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The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery

NCT01605019 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-08-31

Study results available
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Summary

The purpose of this study is to evaluate the use of a device called CoSeal™. CoSeal™ is an FDA approved synthetic (man-made) surgical sealant which is currently used to help stop leaks in blood vessels during surgery.

This study is evaluating CoSeal™ when it is applied to various areas of the heart during the surgery to implant a Left Ventricular Assist Device (LVAD). the investigators are looking for evidence which indicates that CoSeal™ may be useful in reducing or stopping bleeding, the occurrence of micro emboli (small particles of air or blood), and the formation of cardiac adhesions (scar tissue strands that may form around the heart in the area of a previous LVAD operation) in patients who undergo LVAD implantation surgery.

Conditions

Interventions

DEVICE

CoSeal

3 - 8mls of Coseal

DEVICE

BioGlue® Surgical Adhesive

Total amount applied - 8 mls

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Brian A Bruckner, MD · The Methodist Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-03-31
Completion
2014-03-31

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 NCT01605019 on ClinicalTrials.gov