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Clinical Evaluation of a Modular Extracorporeal Circulation Circuit (MiECC MODULAR)

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ClinicalTrials.gov Identifier: NCT02000544
Recruitment Status : Recruiting
First Posted : December 4, 2013
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Kyriakos Anastasiadis, AHEPA University Hospital

Brief Summary:
The purpose of this clinical research study is the design of a novel modular hybrid system extracorporeal circulation circuit for open heart procedures that could easily be converted from a closed to a semi-closed circuit according to the indication. This could expand the potential of minimal extracorporeal circulation and could ultimately become the new standard circuit in performing every type of cardiac surgery.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Aortic Valve Disease Mitral Valve Disease Aortic Aneurysm Device: Modular Cardiopulmonary Bypass Circuit Not Applicable

Detailed Description:

Development of cardiopulmonary bypass circuit (heart-lung machine) is considered as a landmark breakthrough in cardiac surgery, greatly promoting treatment of cardiovascular diseases. Since 1953, when the first operation under cardiopulmonary bypass was performed and for almost 6 decades, little progress has been made in the direction of improving cardiopulmonary bypass technology. However, evolution is feasible. The proposed research project challenges the traditional belief that conventional cardiopulmonary bypass should be considered as "state of the art" technology by deducting solid evidence towards extended use of the novel minimal extracorporeal circulation circuit, which is related to an improved outcome through multiple studies. Research methodology is based on analyzing laboratory and clinical data obtained through implementing the standard and the novel technology. In order to provide solid evidence on the comparative effectiveness of both therapies, it combines analysis of clinical and laboratory data with data related to cost and quality of life. Thus, it assesses novel technology from a global perspective and the evidence obtained would be considered robust.

The ultimate purpose of the research proposal is the design of a modular hybrid system, that could easily convert from form a closed to a semi-closed circuit according to the indication, that could expand the potential of minimal extracorporeal circulation and could ultimately become the new standard circuit in performing every type of cardiac surgery. The term modular refers to an additionally mounted, clamped-off venous reservoir which allows to run the system as an open circuit in case of anticipated volume loss (ie bleeding, complex procedures, long bypass run). This measure follows the proverb 'always expect the unexpected' and offers the clinical practitioner an additional safety margin in case of unexpected intraoperative events. Unique design of this circuit would offer the opportunity of reducing cost, while at the same time improving clinical outcome. Preliminary design of this circuit, performed in our institution, is presented schematically in the appendix. After completion of the study protocol the designed circuit will be patented.

Our institution has already performed extensive research and has gained international reputation as a training centre on minimal extracorporeal circulation. Design of such a circuit could promote further research funded by the medical industry. Considering the number of cardiac surgical procedures performed every day worldwide, this evolution is greatly ambitious and could be characterized as a major breakthrough in the field of cardiac surgery opening up new horizons in the field of cardiovascular research. It would also exert a positive effect on global healthcare affecting lives of millions of people suffering from cardiovascular disease.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation Study of a Novel Modular Extracorporeal Circulation Circuit in Open Heart Surgery
Study Start Date : October 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Modular Cardiopulmonary Bypass Circuit
Patients undergoing open heart surgery with a modular hybrid extracorporeal circulation circuit.
Device: Modular Cardiopulmonary Bypass Circuit
Open heart surgery with a novel hybrid modular extracorporeal circulation circuit which is a closed cardiopulmonary bypass circuit with enhanced safety as it can be instantly converted to an open circuit.




Primary Outcome Measures :
  1. Major adverse cardiac and cerebrovascular events [ Time Frame: One month postoperatively ]
    Cumulative incidence of major adverse cardiac (postoperative myocardial infarction, need for repeat revascularization, prolonged use of inotropes), cerebrovascular (postoperative stroke) events and death during a period of one-month follow-up.


Secondary Outcome Measures :
  1. Total morbidity [ Time Frame: One month ]
    All cause 30-day morbidity

  2. Mortality [ Time Frame: One month ]
    All cause 30-day mortality

  3. Length of hospital stay [ Time Frame: one month ]
    Total length of hospital stay

  4. Length of ICU stay [ Time Frame: one month ]
    Length of Intensive Care Unit stay

  5. Coagulation mechanism [ Time Frame: 24 hours postoperatively ]
    Change in coagulation integrity assessed with rotational thromboelastometry and platelet function assessed with platelet aggregometry.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any heart disease that requires open heart surgery under extracorporeal circulation

Exclusion Criteria:

  • Beating heart surgery
  • Age more than 80 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000544


Contacts
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Contact: Polychronis Antonitsis, MD, DSc + 30 2310994871 antonits@auth.gr

Locations
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Greece
AHEPA University Hospital Recruiting
Thessaloniki, Greece
Contact: Polychronis Antonitsis, MD, DSc    + 30 2310 994871    antonits@auth.gr   
Principal Investigator: Polychronis Antonitsis, MD, DSc         
Sponsors and Collaborators
AHEPA University Hospital
Investigators
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Study Director: Kyriakos Anastasiadis, MD, DSc, FETCS AHEPA University Hospital

Publications:

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Responsible Party: Kyriakos Anastasiadis, Professor Kyriakos Anastasiadis, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT02000544     History of Changes
Other Study ID Numbers: MiECC MODULAR
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

Keywords provided by Kyriakos Anastasiadis, AHEPA University Hospital:
Extracorporeal Circulation
Cardiopulmonary Bypass
Cardiac surgery

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Aneurysm
Aortic Aneurysm
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aortic Diseases