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
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Aortic Valve Disease Mitral Valve Disease Aortic Aneurysm||Device: Modular Cardiopulmonary Bypass Circuit||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Total morbidity [ Time Frame: One month ]All cause 30-day morbidity
- Mortality [ Time Frame: One month ]All cause 30-day mortality
- Length of hospital stay [ Time Frame: one month ]Total length of hospital stay
- Length of ICU stay [ Time Frame: one month ]Length of Intensive Care Unit stay
- Coagulation mechanism [ Time Frame: 24 hours postoperatively ]Change in coagulation integrity assessed with rotational thromboelastometry and platelet function assessed with platelet aggregometry.
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
|Contact: Polychronis Antonitsis, MD, DSc||+ 30 email@example.com|
|AHEPA University Hospital||Recruiting|
|Contact: Polychronis Antonitsis, MD, DSc + 30 2310 994871 firstname.lastname@example.org|
|Principal Investigator: Polychronis Antonitsis, MD, DSc|
|Study Director:||Kyriakos Anastasiadis, MD, DSc, FETCS||AHEPA University Hospital|