COVADIS Pilot Trial: COseal in Ventricular Assist DevIceS (COVADIS)

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Roland Hetzer, MD, PhD; Phone Number: ++49/30/4593 2000; Email: hetzer@dhzb.de
• Study Contact Backup: Name: Thomas Krabatsch, MD, PhD; Phone Number: ++49/30/4593 2000; Email: krabatsch@dhzb.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Deutsches Herzzentrum Berlin
    • Principal Investigator: Roland Hetzer, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with end stage heart failure, awaiting heart transplantion, with need for VAD (ventricular assist device)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	At the moment of VAD-Removal/Transplantation
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)
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)

Collaborators and Investigators

• Sponsor: German Heart Institute
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Roland Hetzer, MD, PhD, Deutsches Herzzentrum Berlin, Germany

Publications and helpful links

Helpful Links

• Homepage of Deutsches Herzzentrum Berlin

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: November 18, 2010
• First Submitted That Met QC Criteria: November 18, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Estimate): January 29, 2015
• Last Update Submitted That Met QC Criteria: January 28, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: heart transplantation; Ventricular assist device; End stage heart failure; Patients with end stage heart failure; awaiting heart transplantation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: COVADIS002