Cardiac DiseaseNCT06770738
EuroSCORE-II and POSPOM in Cardiac Surgery
An observational study of Cardiac Disease and Cardiovascular Diseases, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
We aim to compare the performances of the European System for Cardiac Operative Risk Evaluation (EuroSCORE-II) and the PreOperative Score to Predict Postoperative Mortality (POSPOM) in predicting in-hospital mortality among patients undergoing on-pump cardiac surgery, with further evaluation of discrimination… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiac Disease, Cardiovascular Diseases, Cardiovascular Complication
- How many people
- 320 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2025to 18 Nov 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In Turkish people including all genders at the age of 18-99 and was operated open heart surgery will be the study population.
Who may be able to join
- Patients aged 18 and over, patients who have CABG surgery, valve surgery or both, and patients with on-pump surgery will be included in the study.
Who cannot join
- . Patients under the age of 18, patients with off-pump surgery, and patients with non-cardiac vascular surgery will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Performance of EuroSCORE-II and POSPOM for Perioperative Mortality in Cardiac Surgery: A Retrospective Study
We aim to compare the performances of the European System for Cardiac Operative Risk Evaluation (EuroSCORE-II) and the PreOperative Score to Predict Postoperative Mortality (POSPOM) in predicting in-hospital mortality among patients undergoing on-pump cardiac surgery, with further evaluation of discrimination, calibration, agreement, and clinical utility.
This retrospective observational study will be conducted at a single tertiary university cardiac surgery centre. Adult patients (≥18 years) who underwent coronary artery bypass grafting, valve surgery, or combined procedures between 2020 and 2024 will be included. No experimental interventions will be applied. Preoperative EuroSCORE-II and POSPOM values will be calculated for all patients. Discrimination will be assessed using ROC and precision-recall curves with DeLong's test. Calibration will be evaluated using calibration-in-the-large, calibration slope, Hosmer-Lemeshow testing, and GiViTI calibration belts. Agreement will be analyzed using ICC, CCC, Bland-Altman plots, and Passing-Bablok and Deming regression. Subgroup analyses will be performed by age and sex.
Read the detailed description
Preoperative risk assessment is important in determining the treatment plans of patients who will undergo surgery, providing patient education for the postoperative period, providing insight into prognosis, and determining healthcare quality standards. The European System for Cardiac Operative Risk Evaluation-II (EuroSCORE-II) was developed specifically for patients in cardiac surgery. It is a scoring system widely used worldwide that predicts mortality through preoperative evaluation. New studies in the literature have reported that the sensitivity of EuroSCORE-II may be lower in older patients (over 70 and 80 years of age). A scoring system with higher predictive power is aimed by making modifications to EuroSCORE-II or by making comparisons with other scoring systems. PreOperative Score to Predict Post-Operative Mortality (POSPOM), defined by Le Manach et al. in 2016, is a useful scoring system that can be used for all types of surgery and can predict postoperative mortality through preoperative evaluation of patients. POSPOM includes parameters that evaluate the patient's age, the type of surgery to be performed, and the patient's comorbidities. It appears to be a useful scoring system because it is applicable to all types of surgery and provides information about patient mortality in a short time by collecting patient values in 3 main groups. There are various studies conducted on patients undergoing hip fractures, radical cystectomy, uro-oncological surgery, and non-cardiac vascular surgery. However, a review of the literature revealed an absence of studies investigating cardiac surgery patients alone.
The primary objective of this study was to investigate whether the POSPOM score has sufficient predictive power for in-hospital mortality in patients undergoing cardiac surgery. The secondary objective was to evaluate the correlation between POSPOM mortality predictions and EuroSCORE-II mortality predictions in patients undergoing cardiac surgery.
- Conditions
- Cardiac Disease, Cardiovascular Diseases, Cardiovascular Complication, Anesthesia, Perioperative/Postoperative Complications, Surgery
- Being tested
- There is no intervention in this study.
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention in this study.Other
This study is planned as a retrospective study. Only the information of the patients will be used.
| Study group | Role | What they receive |
|---|---|---|
| Operation group | Patients aged 18 and over, patients who have CABG surgery, valve surgery or both, and patients with on-pump surgery in 2020-2024 will be included in the study. The sample size was calculated as 314 with an effect size of 0.2, 95% power and 0.05 error level using the G Power 3.1.9.2 package program, taking into account the study of Kaplan et al. Receives: Other: There is no intervention in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
investigation whether the POSPOM score has sufficient predictive power for in-hospital mortality in patients undergoing cardiac surgery
The primary objective of this study was to investigate whether the POSPOM score has sufficient predictive power for in-hospital mortality in patients undergoing cardiac surgery.
Measure Type: Continuous Unit of Measure: ROC-AUC
Minimum: 0.50 Maximum: 1.00
Description of Meaningful Outcome:
Predictive performance will be considered clinically meaningful if the ROC-AUC of the POSPOM score for in-hospital mortality is significantly greater than 0.50.
Measured: 1 month
Secondary outcomes (1)
Correlation of EuroSCORE-II and POSPOM
Evaluation of the correlation between POSPOM mortality predictions and EuroSCORE-II mortality predictions in patients undergoing cardiac surgery.
Measure Type: Continuous Unit of Measure: Correlation coefficient (r)
Minimum: -1.0 Maximum: +1.0
Description of Meaningful Outcome:
A statistically significant correlation coefficient (p < 0.05) will indicate agreement between POSPOM and EuroSCORE-II mortality predictions. A correlation coefficient of |r| ≥ 0.50 will be considered clinically meaningful.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start3 Jan 2025
- Primary completion15 Oct 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerem Erkalp, MD, Prof, Istanbul University - Cerrahpasa
- Investigators
- Kerem Erkalp, Dr, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770738
- Sponsor's protocol ID
- 017
- Status last verified
- Dec 2025
- First submitted
- 8 Jan 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Performance of EuroSCORE-II and POSPOM for Perioperative Mortality in Cardiac Surgery: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06770738
- Acronym / sponsor ID
- 017
- Conditions
- Cardiac Disease, Cardiovascular Diseases, Cardiovascular Complication, Anesthesia, Perioperative/Postoperative Complications, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 13 Jan 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.
We aim to compare the performances of the European System for Cardiac Operative Risk Evaluation (EuroSCORE-II) and the PreOperative Score to Predict Postoperative Mortality (POSPOM) in predicting in-hospital mortality among patients undergoing on-pump cardiac surgery, with further evaluation of discrimination, calibration, agreement, and clinical utility.
This retrospective observational study will be conducted at a single tertiary university cardiac surgery centre. Adult patients (≥18 years) who underwent coronary artery bypass grafting, valve surgery, or combined procedures between 2020 and 2024 will be included. No experimental interventions will be applied. Preoperative EuroSCORE-II and POSPOM values will be calculated for all patients. Discrimination will be assessed using ROC and precision-recall curves with DeLong's test. Calibration will be evaluated using calibration-in-the-large, calibration slope, Hosmer-Lemeshow testing, and GiViTI calibration belts. Agreement will be analyzed using ICC, CCC, Bland-Altman plots, and Passing-Bablok and Deming regression. Subgroup analyses will be performed by age and sex.
Detailed description
Preoperative risk assessment is important in determining the treatment plans of patients who will undergo surgery, providing patient education for the postoperative period, providing insight into prognosis, and determining healthcare quality standards. The European System for Cardiac Operative Risk Evaluation-II (EuroSCORE-II) was developed specifically for patients in cardiac surgery. It is a scoring system widely used worldwide that predicts mortality through preoperative evaluation. New studies in the literature have reported that the sensitivity of EuroSCORE-II may be lower in older patients (over 70 and 80 years of age). A scoring system with higher predictive power is aimed by making modifications to EuroSCORE-II or by making comparisons with other scoring systems. PreOperative Score to Predict Post-Operative Mortality (POSPOM), defined by Le Manach et al. in 2016, is a useful scoring system that can be used for all types of surgery and can predict postoperative mortality through preoperative evaluation of patients. POSPOM includes parameters that evaluate the patient's age, the type of surgery to be performed, and the patient's comorbidities. It appears to be a useful scoring system because it is applicable to all types of surgery and provides information about patient mortality in a short time by collecting patient values in 3 main groups. There are various studies conducted on patients undergoing hip fractures, radical cystectomy, uro-oncological surgery, and non-cardiac vascular surgery. However, a review of the literature revealed an absence of studies investigating cardiac surgery patients alone.
The primary objective of this study was to investigate whether the POSPOM score has sufficient predictive power for in-hospital mortality in patients undergoing cardiac surgery. The secondary objective was to evaluate the correlation between POSPOM mortality predictions and EuroSCORE-II mortality predictions in patients undergoing cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operation group | – | Other: There is no intervention in this study.Patients aged 18 and over, patients who have CABG surgery, valve surgery or both, and patients with on-pump surgery in 2020-2024 will be included in the study. The sample size was calculated as 314 with an effect size of 0.2, 95% power and 0.05 error level using the G Power 3.1.9.2 package program, taking into account the study of Kaplan et al. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In Turkish people including all genders at the age of 18-99 and was operated open heart surgery will be the study population.
Key inclusion criteria (1 listed)
- Patients aged 18 and over, patients who have CABG surgery, valve surgery or both, and patients with on-pump surgery will be included in the study.
Key exclusion criteria (1 listed)
- . Patients under the age of 18, patients with off-pump surgery, and patients with non-cardiac vascular surgery will be excluded from the study.
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 |
|---|---|---|
| There is no intervention in this study.This study is planned as a retrospective study. Only the information of the patients will be used. | Other | Operation group |
Primary outcome
investigation whether the POSPOM score has sufficient predictive power for in-hospital mortality in patients undergoing cardiac surgery
Time frame: 1 month
The primary objective of this study was to investigate whether the POSPOM score has sufficient predictive power for in-hospital mortality in patients undergoing cardiac surgery. Measure Type: Continuous Unit of Measure: ROC-AUC Minimum: 0.50 Maximum: 1.00 Description of Meaningful Outcome: Predictive performance will be considered clinically meaningful if the ROC-AUC of the POSPOM score for in-hospital mortality is significantly greater than 0.50.
1 secondary outcome
Correlation of EuroSCORE-II and POSPOM
Time frame: 15 days
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 31 Dec 2025.
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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.
Kerem Erkalp, Dr principal investigator
Professor
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 Cardiac Disease and Cardiovascular Diseases, run by Istanbul University - Cerrahpasa 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 1 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 31 Dec 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?
investigation whether the POSPOM score has sufficient predictive power for in-hospital mortality in patients undergoing cardiac surgery (time frame: 1 month). 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 31 Dec 2025.