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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Heart Failure, Ventricular Dysfunction

Intervention / Treatment
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* Device: CoSeal
* Device: BioGlue® Surgical Adhesive


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoSeal Arm<br>patient randomized to received Coseal during LVAD implantation | Device: CoSeal<br>* 3 - 8mls of Coseal<br>|
| Placebo Comparator: BioGlue® Surgical Adhesive<br>BioGlue® Surgical Adhesive or use of no sealant application | Device: BioGlue® Surgical Adhesive<br>* Total amount applied - 8 mls<br>* Other names: Control - BioGlue® Surgical Adhesive or use of no sealant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Reduced Bleeding Following the Implantation of a LVAD | 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. Total output amounts for each chest tube (CT) will be collected every 24 hours until all chest tubes are discontinued. Additionally, the total number of blood transfusions required during the hospitalization to implant the LVAD will be collected | Participants will be follwed for the duration of hospital stay for LVAD implant, typically an average of 1-4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular Assist Devices, Heart assist pumps, heart pumps, sealant agents