Clinical trial NCT05339529: Protective Effect of Thymosin Α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)
Official title: Protective Effect of Thymosin Α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Aortic Syndrome
Aortic Dissection Type a
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
name: Second Affiliated Hospital of Nanchang University
name: Qilu Hospital of Shandong University
name: The First Affiliated Hospital of Guangzhou Medical University
name: Northern Jiangsu People's Hospital
name: Guangdong Provincial People's Hospital
name: First Affiliated Hospital of Kunming Medical University
name: Nanjing First Hospital, Nanjing Medical University
name: Shanghai East Hospital,Tongji University School of Medicine
name: The Seventh Affiliated Hospital of Xinjiang Medical University
name: TEDA International Cardiovascular Hospital
name: The First Affiliated Hospital of Bengbu Medical University
name: West China Hospital
First posted: 2022-04-21
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 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.


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;
* 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 highest Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery
timeFrame: 7 days after surgery
Secondary outcomes:
measure: 30-day mortality
timeFrame: 30 days after randomization
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital Nanjing Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: Subei People's Hospital of Jiangsu Province
state: Jiangsu
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Kazak
country: China
facility: The Friendship Hospital of Yili Kazak Autonomous Prefecture
state: Xinjiang
city: Urumchi
country: China
facility: The Seventh Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Beijing
country: China
facility: Beijing Anzhen Hospital Capital Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Shanghai East Hospital Tongji University
city: Tianjin
country: China
facility: TEDA International Cardiovascular Hospital
Study officials:
affiliation: Nanjing Medical University
name: Hong Liu
role: PRINCIPAL_INVESTIGATOR
References: