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ENROLLING BY INVITATION
NCT06966687
NA

Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI)

Sponsor: Nanjing Medical University

View on ClinicalTrials.gov

Summary

Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major causes of death in patients with acute aortic syndrome (AAS). Therefore, the prevention of SIRS and MODS is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 in addition to antiinflammatory treatment may be beneficial. This study was designed to test the hypothesis that the administration of Ulinastatin and Thymosin α1 during the acute phase of AAS will result in a reduced incidence of SIRS and MODS.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-04-01

Completion Date

2026-12-31

Last Updated

2026-01-14

Healthy Volunteers

No

Interventions

DRUG

Ulinastatin and Thymosin α1

Ulinastatin (100000U TID for 5 days) and Thymosin alpha 1 (1.6 mg q12h for 5 days) immediately after surgery

DRUG

Ulinastatin only

Ulinastatin (100000U TID for 5 days) immediately after surgery

Locations (4)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Shanghai East Hospital Tongji University

Shanghai, Shanghai Municipality, China

West China Hospital

Chengdu, Sichuan, China