ActiveNCT07583290

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

Sponsor: Beijing Anzhen Hospital

Trial Details

Condition	Cardiac Surgical Procedures, Cardiopulmonary Bypass, Systemic Inflammatory Response Syndrome, Multiple Organ Dysfunction Syndrome, Postoperative Complications
Intervention	ulinastatin
Status	Active
Participants	10,000
Est. Completion	31 Dec 2024
Last Updated	13 May 2026

Primary Outcome

All-cause mortality

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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 Sites

Countries

China

View Registry Entry

Related Analysis

Large-Scale Real-World Study Develops AI Tool for Ulinastatin Response Prediction in Cardiac Surgery — 10,000-Patient Chinese Cohort

Chinese researchers are developing an AI tool to predict which cardiac surgery patients will respond to ulinastatin treatment, analyzing data from 10,000 patients across four major cardiac centers. The study aims to enable personalized anti-inflammatory therapy in cardiac surgery.

Read full article →

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