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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The objective of this controlled, non-randomized, single-center pilot study (CoSeal arm prospective)study is to evaluate the efficacy of the synthetic surgical hydrogel CoSeal® in the prevention of cardiac adhesion formation in patients submitted to VAD procedures.
In the past decade the use of ventricular assist devices) (VADs) for bridging to heart transplantation (HTx) or, in some cases, to recovery of the ventricular function has increased and, during the same time, the duration of the implantation period has lengthened dramatically. When removing VADs after a long period, surgeons face severe pericardial adhesions at the mediastinum level and of the surrounding tissue due to the inflammatory response. During resternotomy, dissection of these adhesions increases surgical time and can be a source of lesions on the cardiac or vascular structures and of severe bleeding at the moment of transplantation or when the device is removed.
Many products have been used to prevent or reduce adhesions but an ideal antiadhesive treatment has remained elusive. CoSeal®, a licensed synthetic hydrogel (Baxter, USA) has been shown to reduce pericardial adhesions in a limited series of reoperations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoSeal Group | Subjects with indication for LVAD implantation, meeting the requirements for LVAD implantation. Patients for whom LVAD removal is anticipated not earlier than 6 weeks after LVAD implantation. | ||
| CoSeal Control Group | Subjects who had a LVAD for more than 6 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence and severity of adhesions | Assessment of adhesions using a scoring system, assessing six different sites. | At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation) |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | Hemostasis time (START: off pump time; STOP: skin closure); bleeding volume Tansfusions of blood related products - defined as quantity of blood related product transfusions (ml) administered to the patient from skin incision to discharge or 30 days after surgery, whichever comes first, for both first and second study operation Blood loss in chest drains - defined as amount of blood lost in the chest drains from postoperative time to discharge or 30 days after surgery, whichever comes first. |
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Inclusion criteria (CoSeal group):
Inclusion criteria (CoSeal control group):
Exclusion criteria (CoSeal group):
Exclusion criteria (Co Seal control group):
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Patients with end stage heart failure, awaiting heart transplantion, with need for VAD (ventricular assist device)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roland Hetzer, MD, PhD | Contact | ++49/30/4593 2000 | hetzer@dhzb.de | |
| Thomas Krabatsch, MD, PhD | Contact | ++49/30/4593 2000 | krabatsch@dhzb.de |
| Name | Affiliation | Role |
|---|---|---|
| Roland Hetzer, MD, PhD | Deutsches Herzzentrum Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum Berlin | Recruiting | Berlin | 13353 | Germany |
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| Label | URL |
|---|---|
| Homepage of Deutsches Herzzentrum Berlin | View source |
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| At the moment of VAD-Removal/Transplantation |
| Clinical outcome | Surgery times (duration) during explantation/transplantation
| At the moment of VAD removal/transplantation (>6 weeks after VAD implantation) |
| Adhesion related |
| At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation) |