Thymosin Alpha1 for preventing immune issues after aortic dissection surgery

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

This study tests whether thymosin alpha 1 can help prevent serious immune problems in patients having emergency surgery for aortic dissection.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 330 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Nanjing Medical University (Academic / other)
• Locations: 15 sites (Bengbu, Anhui and 14 other locations)
• Trial ID: NCT05339529 on ClinicalTrials.gov

What this trial studies

This study investigates the use of thymosin alpha 1 to prevent systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) in patients undergoing emergency surgery for acute aortic syndrome. By administering thymosin alpha 1 during the acute phase, the researchers aim to reduce the incidence of these serious complications. The study will enroll patients who meet specific criteria related to thoracic aortic disease and are scheduled for surgery. Participants will be compared against a control group receiving a blank treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 who have been diagnosed with acute aortic syndrome and are planning to undergo emergency surgery.

Not a fit: Patients with allergies to thymosin alpha 1, pregnant or lactating women, and those with mental health issues or substance dependence may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of severe complications and improve recovery outcomes for patients undergoing surgery for acute aortic syndrome.

How similar studies have performed: While the use of immunomodulatory therapies is a growing field, this specific application of thymosin alpha 1 in the context of acute aortic syndrome is relatively novel.

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.

Where this trial is running

Bengbu, Anhui and 14 other locations

• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (Recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
• Nanjing First Hospital Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
• Subei People's Hospital of Jiangsu Province — Yangzhou, Jiangsu, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• The Friendship Hospital of Yili Kazak Autonomous Prefecture — Kazak, Xinjiang, China (Recruiting)
• The Seventh Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
• Beijing Anzhen Hospital Capital Medical University — Beijing, China (Recruiting)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, China (Recruiting)
• The Second Affiliated Hospital of Nanchang University — Nanchang, China (Recruiting)
• Shanghai East Hospital Tongji University — Shanghai, China (Recruiting)
• TEDA International Cardiovascular Hospital — Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Hong Liu — Nanjing Medical University
• Study coordinator: Hong Liu, MD

Conditions Acute Aortic Syndrome; Aortic Dissection Type a