The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/2/2018 |
| Start Date: | June 2012 |
| End Date: | March 2014 |
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.
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.
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.
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.
We found this trial at
2
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