Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

COVADIS Pilot Trial: COseal in Ventricular Assist DevIceS

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by German Heart Institute
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
German Heart Institute
ClinicalTrials.gov Identifier:
NCT01244321
First received: November 18, 2010
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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
End-stage Heart Failure Awaiting VAD Implantation

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by German Heart Institute:

Primary Outcome Measures:
  • Presence and severity of adhesions [ Time Frame: At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation) ] [ Designated as safety issue: No ]
    Assessment of adhesions using a scoring system, assessing six different sites.


Secondary Outcome Measures:
  • Bleeding [ Time Frame: At the moment of VAD-Removal/Transplantation ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the moment of VAD removal/transplantation (>6 weeks after VAD implantation) ] [ Designated as safety issue: No ]

    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 [ Time Frame: At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244321

Contacts
Contact: Roland Hetzer, MD, PhD ++49/30/4593 2000 hetzer@dhzb.de
Contact: Thomas Krabatsch, MD, PhD ++49/30/4593 2000 krabatsch@dhzb.de

Locations
Germany
Deutsches Herzzentrum Berlin Recruiting
Berlin, Germany, 13353
Principal Investigator: Roland Hetzer, MD PhD         
Sponsors and Collaborators
German Heart Institute
Baxter Healthcare Corporation
Investigators
Principal Investigator: Roland Hetzer, MD, PhD Deutsches Herzzentrum Berlin, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Roland Hetzer, MD, PhD, Medical Director and Head of the Clinic for Thoracic and Cardiovascular surgery, German Heart Institute
ClinicalTrials.gov Identifier: NCT01244321     History of Changes
Other Study ID Numbers: COVADIS002
Study First Received: November 18, 2010
Last Updated: January 15, 2013
Health Authority: Germany: Ethic commission

Keywords provided by German Heart Institute:
End stage heart failure
heart transplantation
Ventricular assist device
Patients with end stage heart failure
awaiting heart transplantation

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 23, 2014