Clinical trial NCT06966687: Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI)
Official title: Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Aortic Dissection
Aortic Dissection Aneurysm
Keywords: Aortic Dissection
inflammation
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital, Capital Medicine University
name: West China Hospital
name: Shanghai East Hospital,Tongji University School of Medicine
name: The First Affiliated Hospital of Guangzhou Medical University
First posted: 2025-05-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* The patients are conformed to 2010 ACC/AHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset;
* Patients with acute aortic syndrome confirmed clinically and radiologically and planning to undergo emergency surgery were enrolled.
* The patients' age between 18 \~90 years old.
* Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* Patients allergic to Thymosin α1 or Ulinastatin;
* Lactating women and pregnant women;
* Patients with mental diseases, drug and alcohol dependence;
* Refuse to participate in this study and refuse to sign the informed consent.

Primary outcomes:
measure: The mean Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery
timeFrame: within the prior 7 days after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shanghai
country: China
facility: Shanghai East Hospital Tongji University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Yong-feng Shao
role: STUDY_DIRECTOR
References:
citation: Liu D, Yu Z, Yin J, Chen Y, Zhang H, Xin F, Fu H, Wan B. Effect of ulinastatin combined with thymosin alpha1 on sepsis: A systematic review and meta-analysis of Chinese and Indian patients. J Crit Care. 2017 Jun;39:259-266. doi: 10.1016/j.jcrc.2016.12.013. Epub 2016 Dec 27.