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Recruiting NCT05339529

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

No phase Interventional Acute Aortic Syndrome Aortic Dissection Type a

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-, Blank control.
Who it may be relevant to
Registry conditions: Acute Aortic Syndrome, Aortic Dissection Type a. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Thymosin 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.
  • Drug Blank control
    Blank control

Primary outcome measures

  • The highest Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery [Time frame: 7 days after surgery]
Secondary outcome measures (1)
  • 30-day mortality [Time frame: 30 days after randomization]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

China · 15 centers
  • The First Affiliated Hospital of Bengbu Medical College — Bengbu
  • Guangdong Provincial People's Hospital — Guangzhou
  • The First Affiliated Hospital of Nanjing Medical University — Nanjing
  • Nanjing First Hospital Nanjing Medical University — Nanjing
  • Subei People's Hospital of Jiangsu Province — Yangzhou
  • Qilu Hospital of Shandong University — Jinan
  • West China Hospital of Sichuan University — Chengdu
  • The Friendship Hospital of Yili Kazak Autonomous Prefecture — Kazak
  • … and 7 more centers

Publications

  • 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 PMID 40367062

Identifiers

NCT: NCT05339529 · PANDA II

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗