drugset / Trial / NCT06966687
Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI)
Enrolling by invitation
200 enrolled
Nanjing Medical University
Beijing Anzhen Hospital · collabShanghai East Hospital of Tongji University · collabThe First Affiliated Hospital of Guangzhou Medical University · collabWest China Hospital · collab
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2025-04-01
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thymalfasin | Peptide | 1.6 mg | — |
| Comparator | Ulinastatin | Protein / enzyme biologic | 100000 iu | — |