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/40367062Actively Recruiting
Led by Nanjing Medical University · Updated on 2024-12-12
330
Participants Needed
15
Research Sites
N/A
Total Duration
N
Nanjing Medical University
Lead Sponsor
B
Beijing Anzhen Hospital
Collaborating Sponsor
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
Protective Effect of Thymosin Α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)
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Complete this quick 3-step screening to check your eligibility
Duration - Up to 2 weeks before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) prior to surgery
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
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
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
H
Hong Liu, MD
H
Hong-jia Zhang, MD
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Hong Liu, Si-Chong Qian, Ying-Yuan Zhang...
https://pubmed.ncbi.nlm.nih.gov/40367062