Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
(funding for study stopped)
Information provided by (Responsible Party):
Brian A. Bruckner, M.D., The Methodist Hospital System Identifier:
First received: May 21, 2012
Last updated: April 6, 2015
Last verified: April 2015

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.

Condition Intervention
Heart Failure
Ventricular Dysfunction
Device: CoSeal
Device: BioGlue® Surgical Adhesive

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: A Multi-Center Clinical Pilot-Study to Evaluate the Performance of CoSeal in Reducing Post-Op Bleeding, Air Micro Emboli, and Cardiac Tissue Adhesions in Patients With Left Ventricular Assist Devices (LVADs)

Resource links provided by NLM:

Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • Ability to reduce bleeding following the implantation of a LVAD [ Time Frame: Participants will be follwed for the duration of hospital stay for LVAD implant, typically an average of 1-4 weeks. ]
    The Primary Objective of this prospective pilot study is to evaluate the use of CoSeal™ for its ability to reduce bleeding following the implantation of a LVAD.

Secondary Outcome Measures:
  • Evaluate the use of CoSeal for its ability to reduce micro emboli during the LVAD implant procedure and prevent tissue adhesions following the implantation of a LVAD [ Time Frame: Participants will be followed for duration of hospital stay, typically average of 1-4 weeks at time of LVAD surgery & again at time of heart transplant surgery ]

    During the LVAD implant surgery, TEE and Transcranial Doppler will be conducted before and after the LVAD implant/CoSeal™ administration to detect possible micro emboli in the left ventricle (TEE) and in the intra-cranial circulation (TCD).

    • Intra-operative evaluation of surgical adhesions during LVAD explantation/heart transplant.

Enrollment: 4
Study Start Date: June 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CoSeal Arm
patient randomized to received Coseal during LVAD implantation
Device: CoSeal
3 - 8mls of Coseal
Placebo Comparator: BioGlue® Surgical Adhesive
BioGlue® Surgical Adhesive or use of no sealant application
Device: BioGlue® Surgical Adhesive
Total amount applied - 8 mls
Other Name: Control - BioGlue® Surgical Adhesive or use of no sealant

Detailed Description:

This is a prospective, single-blind (subjects and surgeon evaluator are blinded), randomized, multi-center, pilot study which is designed to evaluate the effects of CoSeal™ when used during a surgical procedure to implant a LVAD. The study sample size is 30 subjects; subjects will be randomized in a 2:1 fashion, 20 subjects will be randomized to CoSeal™ in the Treatment Group and 10 subjects will be randomized to no sealant in the Control Group. Bioglue will be used in the control group, only if necessary.

The Primary Objective of this prospective pilot study is to evaluate the use of CoSeal™ for its ability to reduce bleeding following the implantation of a LVAD. The secondary objectives will evaluate the use of CoSeal for its ability to reduce micro emboli during the LVAD implant procedure and prevent tissue adhesions following the implantation of a LVAD.

CoSeal™ (Baxter, Deerfield, Ill., USA) is a synthetic hydrogel consisting of two solutions of high molecular weight of polyethylene glycol which are co-extruded with a liquid sodium phosphate buffer from a syringe housing unit. The device is approved by the FDA for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage and it has been shown to provide superior anastomatic suture line sealing. In 2005, the CoSeal™ medical device was also approved in Europe and Australia for use in patients undergoing cardiac surgery to prevent or reduce the incidence, severity, and extent of post-surgical adhesions.

Data from this study will not be used to support any labeling changes. This is a PI initiative study that was submitted and granted funding from Baxter Healthcare for data and publishing of study data.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject or the subject's legal representative has signed the IRB approved study informed consent.
  • Subject is greater than or equal to 18 years of age.
  • Subject has a known indication for implantation of a LVAD and meets the requirements for its implantation.
  • Subject who, in the opinion of the investigator, will not require removal of the LVAD earlier than 6 weeks after implantation.

Exclusion Criteria:

  • Subject requires the concomitant use of any other anti-adhesion product during LVAD implantation.
  • Subject has an immune system disorder, immuno-deficiencies, or immuno-suppression.
  • Subject has known hypersensitivity to the study device, CoSeal™, or any component of the study device.
  • Subject is currently participating in another clinical trial for adhesion prevention or sealing evaluation and/or who has received such an investigational drug or device within the previous 30 days.
  • Subject has previously undergone a LVAD implantation/explantation.
  • Subject is pregnant or currently breast-feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01605019

United States, Texas
Texas Heart Institute
Houston, Texas, United States, 77030
The Methodist Hospital DeBakey Heart & Vascular Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Principal Investigator: Brian A Bruckner, MD The Methodist Hospital Research Institute
  More Information

Responsible Party: Brian A. Bruckner, M.D., Assistant Professor, Division of Cardiac & Transplant Surgery., The Methodist Hospital System Identifier: NCT01605019     History of Changes
Other Study ID Numbers: Protocol# 00007027
BS11-000540 ( Other Identifier: Baxter Healthcare Grant BS11-000540 )
Study First Received: May 21, 2012
Last Updated: April 6, 2015

Keywords provided by The Methodist Hospital System:
Ventricular Assist Devices
Heart assist pumps
heart pumps
sealant agents

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases processed this record on April 24, 2017