CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
EVARREST™ +2 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/NCT01681030
NCT01681030Phase 2Completed
CompareCT.gov

A Randomized, Controlled, Comparative Phase II Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery

Ethicon, Inc.·interventional·Posted Sep 7, 2012·Updated Jun 12, 2018

In Brief

A Phase 2 clinical trial evaluating EVARREST™, Topical hemostat, and 1 other intervention for Cardiovascular Disease. Completed, enrolled 42 participants across 6 sites.

Detailed Summary

This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 7, 2012
Enrollment StartAug 1, 2012
Primary CompletionAug 1, 2013
Study CompletionSep 3, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.8 years ago

Interventions

EVARREST™biological

EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).

Topical hemostatbiological

Equine collagen with Human Fibrinogen and Human Thrombin

Standard of Careother

SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.