Study Stopped
funding for study stopped
The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery
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)
2 other identifiers
interventional
4
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jun 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 24, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
August 31, 2018
CompletedAugust 31, 2018
August 1, 2018
1.7 years
May 21, 2012
September 12, 2016
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
CoSeal Arm
EXPERIMENTALpatient randomized to received Coseal during LVAD implantation
BioGlue® Surgical Adhesive
PLACEBO COMPARATORBioGlue® Surgical Adhesive or use of no sealant application
Interventions
Total amount applied - 8 mls
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Texas Heart Institute
Houston, Texas, 77030, United States
The Methodist Hospital DeBakey Heart & Vascular Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Only 4 subjects were enrolled in study prior to study being closed due to funding being pulled by grant sponsor. Data was collected on their surgery and recovery but not analyzed due to limited sample size.
Results Point of Contact
- Title
- Raquel R Bunge
- Organization
- Houston Methodist Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Brian A Bruckner, MD
The Methodist Hospital Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Division of Cardiac & Transplant Surgery.
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 24, 2012
Study Start
June 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
August 31, 2018
Results First Posted
August 31, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share
Data sharing plan to be determined.