Enrolling By Invitation
NA
INTERVENTIONAL
NCT06966687
Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Ulinastatin and Thymosin α1
Type:
DRUG
Description:
Ulinastatin (100000U TID for 5 days) and Thymosin alpha 1 (1.6 mg q12h for 5 days) immediately after surgery
Name:
Ulinastatin only
Type:
DRUG
Description:
Ulinastatin (100000U TID for 5 days) immediately after surgery
Primary Outcomes
Measure:
The mean Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery
TimeFrame:
within the prior 7 days after surgery.
Description:
The occurrence of new-onset organ failure and new-onset persistent organ failure (Sequential Organ Failure Assessment (SOFA) score. New-onset is defined as events that occur after randomization and not present 24 hours before randomization.
Trial Information
NCT ID
NCT06966687
Status
Enrolling By Invitation
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Nanjing Medical University
Last Updated
December 15, 2025