NCT07823400

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Feb 2026Jan 2027

Study Start

First participant enrolled

February 7, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

11 months

First QC Date

September 10, 2026

Last Update Submit

September 15, 2026

Conditions

Keywords

Minimally Invasive Extracorporeal CirculationMIECCCardiopulmonary BypassSystemic InflammationNeutrophil-to-Lymphocyte RatioPlatelet-to-Lymphocyte RatioSystemic Immune-Inflammation IndexCoronary Artery Bypass Grafting

Outcome Measures

Primary Outcomes (3)

  • Neutrophil-to-Lymphocyte Ratio (NLR)

    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)

    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)

    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.

Study Arms (2)

MIECC Group

Patients undergoing coronary artery bypass graft surgery using minimally invasive extracorporeal circulation (MIECC) as part of routine clinical care.

Procedure: Minimally Invasive Extracorporeal Circulation

Conventional Cardiopulmonary Bypass Group

Patients undergoing coronary artery bypass graft surgery using conventional cardiopulmonary bypass as part of routine clinical care.

Procedure: Conventional Cardiopulmonary Bypass

Interventions

Use of a minimally invasive extracorporeal circulation system during coronary artery bypass graft surgery as part of routine clinical care.

MIECC Group

Use of conventional cardiopulmonary bypass during coronary artery bypass graft surgery as part of routine clinical care.

Conventional Cardiopulmonary Bypass Group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Age 30-70 years
  • Patients undergoing elective coronary artery bypass graft surgery
  • Patients in whom cardiopulmonary bypass is planned
  • Written informed consent obtained

You may not qualify if:

  • Emergency surgery
  • Redo cardiac surgery
  • Concomitant valve surgery
  • Previous open heart surgery
  • Preoperative renal and/or hepatic failure
  • Malignancy
  • Active infection or inflammatory disease-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Bursa, 16000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Ümran Karaca, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology and Reanimation

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 16, 2026

Study Start

February 7, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

September 16, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because data sharing was not included in the approved study protocol or informed consent process.

Locations