COVADIS Pilot Trial: COseal in Ventricular Assist DevIceS

Sponsor

German Heart Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT01244321

Collaborator

Baxter Healthcare Corporation (Industry)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
End-stage Heart Failure Awaiting VAD Implantation

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official 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)

Study Start Date :

Dec 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Presence and severity of adhesions [At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation)]
Assessment of adhesions using a scoring system, assessing six different sites.

Secondary Outcome Measures

Bleeding [At the moment of VAD-Removal/Transplantation]
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.
Clinical outcome [At the moment of VAD removal/transplantation (>6 weeks after VAD implantation)]
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).
Adhesion related [At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria (CoSeal group):

Written informed consent obtained from the subject prior to participation in the study
At least 18 years of age
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):

Written informed consent obtained from the subject prior to participation in the study
At least 18 years of age
Subjects who had a LVAD for more than 6 weeks.

Exclusion criteria (CoSeal group):

Concomitant use of any other anti-adhesion product
Immune system disorders, immuno-deficiencies or immuno-suppression
Known hypersensitivity to components of the study product
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
Patients who were previously subject to another LVAD implantation/explantation
Pregnant or breast-feeding women.

Exclusion criteria (Co Seal control group):

Known use of any other anti-adhesion product during VAD implantation
Immune system disorders, immuno-deficiencies or immuno-suppression
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
Patients who were previously subject to another LVAD implantation/explantation
Pregnant or breast-feeding women.