NCT07844031

Brief Summary

The aim of this study is to compare the effects of conventional and minimally invasive extracorporeal circulation (MiECC) techniques, which are routinely used in open-heart surgery, on coagulation parameters.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

October 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Completed
Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Coagulation Changes During Coronary Artery Bypass Grafting

Keywords

Minimally invasive extracorporeal circulationFibrinogen

Outcome Measures

Primary Outcomes (1)

  • Change in Fibrinogen Concentration From Preoperative Baseline to 24 Hours After Surgery

    Fibrinogen concentration is measured before surgery, immediately after surgery, and at 6 and 24 hours after surgery. The change from preoperative baseline to 24 hours is compared between the conventional extracorporeal circulation and MiECC groups.

    Preoperative baseline through 24 hours after surgery

Secondary Outcomes (4)

  • Change in Platelet Count From Preoperative Baseline to 24 Hours After Surgery

    Preoperative baseline through 24 hours after surgery

  • Change in Prothrombin Time From Preoperative Baseline to 24 Hours After Surgery

    Preoperative baseline through 24 hours after surgery

  • Change in Activated Partial Thromboplastin Time From Preoperative Baseline to 24 Hours After Surgery

    Preoperative baseline through 24 hours after surgery

  • Change in International Normalized Ratio From Preoperative Baseline to 24 Hours After Surgery

    Preoperative baseline through 24 hours after surgery

Study Arms (2)

Conventional Extracorporeal Circulation

Patients undergoing isolated coronary artery bypass grafting with conventional extracorporeal circulation, according to the clinical surgical plan.

Procedure: Conventional extracorporeal circulation

Minimally Invasive Extracorporeal Circulation

Patients undergoing isolated coronary artery bypass grafting with minimally invasive extracorporeal circulation (MiECC), according to the clinical surgical plan.

Procedure: Minimally invasive extracorporeal circulation

Interventions

Conventional extracorporeal circulationPROCEDURE

Conventional extracorporeal circulation used during isolated coronary artery bypass grafting, as selected in routine clinical care.

Conventional Extracorporeal Circulation
Minimally invasive extracorporeal circulationPROCEDURE

Minimally invasive extracorporeal circulation (MiECC) used during isolated coronary artery bypass grafting, as selected in routine clinical care.

Minimally Invasive Extracorporeal Circulation

Eligibility Criteria

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

Patients aged 30 to 70 years undergoing isolated coronary artery bypass grafting at SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi. The conventional extracorporeal circulation or MiECC method is chosen during routine clinical care, and perioperative coagulation measurements are compared between groups.

You may qualify if:

  • Age 30 to 70 years.
  • Undergoing isolated coronary artery bypass grafting.
  • No known coagulopathy.
  • No diagnosed advanced renal or hepatic failure affecting the coagulation profile.

You may not qualify if:

  • Emergency surgery.
  • Repeat cardiac surgery.
  • Valve replacement surgery.
  • Postoperative intra-aortic balloon pump use.
  • Need for surgical revision.
  • Advanced renal or hepatic failure.
  • Inherited hematologic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, Turkey (Türkiye)

Location

Study Officials

  • Ümran Karaca, MD

    SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 28, 2026

Study Start

October 1, 2025

Primary Completion

October 1, 2026

Study Completion

October 1, 2026

Last Updated

September 28, 2026

Record last verified: 2026-09

Locations

TU(1)