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The Fibrin Pad Cardiovascular Study

NCT01681030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-06-12

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

EVARREST™

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).

BIOLOGICAL

Topical hemostat

Equine collagen with Human Fibrinogen and Human Thrombin

OTHER

Standard of Care

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.

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Jerome Riebman, MD · Ethicon, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-01
Primary Completion
2013-08-01
Completion
2013-09-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01681030 on ClinicalTrials.gov