MIECC vs Conventional Cardiopulmonary Bypass and Systemic Inflammation in CABG (MIECC-CABG)
15. september 2026 oppdatert av: Umran Karaca, Bursa Yuksek Ihtisas Training and Research Hospital
Comparison of the Effects of Minimally Invasive and Conventional Extracorporeal Circulation on Systemic Inflammation Indices in Coronary Artery Bypass Surgery
This prospective observational study evaluates the effects of minimally invasive extracorporeal circulation (MIECC) and conventional cardiopulmonary bypass on systemic inflammatory response in patients undergoing coronary artery bypass graft surgery.
Adult patients undergoing elective coronary artery bypass surgery will be observed according to the extracorporeal circulation technique used during surgery.
Systemic inflammation will be assessed using routinely available hematologic inflammatory indices, including the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII).
These parameters will be evaluated preoperatively, at postoperative 6 hours, at postoperative 24 hours, and at hospital discharge.
The study will also evaluate selected perioperative and postoperative clinical outcomes in order to compare the inflammatory response associated with MIECC and conventional extracorporeal circulation.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
Coronary artery bypass graft surgery performed with cardiopulmonary bypass is associated with activation of systemic inflammatory pathways. Contact of blood with the extracorporeal circuit, surgical trauma, ischemia-reperfusion injury, and perioperative factors may contribute to this response. Minimally invasive extracorporeal circulation systems are designed to reduce blood-air contact, circuit surface area, and hemodilution and may therefore attenuate the inflammatory response compared with conventional cardiopulmonary bypass.
In this prospective observational study, patients undergoing elective coronary artery bypass graft surgery will be evaluated according to whether minimally invasive extracorporeal circulation or conventional extracorporeal circulation is used during surgery. No treatment assignment will be made by the study protocol.
Inflammatory response will be assessed using neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and systemic immune-inflammation index calculated from routinely obtained laboratory measurements. Measurements will be evaluated preoperatively, at 6 hours after surgery, at 24 hours after surgery, and at hospital discharge. Perioperative variables and postoperative clinical outcomes will also be recorded for comparison between the two groups.
Studietype
Observasjonsmessig
Registrering (Antatt)
80
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ümran Karaca, M.D.
- Telefonnummer: +90 505 494 16 87
- E-post: umransuna@gmail.com
Studiesteder
-
-
Bursa
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Bursa, Bursa, Tyrkia (Türkiye), 16000
- Rekruttering
- Bursa Yuksek Ihtisas Training and Research Hospital
-
Ta kontakt med:
- Ümran Karaca, M.D.
- Telefonnummer: +90 505 494 16 87
- E-post: umransuna@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adult patients aged 30-70 years undergoing elective coronary artery bypass graft surgery with either minimally invasive extracorporeal circulation or conventional cardiopulmonary bypass at Bursa Yuksek Ihtisas Training and Research Hospital.
Beskrivelse
Inclusion Criteria:
- Age 30-70 years
- Patients undergoing elective coronary artery bypass graft surgery
- Patients in whom cardiopulmonary bypass is planned
- Written informed consent obtained
Exclusion Criteria:
- Emergency surgery
- Redo cardiac surgery
- Concomitant valve surgery
- Previous open heart surgery
- Preoperative renal and/or hepatic failure
- Malignancy
- Active infection or inflammatory disease-
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
MIECC Group
Patients undergoing coronary artery bypass graft surgery using minimally invasive extracorporeal circulation (MIECC) as part of routine clinical care.
|
Use of a minimally invasive extracorporeal circulation system during coronary artery bypass graft surgery as part of routine clinical care.
|
|
Conventional Cardiopulmonary Bypass Group
Patients undergoing coronary artery bypass graft surgery using conventional cardiopulmonary bypass as part of routine clinical care.
|
Use of conventional cardiopulmonary bypass during coronary artery bypass graft surgery as part of routine clinical care.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Neutrophil-to-Lymphocyte Ratio (NLR)
Tidsramme: Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
|
NLR will be calculated from routine complete blood count values by dividing the absolute neutrophil count by the absolute lymphocyte count.
Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
|
Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
|
|
Platelet-to-Lymphocyte Ratio (PLR)
Tidsramme: Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
|
PLR will be calculated from routine complete blood count values by dividing the platelet count by the absolute lymphocyte count.
Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
|
Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
|
|
Systemic Immune-Inflammation Index (SII)
Tidsramme: Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
|
SII will be calculated as neutrophil count × platelet count / lymphocyte count using routine complete blood count values.
Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
|
Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. februar 2026
Primær fullføring (Antatt)
31. desember 2026
Studiet fullført (Antatt)
31. januar 2027
Datoer for studieregistrering
Først innsendt
10. september 2026
Først innsendt som oppfylte QC-kriteriene
15. september 2026
Først lagt ut (Faktiske)
16. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2024-TBEK 2026/01-10
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared because data sharing was not included in the approved study protocol or informed consent process.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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