Acute Aortic SyndromePANDANCT05339529
Protective Effect of Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)
A study testing Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine- in people with Acute Aortic Syndrome and Aortic Dissection Type A, run by Nanjing Medical University at 15 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Aortic Syndrome, Aortic Dissection Type A
- What is being tested?
- Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 15 sitesChina
- Study dates
- 1 Jul 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Beijing Anzhen Hospital Capital Medical University
Beijing, 10029
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
West China Hospital of Sichuan University
Chengdu, Sichuan
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Qilu Hospital of Shandong University
Jinan, Shandong
The Friendship Hospital of Yili Kazak Autonomous Prefecture
Kazak, Xinjiang
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
The Second Affiliated Hospital of Nanchang University
Nanchang
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Nanjing First Hospital Nanjing Medical University
Nanjing, Jiangsu
Shanghai East Hospital Tongji University
Shanghai
TEDA International Cardiovascular Hospital
Tianjin
The Seventh Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Subei People's Hospital of Jiangsu Province
Yangzhou, Jiangsu
About this study
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.
- Conditions
- Acute Aortic Syndrome, Aortic Dissection Type A
- Being tested
- 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
- Medical subject headings
- Acute Aortic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-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 controlDrug
Blank control (Standard care control; no placebo or sham thymosin alpha 1 injections were administered.)
| Study group | Role | What they receive |
|---|---|---|
| Thymosin alpha 1 | Experimental | 1.6 mg q12h for 5 days Receives: Drug: 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 | Other | Standard care control; no placebo or sham thymosin alpha 1 injections were administered. Receives: Drug: Blank control |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day postoperative organ dysfunction burden assessed by mean daily SOFA score
The primary outcome is early postoperative organ dysfunction burden, quantified as the mean daily Sequential Organ Failure Assessment (SOFA) score over postoperative days 1-7 using a fixed 7-day assessment window. Higher scores indicate greater organ dys
Measured: 7 days after surgery
Secondary outcomes (1)
30-day mortality
Death from any cause of 30 days after randomization
Measured: 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Jul 2022
- Primary completion31 Mar 2025
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Aortic SyndromeStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- 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 of Tongji University, The Seventh Affiliated Hospital of Xinjiang Medical University, TEDA International Cardiovascular Hospital, The First Affiliated Hospital of Bengbu Medical University, West China Hospital
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
- Investigators
- Hong Liu, Principal investigator, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339529
- Sponsor's protocol ID
- PANDA II
- Acronym
- PANDA
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40367062
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)
- ClinicalTrials.gov ID
- NCT05339529
- Acronym / sponsor ID
- PANDA / PANDA II
- Conditions
- Acute Aortic Syndrome, Aortic Dissection Type A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- 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 of Tongji University, The Seventh Affiliated Hospital of Xinjiang Medical University, TEDA International Cardiovascular Hospital, The First Affiliated Hospital of Bengbu Medical University, West China Hospital
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymosin alpha 1 | Experimental | Drug: Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-1.6 mg q12h for 5 days |
| Blank control | Other | Drug: Blank controlStandard care control; no placebo or sham thymosin alpha 1 injections were administered. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Thymosin alpha 1 |
| Blank controlBlank control (Standard care control; no placebo or sham thymosin alpha 1 injections were administered.) | Drug | Blank control |
Primary outcome
7-day postoperative organ dysfunction burden assessed by mean daily SOFA score
Time frame: 7 days after surgery
The primary outcome is early postoperative organ dysfunction burden, quantified as the mean daily Sequential Organ Failure Assessment (SOFA) score over postoperative days 1-7 using a fixed 7-day assessment window. Higher scores indicate greater organ dys
1 secondary outcome
30-day mortality
Time frame: 30 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 40367062Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Liu principal investigator
Nanjing Medical University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine- in people with Acute Aortic Syndrome and Aortic Dissection Type A, run by Nanjing Medical University at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day postoperative organ dysfunction burden assessed by mean daily SOFA score (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05339529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.