Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Jun;21(7):447-454.
doi: 10.1080/14796678.2025.2505401. Epub 2025 May 14.

Effect of thymosin α1 on Immune response and organ function in acute aortic dissection surgery: PANDA II trial protocol

Hong Liu  1 , Si-Chong Qian  2 , Ying-Yuan Zhang  3 , Cheng-Bin Tang  4 , Hong-Hua Yue  5 , Guo-Liang Fan  6 , Xin Zhao  7 , Yi-Yao Jiang  8 , Fu-Hua Huang  9 , Zhi-Hua Zeng  10 , Wei Wang  11 , Xu-Ran Lu  12 , Xiao-Kang Luo  13 , Xiang-Feng Bai  14 , Xiang-Xiang Zheng  15 , Peng Xie  16 , Chao Ma  17 , Sheng Zhao  1 , Hong-Jia Zhang  2 ; On the behalf of China Additive Anti-inflammatory Actions for Aortopathy and Arteriopathy (5A) and PANDA Trial Investigators
Affiliations
Randomized Controlled Trial

Effect of thymosin α1 on Immune response and organ function in acute aortic dissection surgery: PANDA II trial protocol

Hong Liu et al. Future Cardiol. 2025 Jun.

Abstract

This multicenter randomized controlled trial evaluates the efficacy of thymosin alpha 1 (Tα1) supplementation in preventing organ dysfunction following acute type A aortic dissection (ATAAD) repair. Over 330 patients will be equally assigned to receive either Tα1 plus standard care or placebo with standard management. The primary endpoint involves calculating the difference in mean postoperative Sequential Organ Failure Assessment (SOFA) scores between groups, measured daily from postoperative days 7. By targeting post-operative immune system imbalance, this study aims to establish a novel therapeutic approach for reducing systemic inflammatory response syndrome (SIRS)-mediated organ injury and improving long-term outcomes in this high-risk population. Results will be disseminated through peer-reviewed publications and international conferences.Trial registration: ClinicalTrials.gov Registry (NCT05339529).

Keywords: Aortic dissection; immune; inflammation; mortality; thymosin alpha 1.

Plain language summary

Patients who undergo surgery for a serious heart condition called acute type A aortic dissection (ATAAD) often face life-threatening problems after surgery due to a disrupted immune response and damage to their organs. This study aims to see if giving a medicine called thymosin alpha 1, which helps support the immune system, can reduce these complications. In this study, eligible patients will be randomly assigned to receive either standard treatment or standard treatment plus thymosin alpha 1. Researchers will then compare how their organ function changes after surgery using a scoring system called the SOFA score. They will also look at other health outcomes, like survival, organ problems, and the need for additional treatments, both during the hospital stay and up to 6 months after surgery. The goal is to find out if thymosin alpha 1 can safely and effectively improve recovery by helping the immune system work better after this major heart surgery.

PubMed Disclaimer

Conflict of interest statement

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Similar articles

See all similar articles

References

    1. Carrel T, Sundt TM 3rd, von Kodolitsch Y, et al. Acute aortic dissection. Lancet. 2023;401(10378):773–788. doi: 10.1016/S0140-6736(22)01970-5 - DOI - PubMed
    1. Rylski B, Schilling O, Czerny M.. Acute aortic dissection: evidence, uncertainties, and future therapies. Eur Heart J. 2023;44(10):813–821. doi: 10.1093/eurheartj/ehac757 - DOI - PubMed
    1. Liu H, Han L, Zhang Y, et al. Inflammatory risk stratification individualizes anti-inflammatory pharmacotherapy for acute type a aortic dissection. Innovation. 2023;4(4):100448. doi: 10.1016/j.xinn.2023.100448 - DOI - PMC - PubMed

    2. •• Describes the goal and importance of anti-inflammatory pharmacotherapy for acute type A aortic dissection.

    1. Liu H, Diao YF, Shao YF, et al. Prognostic implication of residual inflammatory trajectories in acute type I aortic dissection: dual-center prospective cohort study. Int J Surg. 2024;110(6):3346–3356. doi: 10.1097/JS9.0000000000001245 - DOI - PMC - PubMed
    1. Liu H, Diao YF, Xu XF, et al. Inflammatory trajectory and anti-inflammatory pharmacotherapy in frozen elephant trunk-treated acute type I aortic dissection. J Soc Cardiovasc Angiogr Interv. 2024;3(7):101935. doi: 10.1016/j.jscai.2024.101935 - DOI - PMC - PubMed

    2. • Supports the methodology used in the current study.

Publication types

MeSH terms

Associated data