MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)

Coronary Artery Disease Clinical Trial

— MiECS  

Official title:

Minimally Invasive Extracorporeal Circulation Versus Conventional Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery (MiECS): a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05487612
• Other study ID #: MiECS
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: August 2022
• Source: Aristotle University Of Thessaloniki
• Contact: Georgios Papazisis, Assoc. Prof.
• Phone: +30 2310999323
• Email: papazisg[@]auth.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS). It is designed to ultimately address the emerging effectiveness of MiECC systems in the light of modern perfusion practice worldwide. The primary hypothesis is that MiECC, as compared to conventional CPB (cCPB), reduces the proportion of patients experiencing serious perfusion-related postoperative morbidity after cardiac surgery. The study will be led by the Clinical Research Unit of the Special Unit for Biomedical Research and Education (SUBRE), Aristotle University of Thessaloniki School of Medicine in Greece (AUSoM) with Chief Investigator Professor Kyriakos Anastasiadis, who is a key-opinion-leader in the field of MiECC, founder and Executive Board of MiECTiS.

Description:

Despite a fall in mortality rates over the past decade, patients having cardiac surgery continue to experience serious postoperative complications. The risk of serious and relatively common surgical complications is often a consequence of stopping the heart during the operation, using the heart and lung machine (conventional cardiopulmonary bypass; cCPB), and restarting and reperfusing the heart at the end of the operation. Although several strategies have been developed to reduce such complications, they still occur and can be life threatening; they also increase the length of time a patient spends in the hospital.

Miniaturised heart lung machines (minimally invasive extracorporeal circulation; MiECC) have been developed with the aim of reducing the number of postoperative complications arising from using cCPB. Because of the variety of miniaturised systems that have been evaluated, the different types of patients and outcomes investigated, and the poor quality of previous studies, the effectiveness of MiECC in reducing postoperative complications has not been established and most hospitals continue to use cCPB.

Our primary hypothesis is that, compared to cCPB, using a MiECC system during cardiac surgery reduces the proportion of patients having one of several serious postoperative complications (death, myocardial infarction, stroke, acute kidney injury, reintubation, tracheostomy, mechanical ventilation for more than 48 hours, or reoperation) up to 30 days after surgery. In addition, the investigators hypothesise that MiECC reduces the amount of blood products transfused, time to discharge from the cardiac intensive care unit and hospital and the health care resources used during the hospital stay.

Study investigators propose to carry out a large, multicentre randomised controlled trial in 10 to 15 cardiac surgery centres worldwide. Patients will be eligible if they are having coronary artery bypass surgery, aortic valve replace or both using a heart lung machine without circulatory arrest. Centres may recruit patients having all, or a subset of, operation types.

It is expected that 20 % to 23% of patients will experience one or more of the serious complications (the primary outcome). In order to be able confidently to detect a 30% relative reduction in the risk of this outcome, the investigators plan to recruit 1,300 participants across all sites.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• All patients undergoing any elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or CABG+AVR surgery using extracorporeal circulation without circulatory arrest.

Exclusion Criteria:

• Requirement for emergency or salvage operation.

• Requirement for major aortic surgery (e.g. aortic root replacement).

• Contraindication or objection (e.g. Jehovah's Witnesses) to transfusion of blood products.

• Congenital or acquired platelet, red cell or clotting disorders (patients with iron deficient anaemia will not be excluded).

• Inability to give informed consent for the study (e.g. learning or language difficulties).

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Coronary Artery Disease
• Extracorporeal Circulation; Complications

Intervention

Device:
• Minimal Invasive Extracorporeal Circulation
Cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC).
• Conventional cardiopulmonary bypass
Cardiac surgery with conventional cardiopulmonary bypass (cCPB).

Locations

Country	Name	City	State
Canada	Perfusion Services University Health Network, Toronto General Hospital	Toronto
Germany	Department of Cardiothoracic and Vascular Surgery	Braunschweig
Germany	Department of Cardiac Surgery	Coswig
Germany	Department of Thoracic and Cardiovascular Surgery, University Medical Centre Goettingen	Göttingen
Germany	Department of Cardiothoracic and Vascular Surgery, Ulm University Hospital	Ulm
Greece	Cardiothoracic Department AHEPA University Hospital	Thessaloníki
Italy	Department of Cardiac Surgery GVM Anthea Hospital	Bari
Italy	Department of Cardiac Surgery GVM Maria Eleonora Hospital	Palermo
Switzerland	Department of Cardiovascular Surgery, University Hospital Bern	Bern
Turkey	Department of Cardiovascular Surgery, Ankara City Hospital	Ankara
United Kingdom	Department of Cardiac Surgery, Royal Papworth Hospital	Cambridge
United Kingdom	Deparment of Cardiac Surgery, Castle Hill Hospital	Hull
United Kingdom	Department of Cardiothoracic Surgery, Hammersmith Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Clinical Research Unit, School of Medicine, Aristotle University of Thessaloniki

Countries where clinical trial is conducted

Canada,  Germany,  Greece,  Italy,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (7)

Anastasiadis K, Antonitsis P, Asteriou C, Deliopoulos A, Argiriadou H. Modular minimally invasive extracorporeal circulation ensures perfusion safety and technical feasibility in cardiac surgery; a systematic review of the literature. Perfusion. 2021 Jun 17:2676591211026514. doi: 10.1177/02676591211026514. [Epub ahead of print] — View Citation

Anastasiadis K, Argiriadou H, Deliopoulos A, Antonitsis P. Minimal invasive extracorporeal circulation (MiECC): the state-of-the-art in perfusion. J Thorac Dis. 2019 Jun;11(Suppl 10):S1507-S1514. doi: 10.21037/jtd.2019.01.66. — View Citation

Anastasiadis K, Murkin J, Antonitsis P, Bauer A, Ranucci M, Gygax E, Schaarschmidt J, Fromes Y, Philipp A, Eberle B, Punjabi P, Argiriadou H, Kadner A, Jenni H, Albrecht G, van Boven W, Liebold A, de Somer F, Hausmann H, Deliopoulos A, El-Essawi A, Mazzei V, Biancari F, Fernandez A, Weerwind P, Puehler T, Serrick C, Waanders F, Gunaydin S, Ohri S, Gummert J, Angelini G, Falk V, Carrel T. Use of minimal invasive extracorporeal circulation in cardiac surgery: principles, definitions and potential benefits. A position paper from the Minimal invasive Extra-Corporeal Technologies international Society (MiECTiS). Interact Cardiovasc Thorac Surg. 2016 May;22(5):647-62. doi: 10.1093/icvts/ivv380. Epub 2016 Jan 26. Review. — View Citation

COMICS investigators, The COMICS investigators. Conventional versus minimally invasive extracorporeal circulation in patients undergoing cardiac surgery: protocol for a randomised controlled trial (COMICS). Perfusion. 2021 May;36(4):388-394. doi: 10.1177/0267659120946731. Epub 2020 Aug 12. — View Citation

Kowalewski M, Pawliszak W, Raffa GM, Malvindi PG, Kowalkowska ME, Zaborowska K, Kowalewski J, Tarelli G, Taggart DP, Anisimowicz L. Safety and efficacy of miniaturized extracorporeal circulation when compared with off-pump and conventional coronary artery bypass grafting: evidence synthesis from a comprehensive Bayesian-framework network meta-analysis of 134 randomized controlled trials involving 22 778 patients. Eur J Cardiothorac Surg. 2016 May;49(5):1428-40. doi: 10.1093/ejcts/ezv387. Epub 2015 Nov 3. — View Citation

Ranucci M, Johnson I, Willcox T, Baker RA, Boer C, Baumann A, Justison GA, de Somer F, Exton P, Agarwal S, Parke R, Newland RF, Haumann RG, Buchwald D, Weitzel N, Venkateswaran R, Ambrogi F, Pistuddi V. Goal-directed perfusion to reduce acute kidney injury: A randomized trial. J Thorac Cardiovasc Surg. 2018 Nov;156(5):1918-1927.e2. doi: 10.1016/j.jtcvs.2018.04.045. Epub 2018 Apr 18. — View Citation

Wahba A, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Kunst G, Puis L; EACTS/EACTA/EBCP Committee Reviewers. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardiothorac Surg. 2020 Feb 1;57(2):210-251. doi: 10.1093/ejcts/ezz267. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome of postoperative serious adverse events	Incidence of: death, postoperative myocardial infarction according to Fourth Universal Definition of myocardial infarction, stroke, all stage acute kidney injury, as defined with AKI Network criteria, Re-intubation, need for mechanical ventilation for > 48 hours, including multiple episodes when separated by more than 12 hours, reoperation and septicaemia confirmed by positive blood culture.	30 days after randomization following the index admission
Secondary	All-cause mortality	All-cause mortality	30 days after randomization following the index admission
Secondary	New-onset postoperative atrial fibrillation	Incidence of new-onset postoperative atrial fibrillation	Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.
Secondary	Rate of red blood cells transfusion	Units of red blood cells transfused	30 days after randomization following the index admission
Secondary	Rate of platelet transfusion	Units of platelets transfused	30 days after randomization following the index admission
Secondary	Rate of fresh frozen plasma transfusion	Units of fresh frozen plasma transfused	30 days after randomization following the index admission
Secondary	Rate of cryoprecipitate transfusion	Units of cryoprecipitate transfused	30 days after randomization following the index admission
Secondary	Activated Factor VII administration	Incidence of activated factor VII administration	30 days after randomization following the index admission
Secondary	Fibrinogen administration	Incidence of fibrinogen administration	30 days after randomization following the index admission
Secondary	Prothrombin complex concentrate administration	Incidence of prothrombin complex concentrate administration	30 days after randomization following the index admission
Secondary	Time to discharge from cardiac ICU	Time to discharge from cardiac ICU	Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.
Secondary	Time to discharge from hospital	Time to discharge from hospital	Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.
Secondary	Delirium	Incidence of postoperative delirium	Up to 5 days postoperatively
Secondary	Health-Related Quality of Life (HRQoL)	HRQoL assessed with EQ-5D questionnaire	90 days after randomization

External Links

•   MiECS Clinical Trial Registry by Dendrite