Heart FailureNCT01605019
The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery
A study testing CoSeal and BioGlue® Surgical Adhesive in people with Heart Failure and Ventricular Dysfunction, run by The Methodist Hospital Research Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ventricular Dysfunction
- What is being tested?
- CoSeal and BioGlue® Surgical Adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Heart Institute
Houston, Texas, 77030
The Methodist Hospital DeBakey Heart & Vascular Center
Houston, Texas, 77030
About this study
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)
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.
Read the 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.
- Conditions
- Heart Failure, Ventricular Dysfunction
- Being tested
- CoSeal, BioGlue® Surgical Adhesive
- Keywords
- Ventricular Assist Devices, Heart assist pumps, heart pumps, sealant agents
- Medical subject headings
- Heart Failure, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoSealDevice
3 - 8mls of Coseal
BioGlue® Surgical AdhesiveDevice
Also called Control - BioGlue® Surgical Adhesive or use of no sealant
Total amount applied - 8 mls
| Study group | Role | What they receive |
|---|---|---|
| CoSeal Arm | Experimental | patient randomized to received Coseal during LVAD implantation Receives: Device: CoSeal |
| BioGlue® Surgical Adhesive | Placebo comparator | BioGlue® Surgical Adhesive or use of no sealant application Receives: Device: BioGlue® Surgical Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: funding for study stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian A. Bruckner, M.D., The Methodist Hospital Research Institute
- Investigators
- Brian A Bruckner, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605019
- Sponsor's protocol ID
- Pro00007027
- Other IDs
- BS11-000540
- Status last verified
- Aug 2018
- First submitted
- 21 May 2012
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Data sharing plan to be determined.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01605019
- Acronym / sponsor ID
- Pro00007027
- Conditions
- Heart Failure, Ventricular Dysfunction
- Keywords
- Ventricular Assist Devices, Heart assist pumps, heart pumps, sealant agents
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding for study stopped
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 May 2012 (estimated)
- Results
- Posted 31 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoSeal Arm | Experimental | Device: CoSealpatient randomized to received Coseal during LVAD implantation |
| BioGlue® Surgical Adhesive | Placebo comparator | Device: BioGlue® Surgical AdhesiveBioGlue® Surgical Adhesive or use of no sealant application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoSeal3 - 8mls of Coseal | Device | CoSeal Arm |
| BioGlue® Surgical AdhesiveAlso: Control - BioGlue® Surgical Adhesive or use of no sealantTotal amount applied - 8 mls | Device | BioGlue® Surgical Adhesive |
Primary outcome
Number of Participants With Reduced 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. 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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data sharing plan to be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian A Bruckner, MD principal investigator
The Methodist Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoSeal and BioGlue® Surgical Adhesive in people with Heart Failure and Ventricular Dysfunction, run by The Methodist Hospital Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Reduced 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.