COVADIS Pilot Trial: COseal in Ventricular Assist DevIceS

• Conditions: End-stage Heart Failure Awaiting VAD Implantation

• Registration Number: NCT01244321
• Lead Sponsor: German Heart Institute

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.

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 Timeline

• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Study Start: 2010-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-29
• Primary Completion: 2017-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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; 1. Dissection time (START: skin incision; STOP: on-pump time); 2. 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; 3. Time to VAD removal (START: skin incision; STOP: time of VAD removal from patient's chest at 2nd study operation); 4. Length of operation (START: skin incision; STOP: chest closure).
Adhesion related	At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation)	1. Percentage of patients with grade 3 adhesions at VAD grafts; 2. Mean incidence score; 3. Mean adhesion severity score; 4. Percentage of sites free of adhesions; 5. Time required for adhesion dissection - pure dissection time before and after the CPB

Trial Locations

Locations (1)

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany