinical trial NCT03255174 about?
NCT03255174 is a clinical study titled "The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study". The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric popula...
What is the current status of trial NCT03255174?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2018-03-20. Estimated completion is 2025-02-14.
What conditions does trial NCT03255174 study?
This clinical trial studies the following conditions: Controlling Mild to Moderate Bleeding During Surgery.
What interventions are being tested in trial NCT03255174?
The interventions under investigation include: EVARREST® Fibrin Sealant Patch (BIOLOGICAL).
Who is sponsoring clinical trial NCT03255174?
This trial is sponsored by Ethicon, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03255174 being conducted?
This trial has 5 study locations across Alabama, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03255174's enrollment target sits among peer trials
35 1903rd of 2000 higher than 96 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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