Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID05339529

Protective Effect of Thymosin Alpha 1 Against Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery

Led by Nanjing Medical University · Updated on 2024-12-12

330

Participants Needed

15

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Nanjing Medical University

Lead Sponsor

B

Beijing Anzhen Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are major causes of death in patients with acute aortic syndrome (AAS). Researchers are evaluating whether immunomodulatory therapy with thymosin alpha 1 during the acute phase of AAS can reduce the incidence of SIRS and MODS. This study is designed to test this hypothesis in patients undergoing emergency surgery for acute aortic syndrome. Participants will be randomly assigned to receive either thymosin alpha 1 or no additional treatment (blank control). Thymosin alpha 1 is given as a 1.6 mg injection under the skin every 12 hours for 5 days during ICU admission. The treatment will stop if the patient is discharged from the ICU or dies. This randomized study uses triple masking to compare the effects of thymosin alpha 1 versus no treatment. During the study, researchers will monitor patients for 7 days after surgery, focusing on the highest Sequential Organ Failure Assessment (SOFA) score as the main outcome. They will also track 30-day mortality after randomization. Participants will be closely observed in the ICU while receiving treatment, and their organ function and immune response will be assessed. The study lasts through the critical postoperative period to evaluate safety and health outcomes related to thymosin alpha 1 administration.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with thoracic aortic disease according to 2010 ACC/AHA guidelines within two weeks of onset
  • Patients with acute aortic syndrome confirmed clinically and by imaging, planning emergency surgery
  • Age between 18 and 90 years old
  • Agree to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Allergy to thymosin alpha 1
  • Pregnant or breastfeeding women
  • History of mental illness, drug, or alcohol dependence
  • Refusal to participate or sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 2 weeks before surgery

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) prior to surgery

Treatment

Duration - Up to 5 days or until ICU discharge or death

Participants receive Thymosin Alpha 1 injections or blank control every 12 hours for up to 5 days during ICU admission after acute aortic dissection surgery.

Twice daily injections during ICU stay

Follow-up

Duration - 30 days after randomization

Participants are monitored for organ function and survival outcomes for up to 30 days after randomization.

Periodic assessments during hospital stay and follow-up visits as scheduled

Trial Site Locations

Total: 15 locations

1

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Actively Recruiting

2

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Actively Recruiting

3

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Actively Recruiting

4

Nanjing First Hospital Nanjing Medical University

Nanjing, Jiangsu, China

Actively Recruiting

5

Subei People's Hospital of Jiangsu Province

Yangzhou, Jiangsu, China

Actively Recruiting

6

Qilu Hospital of Shandong University

Jinan, Shandong, China

Actively Recruiting

7

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Actively Recruiting

8

The Friendship Hospital of Yili Kazak Autonomous Prefecture

Kazak, Xinjiang, China

Actively Recruiting

9

The Seventh Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Actively Recruiting

10

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Actively Recruiting

11

Beijing Anzhen Hospital Capital Medical University

Beijing, China, 10029

Actively Recruiting

12

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Actively Recruiting

13

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Actively Recruiting

14

Shanghai East Hospital Tongji University

Shanghai, China

Actively Recruiting

15

TEDA International Cardiovascular Hospital

Tianjin, China

Actively Recruiting

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Research Team

H

Hong Liu, MD

H

Hong-jia Zhang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

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

Hong Liu, Si-Chong Qian, Ying-Yuan Zhang...

https://pubmed.ncbi.nlm.nih.gov/40367062