CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 102 enrolled
Drug / intervention
EVARREST® Fibrin Sealant Patch +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01993888
NCT01993888Phase 3Completed
CompareCT.gov

A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST® Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery

Ethicon, Inc.·interventional·Posted Nov 25, 2013·Updated Jul 11, 2016

In Brief

A Phase 3 clinical trial evaluating EVARREST® Fibrin Sealant Patch and Standard of Care (SoC) for Hemorrhage. Completed, enrolled 102 participants across 17 sites in 4 countries.

Detailed Summary

To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhage
CountriesAustralia, New Zealand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 25, 2013
Enrollment StartOct 1, 2013
Primary CompletionJul 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.6 years ago

Interventions

EVARREST® Fibrin Sealant Patchbiological

Standard of Care (SoC)other