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

May 21, 2012
August 1, 2013
June 2012
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01605019 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery
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)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Heart Failure
  • Ventricular Dysfunction
  • Device: CoSeal
    3 - 8mls of Coseal
    Other Name: CoSeal
  • Device: BioGlue® Surgical Adhesive
    Total amount applied - 8 mls
    Other Name: Control - BioGlue® Surgical Adhesive or use of no sealant
  • Experimental: CoSeal Arm
    patient randomized to received Coseal during LVAD implantation
    Intervention: Device: CoSeal
  • Placebo Comparator: BioGlue® Surgical Adhesive
    BioGlue® Surgical Adhesive or use of no sealant application
    Intervention: Device: BioGlue® Surgical Adhesive
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
October 2015
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Raquel R Bunge, RN, BSN 713-441-6509 rrbunge2@tmhs.org
United States
 
NCT01605019
Protocol# 00007027, BS11-000540
No
Brian A. Bruckner, M.D., The Methodist Hospital System
The Methodist Hospital System
Not Provided
Principal Investigator: Brian A Bruckner, MD The Methodist Hospital Research Institute
The Methodist Hospital System
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP