Recruiting
NA
INTERVENTIONAL
NCT05339529
Protective Effect of Thymosin Α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)
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 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 during the acute phase of AAS will result in a reduced incidence of SIRS and MODS.
Interventions
Name:
Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-
Type:
DRUG
Description:
Thymosin alpha 1, 1.6mg injection hypodermic (I.H), every 12 hours for 5 days at least during the ICU admission. The administration will be terminated any day during the treatment when the patient is deemed as qualified for ICU discharge or dead.
Name:
Blank control
Type:
DRUG
Description:
Blank control
Primary Outcomes
Measure:
The highest Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery
TimeFrame:
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
NCT05339529
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Nanjing Medical University
Last Updated
December 15, 2025