NCT07583290Active, not recruiting
Artificial Intelligence for Ulinastatin Responder Outcome & Risk Assessment in CPB
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
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 20 Mar 2026
- Start date
- 1 Jan 2018
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Beijing Anzhen Hospital
- NCT number
- NCT07583290
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 1 Jan 2018 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who had undergone cardiopulmonary bypass surgery multiple times;
Age
- Patients with incomplete clinical records, lacking key information such as patient ID, age, gender and disease diagnosis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Cardiac Surgery and Critical Care Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.