MIECC vs Conventional Cardiopulmonary Bypass and Systemic Inflammation in CABG (MIECC-CABG)
15 september 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
80
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ümran Karaca, M.D.
- Telefonnummer: +90 505 494 16 87
- E-post: umransuna@gmail.com
Studieorter
-
-
Bursa
-
Bursa, Bursa, Turkiet (Türkiye), 16000
- Rekrytering
- Bursa Yuksek Ihtisas Training and Research Hospital
-
Kontakt:
- Ümran Karaca, M.D.
- Telefonnummer: +90 505 494 16 87
- E-post: umransuna@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neutrophil-to-Lymphocyte Ratio (NLR)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
7 februari 2026
Primärt slutförande (Beräknad)
31 december 2026
Avslutad studie (Beräknad)
31 januari 2027
Studieregistreringsdatum
Först inskickad
10 september 2026
Först inskickad som uppfyllde QC-kriterierna
15 september 2026
Första postat (Faktisk)
16 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2024-TBEK 2026/01-10
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant data will not be shared because data sharing was not included in the approved study protocol or informed consent process.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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