Coagulation Changes During Coronary Artery Bypass GraftingNCT07844031
Coagulation Profiles in Conventional and Minimal Invasive Extracorporeal Circulation
An observational study of Coagulation Changes During Coronary Artery Bypass Grafting, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Coagulation Changes During Coronary Artery Bypass Grafting
- What is being tested?
- Conventional extracorporeal circulation and Minimally invasive extracorporeal circulation
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa
About this study
Official title: Comparison of the Effects of Conventional and Minimal Invasive Extracorporeal Circulation Systems on Coagulation Parameters in Open Heart Surgery
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.
Read the detailed description
This prospective observational study compares conventional extracorporeal circulation with minimally invasive extracorporeal circulation (MiECC) in patients aged 30 to 70 years undergoing isolated coronary artery bypass grafting. The circulation method is selected as part of routine clinical care. The protocol plans 40 participants in each group (80 in total). Coagulation parameters, including fibrinogen concentration, platelet count, prothrombin time, activated partial thromboplastin time, and international normalized ratio, are assessed before surgery, immediately after surgery, and 6 and 24 hours after surgery. The primary comparison is the change in fibrinogen concentration from preoperative baseline to 24 hours after surgery between the two groups.
- Being tested
- Conventional extracorporeal circulation, Minimally invasive extracorporeal circulation
- Keywords
- Minimally invasive extracorporeal circulation, Fibrinogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional extracorporeal circulationProcedure or surgery
Conventional extracorporeal circulation used during isolated coronary artery bypass grafting, as selected in routine clinical care.
Minimally invasive extracorporeal circulationProcedure or surgery
Minimally invasive extracorporeal circulation (MiECC) used during isolated coronary artery bypass grafting, as selected in routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Extracorporeal Circulation | Patients undergoing isolated coronary artery bypass grafting with conventional extracorporeal circulation, according to the clinical surgical plan. Receives: 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. Receives: Procedure: Minimally invasive extracorporeal circulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative baseline through 24 hours after surgery
Secondary outcomes (4)
Change in Platelet Count From Preoperative Baseline to 24 Hours After Surgery
Platelet count is measured before surgery, immediately after surgery, and at 6 and 24 hours after surgery. Change from preoperative baseline to 24 hours is compared between the two extracorporeal circulation groups.
Measured: Preoperative baseline through 24 hours after surgery
Change in Prothrombin Time From Preoperative Baseline to 24 Hours After Surgery
Prothrombin time (PT) is measured before surgery, immediately after surgery, and at 6 and 24 hours after surgery. Change from preoperative baseline to 24 hours is compared between the two extracorporeal circulation groups.
Measured: Preoperative baseline through 24 hours after surgery
Change in Activated Partial Thromboplastin Time From Preoperative Baseline to 24 Hours After Surgery
Activated partial thromboplastin time (aPTT) is measured before surgery, immediately after surgery, and at 6 and 24 hours after surgery. Change from preoperative baseline to 24 hours is compared between the two extracorporeal circulation groups.
Measured: Preoperative baseline through 24 hours after surgery
Change in International Normalized Ratio From Preoperative Baseline to 24 Hours After Surgery
International normalized ratio (INR) is measured before surgery, immediately after surgery, and at 6 and 24 hours after surgery. Change from preoperative baseline to 24 hours is compared between the two extracorporeal circulation groups.
Measured: Preoperative baseline through 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation Changes During Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Umran Karaca, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Ümran Karaca, MD, Principal investigator, SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844031
- Sponsor's protocol ID
- BursaYIERH-AR-06
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Conventional and Minimal Invasive Extracorporeal Circulation Systems on Coagulation Parameters in Open Heart Surgery
- ClinicalTrials.gov ID
- NCT07844031
- Acronym / sponsor ID
- BursaYIERH-AR-06
- Keywords
- Minimally invasive extracorporeal circulation, Fibrinogen
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective observational study compares conventional extracorporeal circulation with minimally invasive extracorporeal circulation (MiECC) in patients aged 30 to 70 years undergoing isolated coronary artery bypass grafting. The circulation method is selected as part of routine clinical care. The protocol plans 40 participants in each group (80 in total). Coagulation parameters, including fibrinogen concentration, platelet count, prothrombin time, activated partial thromboplastin time, and international normalized ratio, are assessed before surgery, immediately after surgery, and 6 and 24 hours after surgery. The primary comparison is the change in fibrinogen concentration from preoperative baseline to 24 hours after surgery between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Extracorporeal Circulation | – | Procedure: Conventional extracorporeal circulationPatients undergoing isolated coronary artery bypass grafting with conventional extracorporeal circulation, according to the clinical surgical plan. |
| Minimally Invasive Extracorporeal Circulation | – | Procedure: Minimally invasive extracorporeal circulationPatients undergoing isolated coronary artery bypass grafting with minimally invasive extracorporeal circulation (MiECC), according to the clinical surgical plan. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Emergency surgery.
- Repeat cardiac surgery.
- Valve replacement surgery.
- Postoperative intra-aortic balloon pump use.
- Need for surgical revision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional extracorporeal circulationConventional extracorporeal circulation used during isolated coronary artery bypass grafting, as selected in routine clinical care. | Procedure or surgery | Conventional Extracorporeal Circulation |
| Minimally invasive extracorporeal circulationMinimally invasive extracorporeal circulation (MiECC) used during isolated coronary artery bypass grafting, as selected in routine clinical care. | Procedure or surgery | Minimally Invasive Extracorporeal Circulation |
Primary outcome
Change in Fibrinogen Concentration From Preoperative Baseline to 24 Hours After Surgery
Time frame: Preoperative baseline through 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.
4 secondary outcomes
Change in Platelet Count From Preoperative Baseline to 24 Hours After Surgery
Time frame: Preoperative baseline through 24 hours after surgery
Change in Prothrombin Time From Preoperative Baseline to 24 Hours After Surgery
Time frame: Preoperative baseline through 24 hours after surgery
Change in Activated Partial Thromboplastin Time From Preoperative Baseline to 24 Hours After Surgery
Time frame: Preoperative baseline through 24 hours after surgery
Change in International Normalized Ratio From Preoperative Baseline to 24 Hours After Surgery
Time frame: Preoperative baseline through 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ümran Karaca, MD principal investigator
SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation Changes During Coronary Artery Bypass Grafting, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fibrinogen Concentration From Preoperative Baseline to 24 Hours After Surgery (time frame: Preoperative baseline through 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.