RecruitingNot ApplicableNCT05339529

Protective Effect of Thymosin Α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)


Sponsor

Nanjing Medical University

Enrollment

330 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

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Interventions

DRUGThymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-

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.

DRUGBlank control

Blank control


Locations(15)

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 Friendship Hospital of Yili Kazak Autonomous Prefecture

Kazak, Xinjiang, China

The Seventh Affiliated Hospital of Xinjiang Medical University

Ürümqi, 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

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NCT05339529


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