Heart Failure, Ventricular Dysfunction
Conditions
Keywords
Ventricular Assist Devices, Heart assist pumps, heart pumps, sealant agents
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.
Interventions
DEVICECoSeal
3 - 8mls of Coseal
DEVICEBioGlue® Surgical Adhesive
Total amount applied - 8 mls
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reduced Bleeding Following the Implantation of a LVAD | 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. 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CoSeal Arm patient randomized to received Coseal during LVAD implantation
CoSeal: 3 - 8mls of Coseal | 0 |
| BioGlue® Surgical Adhesive BioGlue® Surgical Adhesive or use of no sealant application
BioGlue® Surgical Adhesive: Total amount applied - 8 mls | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | pt did not meet transplant endpoint | 3 | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 0 |
| other Total, other adverse events | 0 / 4 | 0 / 0 |
| serious Total, serious adverse events | 0 / 4 | 0 / 0 |
Outcome results
Primary
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
Time frame: Participants will be follwed for the duration of hospital stay for LVAD implant, typically an average of 1-4 weeks.
Population: no analysis was performed on the 4 subjects enrolled in the study - they did not complete study.
Secondary
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.
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
Population: Analysis not completed - study terminated due to funding pulled by sponsor