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| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
| Second Affiliated Hospital of Nanchang University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thymosin alpha 1 | Experimental | 1.6 mg q12h for 5 days |
|
| Blank control | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine- | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The highest Sequential Organ Failure Assessment (SOFA) score of 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. | 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | Death from any cause of 30 days after randomization | 30 days after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Liu, MD | Contact | 8618801281613 | DR.HONGLIU@FOXMAIL.COM | |
| Hong-jia Zhang, MD | Contact | 8601068303105 | zhanghongjia722@ccmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hong Liu | Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Recruiting | Bengbu | Anhui | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40367062 | Derived | Liu H, Qian SC, Zhang YY, Tang CB, Yue HH, Fan GL, Zhao X, Jiang YY, Huang FH, Zeng ZH, Wang W, Lu XR, Luo XK, Bai XF, Zheng XX, Xie P, Ma C, Zhao S, Zhang HJ; On the behalf of China Additive Anti-inflammatory Actions for Aortopathy and Arteriopathy (5A) and PANDA Trial Investigators. Effect of thymosin alpha1 on Immune response and organ function in acute aortic dissection surgery: PANDA II trial protocol. Future Cardiol. 2025 Jun;21(7):447-454. doi: 10.1080/14796678.2025.2505401. Epub 2025 May 14. |
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| OTHER |
| Northern Jiangsu People's Hospital | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| First Affiliated Hospital of Kunming Medical University | OTHER |
| Nanjing First Hospital, Nanjing Medical University | OTHER |
| Shanghai East Hospital of Tongji University | OTHER |
| The Seventh Affiliated Hospital of Xinjiang Medical University | UNKNOWN |
| TEDA International Cardiovascular Hospital | OTHER |
| The First Affiliated Hospital of Bengbu Medical University | OTHER |
| West China Hospital | OTHER |
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|
| Blank control | Drug | Blank control |
|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
|
| Nanjing First Hospital Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
|
| Subei People's Hospital of Jiangsu Province | Recruiting | Yangzhou | Jiangsu | China |
|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | China |
|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
|
| The Friendship Hospital of Yili Kazak Autonomous Prefecture | Recruiting | Kazak | Xinjiang | China |
|
| The Seventh Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang | China |
|
| The First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | China |
|
| Beijing Anzhen Hospital Capital Medical University | Recruiting | Beijing | 10029 | China |
|
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | China |
|
| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
|
| Shanghai East Hospital Tongji University | Recruiting | Shanghai | China |
|
| TEDA International Cardiovascular Hospital | Recruiting | Tianjin | China |
|
| ID | Term |
|---|---|
| D000094683 | Acute Aortic Syndrome |
| ID | Term |
|---|---|
| D001018 | Aortic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077596 | Thymalfasin |
| ID | Term |
|---|---|
| D013947 | Thymosin |
| D013951 | Thymus Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
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