Protective Effect of Thymosin Α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)
- Conditions
- Acute Aortic SyndromeAortic Dissection Type a
- Interventions
- Registration Number
- NCT05339529
- Lead Sponsor
- Nanjing Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 330
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thymosin alpha 1 Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine- 1.6 mg q12h for 5 days Blank control Blank control -
- Primary Outcome Measures
Name Time Method The highest Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery 7 days after surgery 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.
- Secondary Outcome Measures
Name Time Method 30-day mortality 30 days after randomization Death from any cause of 30 days after randomization
Trial Locations
- Locations (15)
The Friendship Hospital of Yili Kazak Autonomous Prefecture
🇨🇳Kazak, Xinjiang, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Nanjing First Hospital Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Subei People's Hospital of Jiangsu Province
🇨🇳Yangzhou, Jiangsu, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The Seventh Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumchi, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Beijing Anzhen Hospital Capital Medical University
🇨🇳Beijing, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Shanghai East Hospital Tongji University
🇨🇳Shanghai, China
TEDA International Cardiovascular Hospital
🇨🇳Tianjin, China