Clinical trial NCT01605019: The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Ventricular Dysfunction
Keywords: Ventricular Assist Devices
Heart assist pumps
heart pumps
sealant agents
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2012-05-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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.

Primary outcomes:
measure: Number of Participants With Reduced Bleeding Following the Implantation of a LVAD
timeFrame: Participants will be follwed for the duration of hospital stay for LVAD implant, typically an average of 1-4 weeks.
Secondary outcomes:
measure: 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
timeFrame: 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
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital DeBakey Heart & Vascular Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Brian A Bruckner, MD
role: PRINCIPAL_INVESTIGATOR
References: