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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The Methodist Hospital System
Sponsor:
Information provided by (Responsible Party):
Brian A. Bruckner, M.D., The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01605019
First received: May 21, 2012
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01605019

Contacts
Contact: Raquel R Bunge, RN, BSN 713-441-6509 rrbunge2@tmhs.org

Locations
United States, Texas
Texas Heart Institute Not yet recruiting
Houston, Texas, United States, 77030
Contact: Isabella Candelaria    832-355-6594    icandelaria@texasheart.org   
Principal Investigator: O.H. (Bud) Frazier, MD         
The Methodist Hospital DeBakey Heart & Vascular Center Recruiting
Houston, Texas, United States, 77030
Contact: Raquel R Bunge, RN, BSN    713-441-6509    rrbunge@@tmhs.org   
Principal Investigator: Brian A Bruckner, MD         
Sponsors and Collaborators
The Methodist Hospital System
Investigators
Principal Investigator: Brian A Bruckner, MD The Methodist Hospital Research Institute
  More Information

No publications provided

Responsible Party: Brian A. Bruckner, M.D., Assistant Professor, Division of Cardiac & Transplant Surgery., The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01605019     History of Changes
Other Study ID Numbers: Protocol# 00007027, BS11-000540
Study First Received: May 21, 2012
Last Updated: August 1, 2013
Health Authority: United States: Institutional Review Board

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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 20, 2014