Cardiac Surgical ProceduresAURORANCT07583290
Artificial Intelligence for Ulinastatin Responder Outcome & Risk Assessment in CPB
An observational study of Cardiac Surgical Procedures and Cardiopulmonary Bypass, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
This is a multicenter, retrospective, real-world observational study aimed at developing and validating an artificial intelligence-based tool for identifying ulinastatin treatment responders and risk stratification in cardiac surgery patients undergoing cardiopulmonary bypass (CPB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Systemic Inflammatory Response Syndrome
- What is being tested?
- ulinastatin
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Mar 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent cardiac surgery with cardiopulmonary bypass at 4 tertiary cardiac centers in China, including coronary artery bypass grafting, valve surgery, congenital heart defect repair, and major vascular surgery. Patients are categorized based on perioperative ulinastatin use (ulinastatin group vs. control group). Data collected from electronic medical records.
Who may be able to join
- Patients underwent extracorporeal circulation heart surgery, including coronary artery bypass grafting, valve repair or replacement surgery, congenital heart defect repair surgery, and major vascular and aortic disease surgeries;
- Patients received standard treatment (such as anticoagulation, circulatory support), with or without ulinastatin.
Who cannot join
- Patients who had undergone cardiopulmonary bypass surgery multiple times;
- Patients with incomplete clinical records, lacking key information such as patient ID, age, gender and disease diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of an AI-Based Tool for Identifying Responders and Stratifying Risks in Ulinastatin Treatment in Cardiac Surgery: A Multicenter Real-world Study
This is a multicenter, retrospective, real-world observational study aimed at developing and validating an artificial intelligence-based tool for identifying ulinastatin treatment responders and risk stratification in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).
Ulinastatin, a glycoprotein extracted from human urine, has shown potential benefits in reducing postoperative complications and inflammatory responses in cardiac surgery. However, evidence supporting its efficacy and optimal application in specific patient populations remains insufficient.
This study will collect clinical data from approximately 4 tertiary cardiac centers in China, including patients who underwent cardiac surgery with CPB. Using machine learning algorithms (such as weighted K-modes clustering and XGBoost), the study aims to: (1) construct a multicenter real-world database for cardiac surgery; (2) identify clinical characteristics associated with ulinastatin treatment response; (3) develop and validate an AI-based risk stratification tool to assist clinical decision-making. This study may provide evidence-based guidance for personalized perioperative anti-inflammatory treatment in cardiac surgery.
- Conditions
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Systemic Inflammatory Response Syndrome, Multiple Organ Dysfunction Syndrome, Postoperative Complications
- Being tested
- ulinastatin
- Keywords
- Ulinastatin, Cardiac Surgery, Cardiopulmonary Bypass, Machine Learning, Precision Medicine
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Multiple Organ Failure, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulinastatinDrug
The patient used ulinastatin during the operation and while hospitalized in the ICU, and received mechanical ventilation.
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality occurring during the hospitalization period following cardiac surgery with cardiopulmonary bypass. Mortality is defined as death from any cause that occurs from the time of surgery until hospital discharge, including deaths related to cardiovascular events, multiple organ dysfunction syndrome (MODS), infection, bleeding, or other complications.
Measured: 30 days after the operation
Secondary outcomes (1)
The incidence rate of MODS
The number of new MODS cases occurring in the targeted patients during research time period, divided by the total number of individuals at risk over the same period.
Measured: From the date of hospitalization until the date of hospital discharge or 30 days after the operation, whichever occurs first, assessed up to 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jan 2018
- Primary completion31 Dec 2024
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaotong Hou, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583290
- Sponsor's protocol ID
- 2025-10-AURORA
- Acronym
- AURORA
- Status last verified
- May 2026
- First submitted
- 20 Mar 2026
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an AI-Based Tool for Identifying Responders and Stratifying Risks in Ulinastatin Treatment in Cardiac Surgery: A Multicenter Real-world Study
- ClinicalTrials.gov ID
- NCT07583290
- Acronym / sponsor ID
- AURORA / 2025-10-AURORA
- Conditions
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Systemic Inflammatory Response Syndrome, Multiple Organ Dysfunction Syndrome, Postoperative Complications
- Keywords
- Ulinastatin, Cardiac Surgery, Cardiopulmonary Bypass, Machine Learning, Precision Medicine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 May 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.
This is a multicenter, retrospective, real-world observational study aimed at developing and validating an artificial intelligence-based tool for identifying ulinastatin treatment responders and risk stratification in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).
Ulinastatin, a glycoprotein extracted from human urine, has shown potential benefits in reducing postoperative complications and inflammatory responses in cardiac surgery. However, evidence supporting its efficacy and optimal application in specific patient populations remains insufficient.
This study will collect clinical data from approximately 4 tertiary cardiac centers in China, including patients who underwent cardiac surgery with CPB. Using machine learning algorithms (such as weighted K-modes clustering and XGBoost), the study aims to: (1) construct a multicenter real-world database for cardiac surgery; (2) identify clinical characteristics associated with ulinastatin treatment response; (3) develop and validate an AI-based risk stratification tool to assist clinical decision-making. This study may provide evidence-based guidance for personalized perioperative anti-inflammatory treatment in cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent cardiac surgery with cardiopulmonary bypass at 4 tertiary cardiac centers in China, including coronary artery bypass grafting, valve surgery, congenital heart defect repair, and major vascular surgery. Patients are categorized based on perioperative ulinastatin use (ulinastatin group vs. control group). Data collected from electronic medical records.
Key inclusion criteria (2 listed)
- Patients underwent extracorporeal circulation heart surgery, including coronary artery bypass grafting, valve repair or replacement surgery, congenital heart defect repair surgery, and major vascular and aortic disease surgeries;
- Patients received standard treatment (such as anticoagulation, circulatory support), with or without ulinastatin.
Key exclusion criteria (2 listed)
- Patients who had undergone cardiopulmonary bypass surgery multiple times;
- Patients with incomplete clinical records, lacking key information such as patient ID, age, gender and disease diagnosis.
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 |
|---|---|---|
| ulinastatinThe patient used ulinastatin during the operation and while hospitalized in the ICU, and received mechanical ventilation. | Drug | – |
Primary outcome
All-cause mortality
Time frame: 30 days after the operation
All-cause mortality occurring during the hospitalization period following cardiac surgery with cardiopulmonary bypass. Mortality is defined as death from any cause that occurs from the time of surgery until hospital discharge, including deaths related to cardiovascular events, multiple organ dysfunction syndrome (MODS), infection, bleeding, or other complications.
1 secondary outcome
The incidence rate of MODS
Time frame: From the date of hospitalization until the date of hospital discharge or 30 days after the operation, whichever occurs first, assessed up to 30 days postoperatively.
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 13 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgical Procedures and Cardiopulmonary Bypass, run by Beijing Anzhen Hospital at 1 site in China.
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 2 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 13 May 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 China. 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?
All-cause mortality (time frame: 30 days after the operation). 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 13 May 2026.