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CompletedNCT05339529PANDAUpdated Sep 14, 2026

Protective Effect of Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)

An interventional study of Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine- and Blank control in Acute Aortic Syndrome and Aortic Dissection Type A, sponsored by Nanjing Medical University. Completed at 15 sites in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Acute Aortic Syndrome
  • Aortic Dissection Type A
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In context

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
600 participants (actual)

Study arms

  • Experimental
    Thymosin alpha 1

    1.6 mg q12h for 5 days

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

  • Other
    Blank control

    Standard care control; no placebo or sham thymosin alpha 1 injections were administered.

    Drug: Blank control

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 (Standard care control; no placebo or sham thymosin alpha 1 injections were administered.)

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What researchers measure

Primary outcomes

  1. 7-day postoperative organ dysfunction burden assessed by mean daily SOFA score

    The primary outcome is early postoperative organ dysfunction burden, quantified as the mean daily Sequential Organ Failure Assessment (SOFA) score over postoperative days 1-7 using a fixed 7-day assessment window. Higher scores indicate greater organ dys

    Time frame: 7 days after surgery

Secondary outcomes

  1. 30-day mortality

    Death from any cause of 30 days after randomization

    Time frame: 30 days after randomization

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Study locations

15 sites
  • 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 210029, 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, 10029, 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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References and documents

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 protocol. Future Cardiol. 2025 Jun;21(7):447-454. doi: 10.1080/14796678.2025.2505401. Epub 2025 May 14. PubMed 40367062 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05339529
Lead sponsor
Nanjing Medical University
Collaborators
Beijing Anzhen Hospital, Second Affiliated Hospital of Nanchang University, Qilu Hospital of Shandong University, The First Affiliated Hospital of Guangzhou Medical University, Northern Jiangsu People's Hospital, Guangdong Provincial People's Hospital, First Affiliated Hospital of Kunming Medical University, Nanjing First Hospital, Nanjing Medical University, Shanghai East Hospital of Tongji University, The Seventh Affiliated Hospital of Xinjiang Medical University, TEDA International Cardiovascular Hospital, The First Affiliated Hospital of Bengbu Medical University, West China Hospital
Responsible party
Hong Liu (Principal Investigator of Cardiovascular Surgery, Nanjing Medical University) — Principal investigator
First posted
Apr 21, 2022
Start date
Jul 1, 2022
Primary completion
Mar 31, 2025
Completion
Jul 31, 2026
Last update
Sep 14, 2026

Study contacts

Hong Liu
principal investigator · Nanjing Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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