The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery
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.
|Heart Failure Ventricular Dysfunction||Device: CoSeal Device: BioGlue® Surgical Adhesive|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)|
- 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.
- 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.
|Study Start Date:||June 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: CoSeal Arm
patient randomized to received Coseal during LVAD implantation
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
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.
Please refer to this study by its ClinicalTrials.gov 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|
|Principal Investigator:||Brian A Bruckner, MD||The Methodist Hospital Research Institute|