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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Aortic Syndrome Aortic Dissection Type a

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Thymosin alpha 1

1.6 mg q12h for 5 days

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Blank control

Group Type SHAM_COMPARATOR

Blank control

Intervention Type DRUG

Blank control

Interventions

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Thymosin 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.

Intervention Type DRUG

Blank control

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Hong Liu

Principal Investigator of Cardiovascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Liu

Role: PRINCIPAL_INVESTIGATOR

Nanjing Medical University

Locations

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The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Nanjing First Hospital Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Subei People's Hospital of Jiangsu Province

Yangzhou, Jiangsu, China

Site Status RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

The Friendship Hospital of Yili Kazak Autonomous Prefecture

Kazak, Xinjiang, China

Site Status RECRUITING

The Seventh Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status RECRUITING

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status RECRUITING

Beijing Anzhen Hospital Capital Medical University

Beijing, , China

Site Status RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, , China

Site Status RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status RECRUITING

Shanghai East Hospital Tongji University

Shanghai, , China

Site Status RECRUITING

TEDA International Cardiovascular Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Liu, MD

Role: CONTACT

Phone: 8618801281613

Email: [email protected]

Hong-jia Zhang, MD

Role: CONTACT

Phone: 8601068303105

Email: [email protected]

Facility Contacts

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Yi-yao Jiang, MD

Role: primary

Yi-yao Jiang, MD

Role: backup

Xiao-kang Luo, MD

Role: primary

Xiao-kang Luo, MD

Role: backup

Hong Liu, MD

Role: primary

Sheng Zhao, MD

Role: backup

Hong Liu, MD

Role: backup

Fu-hua Huang, MD

Role: primary

Fu-hua Huang, MD

Role: backup

Cheng-bin Tang, MD

Role: primary

Cheng-bin Tang, MD

Role: backup

Xin Zhao, MD

Role: primary

Xin Zhao, MD

Role: backup

Hong-hua Yue, MD

Role: primary

Zhong Wu, MD

Role: backup

Hong-hua Yue, MD

Role: backup

Xiang-xiang Zheng, MD

Role: primary

Xiang-xiang Zheng, MD

Role: backup

Xu-ran Lu, MD

Role: primary

Xu-ran Lu, MD

Role: backup

Xiang-feng Bai, MD

Role: primary

Xiang-feng Bai, MD

Role: backup

Si-chong Qian

Role: primary

Hai-yang LI

Role: backup

Si-chong Qian, MD

Role: backup

Ying-yuan Zhang

Role: primary

Ying-yuan Zhang, MD

Role: backup

Zhi-hua Zeng, MD

Role: primary

Zhi-hua Zeng, MD

Role: backup

Guo-liang Fan, MD

Role: primary

Guo-liang Fan, MD

Role: backup

Lei Xi, MD

Role: primary

Lei Xi, MD

Role: backup

References

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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.

Reference Type DERIVED

PMID: 40367062 (View on PubMed)

Other Identifiers

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PANDA II

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Thymosin alpha 1

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

Blank control

Blank control

Interventions

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

Blank control

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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,Tongji University School of Medicine

The Seventh Affiliated Hospital of Xinjiang Medical University

TEDA International Cardiovascular Hospital

The First Affiliated Hospital of Bengbu Medical University

West China Hospital

Nanjing Medical University

Responsible Party

Hong Liu

Principal Investigators

Hong Liu

Locations

The First Affiliated Hospital of Bengbu Medical College

Guangdong Provincial People's Hospital

The First Affiliated Hospital of Nanjing Medical University

Nanjing First Hospital Nanjing Medical University

Subei People's Hospital of Jiangsu Province

Qilu Hospital of Shandong University

West China Hospital of Sichuan University

The Friendship Hospital of Yili Kazak Autonomous Prefecture

The Seventh Affiliated Hospital of Xinjiang Medical University

The First Affiliated Hospital of Kunming Medical University

Beijing Anzhen Hospital Capital Medical University

The First Affiliated Hospital of Guangzhou Medical University

The Second Affiliated Hospital of Nanchang University

Shanghai East Hospital Tongji University

TEDA International Cardiovascular Hospital

Countries

Central Contacts

Hong Liu, MD

Hong-jia Zhang, MD

Facility Contacts

Yi-yao Jiang, MD

Yi-yao Jiang, MD

Xiao-kang Luo, MD

Xiao-kang Luo, MD

Hong Liu, MD

Sheng Zhao, MD

Hong Liu, MD

Fu-hua Huang, MD

Fu-hua Huang, MD

Cheng-bin Tang, MD

Cheng-bin Tang, MD

Xin Zhao, MD

Xin Zhao, MD

Hong-hua Yue, MD

Zhong Wu, MD

Hong-hua Yue, MD

Xiang-xiang Zheng, MD

Xiang-xiang Zheng, MD

Xu-ran Lu, MD

Xu-ran Lu, MD

Xiang-feng Bai, MD

Xiang-feng Bai, MD