CABGNCT06873620
Impact of the Cardiopulmonary Bypass and Cross-Clamp Time Ratio on Postoperative Outcomes in Open Heart Surgery: A Prospective Observational Analysis
An observational study of CABG and Cardiac Anesthesia, run by Ahmet Yuksek at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the relationship between the ratio of cardiopulmonary bypass (CPB) time to cross-clamp (CC) time and postoperative complications in open heart surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CABG, Cardiac Anesthesia, Cardiac Surgery Prognosis
- How many people
- 348 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2024to 15 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be an observational research conducted in our hospital, involving patients aged 18 to 80 who are undergoing on-pump coronary artery bypass grafting (CABG). The study population will consist of individuals within this age range who are scheduled for elective or urgent on-pump CABG surgery.
Who may be able to join
- Patients undergoing open heart surgery
- Undergo on pump surgery
Who cannot join
- Patients undergoing emergency open heart surgery Patients undergoing open heart surgery on a beating heart
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the relationship between the ratio of cardiopulmonary bypass (CPB) time to cross-clamp (CC) time and postoperative complications in open heart surgery. While CPB time and CC duration have been linked to complications, no study has explored the specific ratio between CPB time and CC time in relation to postoperative outcomes. This prospective study seeks to fill that gap.
Read the detailed description
Open heart surgery involves several distinct stages: 1) preparation for cardiopulmonary bypass (CPB), 2) the CPB phase, which includes the cross-clamp (CC) process, and 3) hemostasis and closure. During the CPB phase, the left internal mammary artery (LIMA) and saphenous vein are freed for coronary anastomosis, followed by arterial and venous cannulation. Once cannulation is completed, CPB is initiated. A cross-clamp is placed on the aorta to stop the heart, and cardioplegia solution is administered. Afterward, distal anastomoses are performed, and once completed, the cross-clamp is removed and the heart begins to beat again. The duration the cross-clamp remains in place is referred to as the CC time. In the CPB phase, proximal anastomoses are made on the aorta. After checking for any bleeding, thoracic drains are placed, and the CPB is terminated. Once all controls are in place, the chest is closed, and the patient is transferred to the intensive care unit.
The mortality rate for open heart surgery varies between 1% and 5%, depending on the patient's specific characteristics. Postoperative complications such as bleeding revision, acute kidney injury, liver failure, respiratory failure, and heart failure are common. Literature has linked these complications to vascular conditions, CPB time, and the duration of cross-clamp time. However, no studies were found that specifically compare the ratio of CPB time to CC time with postoperative complications.
In this study, we aim to prospectively investigate the relationship between the ratio of CPB time to cross-clamp time and postoperative complications in patients undergoing open heart surgery.
- Conditions
- CABG, Cardiac Anesthesia, Cardiac Surgery Prognosis, Bypass Complication, On-pump Valve Surgery or CABG, Anesthesia
- Keywords
- on-pump cabg, cardiac anesthesia, cross clamping, cabg complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| on-pomp CABG | All eligible patients undergoing on-pump-assisted CABG surgery will be included in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between CPB/CC time and mortality
CPB/CC time is the ratio of cardiopulmonary bypass (CPB) time to cross-clamp (CC) time in patients undergoing on-pump cardiac surgery.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start23 Feb 2024
- Primary completion1 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CABGStudies 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
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmet Yuksek
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ahmet Yuksek, Kocaeli City Hospital
- Investigators
- Mehmet Yilmaz, Associate Proffessor, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873620
- Sponsor's protocol ID
- KSH-2024-23
- Status last verified
- Nov 2025
- First submitted
- 7 Mar 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD is at the discretion of the institution and written permission must be applied to the institution.
Publications
Yousefshahi F, Samadi E, Paknejad O, Movafegh A, Barkhordari K, Bastan Hagh E, Dehestani B. Prevalence and Risk Factors of Hypoxemia after Coronary Artery Bypass Grafting: The Time to Change Our Conceptions. J Tehran Heart Cent. 2019 Apr;14(2):74-80.
PubMed 31723349Moh'd AF, Al-Odwan HT, Altarabsheh S, Makahleh ZM, Khasawneh MA. Predictors of aortic clamp time duration and intensive care unit length of stay in elective adult cardiac surgery. Egypt Heart J. 2021 Oct 22;73(1):92. doi: 10.1186/s43044-021-00195-0.
PubMed 34677684Parmana IMA, Boom CE, Rachmadi L, Hanafy DA, Widyastuti Y, Mansyur M, Siswanto BB. Correlation Between Cardiac Index, Plasma Troponin I, Myocardial Histopathology, CPB and AoX Duration in Glutamine versus No Glutamine Administered Patients with Low Ejection Fraction Undergoing Elective On-Pump CABG Surgery: Secondary Analysis of an RCT. Vasc Health Risk Manag. 2023 Feb 28;19:93-101. doi: 10.2147/VHRM.S399925. eCollection 2023.
PubMed 36880009Hadipourzadeh F, Rastravan R, Totonchi Z, Heydarpur E, Faritous Z. Evaluating the relationship between lactate levels during coronary artery bypass graft surgery and postoperative renal dysfunction. J Cardiovasc Thorac Res. 2024;16(2):129-134. doi: 10.34172/jcvtr.33051. Epub 2024 Jun 25.
PubMed 39253341
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Cardiopulmonary Bypass and Cross-Clamp Time Ratio on Postoperative Outcomes in Open Heart Surgery: A Prospective Observational Analysis
- ClinicalTrials.gov ID
- NCT06873620
- Acronym / sponsor ID
- KSH-2024-23
- Conditions
- CABG, Cardiac Anesthesia, Cardiac Surgery Prognosis, Bypass Complication, On-pump Valve Surgery or CABG, Anesthesia
- Keywords
- on-pump cabg, cardiac anesthesia, cross clamping, cabg complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Ahmet YuksekOther government
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 12 Mar 2025 (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.
This study aims to investigate the relationship between the ratio of cardiopulmonary bypass (CPB) time to cross-clamp (CC) time and postoperative complications in open heart surgery. While CPB time and CC duration have been linked to complications, no study has explored the specific ratio between CPB time and CC time in relation to postoperative outcomes. This prospective study seeks to fill that gap.
Detailed description
Open heart surgery involves several distinct stages: 1) preparation for cardiopulmonary bypass (CPB), 2) the CPB phase, which includes the cross-clamp (CC) process, and 3) hemostasis and closure. During the CPB phase, the left internal mammary artery (LIMA) and saphenous vein are freed for coronary anastomosis, followed by arterial and venous cannulation. Once cannulation is completed, CPB is initiated. A cross-clamp is placed on the aorta to stop the heart, and cardioplegia solution is administered. Afterward, distal anastomoses are performed, and once completed, the cross-clamp is removed and the heart begins to beat again. The duration the cross-clamp remains in place is referred to as the CC time. In the CPB phase, proximal anastomoses are made on the aorta. After checking for any bleeding, thoracic drains are placed, and the CPB is terminated. Once all controls are in place, the chest is closed, and the patient is transferred to the intensive care unit.
The mortality rate for open heart surgery varies between 1% and 5%, depending on the patient's specific characteristics. Postoperative complications such as bleeding revision, acute kidney injury, liver failure, respiratory failure, and heart failure are common. Literature has linked these complications to vascular conditions, CPB time, and the duration of cross-clamp time. However, no studies were found that specifically compare the ratio of CPB time to CC time with postoperative complications.
In this study, we aim to prospectively investigate the relationship between the ratio of CPB time to cross-clamp time and postoperative complications in patients undergoing open heart surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| on-pomp CABG | – | –All eligible patients undergoing on-pump-assisted CABG surgery will be included in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be an observational research conducted in our hospital, involving patients aged 18 to 80 who are undergoing on-pump coronary artery bypass grafting (CABG). The study population will consist of individuals within this age range who are scheduled for elective or urgent on-pump CABG surgery.
Key inclusion criteria (2 listed)
- Patients undergoing open heart surgery
- Undergo on pump surgery
Key exclusion criteria (1 listed)
- Patients undergoing emergency open heart surgery Patients undergoing open heart surgery on a beating heart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between CPB/CC time and mortality
Time frame: From enrollment to the end of treatment at 8 weeks
CPB/CC time is the ratio of cardiopulmonary bypass (CPB) time to cross-clamp (CC) time in patients undergoing on-pump cardiac surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 31723349Yousefshahi F, Samadi E, Paknejad O, Movafegh A, Barkhordari K, Bastan Hagh E, Dehestani B. Prevalence and Risk Factors of Hypoxemia after Coronary Artery Bypass Grafting: The Time to Change Our Conceptions. J Tehran Heart Cent. 2019 Apr;14(2):74-80.
- Background: PubMed 34677684Moh'd AF, Al-Odwan HT, Altarabsheh S, Makahleh ZM, Khasawneh MA. Predictors of aortic clamp time duration and intensive care unit length of stay in elective adult cardiac surgery. Egypt Heart J. 2021 Oct 22;73(1):92. doi: 10.1186/s43044-021-00195-0.
- Background: PubMed 36880009Parmana IMA, Boom CE, Rachmadi L, Hanafy DA, Widyastuti Y, Mansyur M, Siswanto BB. Correlation Between Cardiac Index, Plasma Troponin I, Myocardial Histopathology, CPB and AoX Duration in Glutamine versus No Glutamine Administered Patients with Low Ejection Fraction Undergoing Elective On-Pump CABG Surgery: Secondary Analysis of an RCT. Vasc Health Risk Manag. 2023 Feb 28;19:93-101. doi: 10.2147/VHRM.S399925. eCollection 2023.
- Background: PubMed 39253341Hadipourzadeh F, Rastravan R, Totonchi Z, Heydarpur E, Faritous Z. Evaluating the relationship between lactate levels during coronary artery bypass graft surgery and postoperative renal dysfunction. J Cardiovasc Thorac Res. 2024;16(2):129-134. doi: 10.34172/jcvtr.33051. Epub 2024 Jun 25.
- Individual participant dataSharing planned: No. Sharing IPD is at the discretion of the institution and written permission must be applied to the institution.
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Coronary Artery Bypass Graft (CABG)
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.
Mehmet Yilmaz, Associate Proffessor principal investigator
Kocaeli City Hospital
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 CABG and Cardiac Anesthesia, run by Ahmet Yuksek 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relationship between CPB/CC time and mortality (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06873620, which also lists 4 linked publications.
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 24 Nov 2025.