Clinical Evaluation of a Modular Extracorporeal Circulation Circuit

NCT ID: NCT02000544

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 403 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2020-12-31

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.

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.

Conditions

Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease; Aortic Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modular Cardiopulmonary Bypass Circuit

Patients undergoing open heart surgery with a modular hybrid extracorporeal circulation circuit.

Group Type: OTHER

Modular Cardiopulmonary Bypass Circuit

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Beating heart surgery
• Age more than 80 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHEPA University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyriakos Anastasiadis

Professor Kyriakos Anastasiadis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyriakos Anastasiadis, MD, DSc, FETCS

Role: STUDY_DIRECTOR

AHEPA University Hospital

Locations

AHEPA University Hospital

Thessaloniki, , Greece

Countries

Greece

References

Anastasiadis K, Fragoulakis V, Antonitsis P, Maniadakis N. Coronary artery bypass grafting with minimal versus conventional extracorporeal circulation; an economic analysis. Int J Cardiol. 2013 Oct 15;168(6):5336-43. doi: 10.1016/j.ijcard.2013.08.006. Epub 2013 Aug 15.

Reference Type: BACKGROUND

PMID: 23992927 (View on PubMed)

Anastasiadis K, Asteriou C, Antonitsis P, Argiriadou H, Grosomanidis V, Kyparissa M, Deliopoulos A, Konstantinou D, Tossios P. Enhanced recovery after elective coronary revascularization surgery with minimal versus conventional extracorporeal circulation: a prospective randomized study. J Cardiothorac Vasc Anesth. 2013 Oct;27(5):859-64. doi: 10.1053/j.jvca.2013.01.010. Epub 2013 Jun 18.

Reference Type: BACKGROUND

PMID: 23791499 (View on PubMed)

Asteriou C, Antonitsis P, Argiriadou H, Deliopoulos A, Konstantinou D, Foroulis C, Papakonstantinou C, Anastasiadis K. Minimal extracorporeal circulation reduces the incidence of postoperative major adverse events after elective coronary artery bypass grafting in high-risk patients. A single-institutional prospective randomized study. Perfusion. 2013 Jul;28(4):350-6. doi: 10.1177/0267659113479135. Epub 2013 Mar 21.

Reference Type: BACKGROUND

PMID: 23520169 (View on PubMed)

Anastasiadis K, Antonitsis P, Haidich AB, Argiriadou H, Deliopoulos A, Papakonstantinou C. Use of minimal extracorporeal circulation improves outcome after heart surgery; a systematic review and meta-analysis of randomized controlled trials. Int J Cardiol. 2013 Apr 5;164(2):158-69. doi: 10.1016/j.ijcard.2012.01.020. Epub 2012 Feb 8.

Reference Type: BACKGROUND

PMID: 22325958 (View on PubMed)

Anastasiadis K, Antonitsis P, Argiriadou H, Khayat A, Papakonstantinou C, Westaby S. Use of minimal extracorporeal circulation circuit for left ventricular assist device implantation. ASAIO J. 2011 Nov-Dec;57(6):547-9. doi: 10.1097/MAT.0b013e318232d5d5.

Reference Type: BACKGROUND

PMID: 21970982 (View on PubMed)

Anastasiadis K, Chalvatzoulis O, Antonitsis P, Deliopoulos A, Argiriadou H, Karapanagiotidis G, Kambouroglou D, Papakonstantinou C. Use of minimized extracorporeal circulation system in noncoronary and valve cardiac surgical procedures-a case series. Artif Organs. 2011 Oct;35(10):960-3. doi: 10.1111/j.1525-1594.2010.01183.x. Epub 2011 Apr 19.

Reference Type: BACKGROUND

PMID: 21501191 (View on PubMed)

Anastasiadis K, Argiriadou H, Kosmidis MH, Megari K, Antonitsis P, Thomaidou E, Aretouli E, Papakonstantinou C. Neurocognitive outcome after coronary artery bypass surgery using minimal versus conventional extracorporeal circulation: a randomised controlled pilot study. Heart. 2011 Jul;97(13):1082-8. doi: 10.1136/hrt.2010.218610. Epub 2011 Feb 28.

Reference Type: BACKGROUND

PMID: 21357641 (View on PubMed)

Anastasiadis K, Westaby S, Antonitsis P, Argiriadou H, Karapanagiotidis G, Pigott D, Papakonstantinou C. Minimal extracorporeal circulation circuit standby for "off-pump" left ventricular assist device implantation. Artif Organs. 2010 Dec;34(12):1156-8. doi: 10.1111/j.1525-1594.2009.00983.x.

Reference Type: BACKGROUND

PMID: 20545669 (View on PubMed)

Anastasiadis K, Asteriou C, Deliopoulos A, Argiriadou H, Karapanagiotidis G, Antonitsis P, Grosomanidis V, Misias G, Papakonstantinou C. Haematological effects of minimized compared to conventional extracorporeal circulation after coronary revascularization procedures. Perfusion. 2010 Jul;25(4):197-203. doi: 10.1177/0267659110373840. Epub 2010 Jun 1.

Reference Type: BACKGROUND

PMID: 20515982 (View on PubMed)

Other Identifiers

MiECC MODULAR

Identifier Type: -

Identifier Source: org_study_id