End-stage Heart Failure Awaiting VAD Implantation Clinical Trial
— COVADISOfficial title:
A Controlled, Single-Center Clinical Pilot Study to Evaluate the Performance of CoSeal as a Barrier for Adhesion Prevention in Patients Submitted to Ventricular Assist Device VAD)
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | February 2018 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion criteria (CoSeal group): 1. Written informed consent obtained from the subject prior to participation in the study 2. At least 18 years of age 3. Subjects with indication for LVAD implantation, meeting the requirements for LVAD implantation. Patients for whom the investigator anticipates LVAD removal not earlier than 6 weeks after LVAD implantation. Inclusion criteria (CoSeal control group): 1. Written informed consent obtained from the subject prior to participation in the study 2. At least 18 years of age 3. Subjects who had a LVAD for more than 6 weeks. Exclusion criteria (CoSeal group): 1. Concomitant use of any other anti-adhesion product 2. Immune system disorders, immuno-deficiencies or immuno-suppression 3. Known hypersensitivity to components of the study product 4. Patients concurrently participating in another clinical trial for adhesion prevention or sealing evaluation and having received such an investigational drug or device within the previous 30 days 5. Patients who were previously subject to another LVAD implantation/explantation 6. Pregnant or breast-feeding women. Exclusion criteria (Co Seal control group): 1. Known use of any other anti-adhesion product during VAD implantation 2. Immune system disorders, immuno-deficiencies or immuno-suppression 3. Patients concurrently participating in another clinical trial for adhesion prevention or sealing evaluation and having received such an investigational drug or device within the previous 30 days 4. Patients who were previously subject to another LVAD implantation/explantation 5. Pregnant or breast-feeding women. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Deutsches Herzzentrum Berlin | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| German Heart Institute | Baxter Healthcare Corporation |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |
| Secondary | 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. | At the moment of VAD-Removal/Transplantation | No |
| Secondary | Clinical outcome | Surgery times (duration) during explantation/transplantation Dissection time (START: skin incision; STOP: on-pump time) Dissection time by region dissected, calculated as time to go to bypass (START: skin incision; STOP: initiation of bypass) by number of the investigational regions with adhesions dissected in this interval Time to VAD removal (START: skin incision; STOP: time of VAD removal from patient's chest at 2nd study operation) Length of operation (START: skin incision; STOP: chest closure). |
At the moment of VAD removal/transplantation (>6 weeks after VAD implantation) | No |
| Secondary | Adhesion related | Percentage of patients with grade 3 adhesions at VAD grafts Mean incidence score Mean adhesion severity score Percentage of sites free of adhesions Time required for adhesion dissection - pure dissection time before and after the CPB |
At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation) | No |