Acute Aortic SyndromePANDANCT04711889
Protective Effect of Ulinastatin Against Negative Inflammatory Response and Organ Dysfunction After Acute Type a Aortic Dissection Surgery (PANDA I)
A study testing Ulinastatin in people with Acute Aortic Syndrome and Type a Aortic Dissection, run by Nanjing Medical University at 2 sites in China.
Trial summary
Acute Aortic Syndrome (AAS) is a common feature of acute aortic wall events, including aortic dissection, intramural hematoma, aortic ulceration and aortic trauma, and occurs in up to 35 cases per 100,000 cases per year between the ages of 65 and 75 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Aortic Syndrome, Type a Aortic Dissection
- What is being tested?
- Ulinastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2021to 30 Jun 2022
- 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 years and older
- 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 type a acute aortic syndrome confirmed clinically and radiologically and planning to undergo aortic surgery were enrolled.
- The patients' age of 18 years or older.
- Agree to participate in the study and sign the informed consent.
Who cannot join
- Patients allergic to Ulinastatin;
- Lactating women and pregnant women;
- Patients with mental diseases;
- Refuse to participate in this study and refuse to sign the informed consent.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Anzhen Hospital
Beijing
The first affiliated hospital of nanjing medical university
Nanjing, Jiangsu, 210029
About this study
Acute Aortic Syndrome (AAS) is a common feature of acute aortic wall events, including aortic dissection, intramural hematoma, aortic ulceration and aortic trauma, and occurs in up to 35 cases per 100,000 cases per year between the ages of 65 and 75 years. Ulinastatin has antiinflammatory activity and suppresses the infiltration of neutrophils and the release of elastase and chemical mediators from neutrophils. Recent studies have shown that ulinastatin may be cytoprotective against ischemia-reperfusion injury in the liver, kidney, heart, and lung. The authors aim to examine the association between decreased release of inflammatory response to urinary trypsin inhibitor treatment and decreased myocardial and lung injury after acute aortic syndrome surgery.
- Conditions
- Acute Aortic Syndrome, Type a Aortic Dissection
- Being tested
- Ulinastatin, Blank control
- Keywords
- Acute Aortic Syndrome
- 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.
UlinastatinDrug
Ulinastatin is taken three times a day.
Blank controlDrug
Blank control
| Study group | Role | What they receive |
|---|---|---|
| Ulinastatin | Experimental | Ulinastatin 10 0000 Units is taken intravenously three times a day. Receives: Drug: Ulinastatin |
| Blank control | Sham comparator | Blank control. Receives: Drug: Blank control |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA score
The daily SOFA score after baseline was calculated for each patient on the basis of organ systems: neurologic, cardiovascular, respiratory, renal, hepatic, and coagulation systems. (Scores for each system range from 0 to 4, with higher scores indicating more severe organ-system dysfunction)
Measured: mean SOFA score 7 days after surgery
Secondary outcomes (1)
Mortality
Death from any cause
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711889
- Sponsor's protocol ID
- PANDA I
- Acronym
- PANDA
- Status last verified
- Dec 2024
- First submitted
- 13 Jan 2021
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Diao YF, Chen ZB, Gu JX, Xu XY, Lin WF, Yuan CZ, Xiong JQ, Li MH, Ni BQ, Zhao S, Shao YF, Zhang YY, Liu H. Incorporating Circulating Plasma Interleukin-10 Enhanced Risk Predictability of Mortality in Acute Type A Aortic Dissection Surgery. Rev Cardiovasc Med. 2025 Feb 21;26(2):26334. doi: 10.31083/RCM26334. eCollection 2025 Feb.
PubMed 40026520Liu H, Qian SC, Zhu K, Diao YF, Xu XF, Tang ZW, Fan GL, Yue HH, Chen JQ, Yang JN, Zhang YY, Ma C, Liu X, Wu Y, Wu Z, Liu N, Li A, Ni BQ, Shao YF, Zhao S, Li HY, Zhang HJ; China Additive Anti-inflammatory Actions for Aortopathy and Arteriopathy (5A); PANDA Trial Investigators. Protective effect of ulinastatin against negative inflammatory response and organ dysfunction in acute aortic dissection surgery: The PANDA trial. Cell Rep Med. 2025 Jan 21;6(1):101888. doi: 10.1016/j.xcrm.2024.101888.
PubMed 39842406
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Ulinastatin Against Negative Inflammatory Response and Organ Dysfunction After Acute Type a Aortic Dissection Surgery (PANDA I)
- ClinicalTrials.gov ID
- NCT04711889
- Acronym / sponsor ID
- PANDA / PANDA I
- Conditions
- Acute Aortic Syndrome, Type a Aortic Dissection
- Keywords
- Acute Aortic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 15 Jan 2021 (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.
Acute Aortic Syndrome (AAS) is a common feature of acute aortic wall events, including aortic dissection, intramural hematoma, aortic ulceration and aortic trauma, and occurs in up to 35 cases per 100,000 cases per year between the ages of 65 and 75 years. Ulinastatin has antiinflammatory activity and suppresses the infiltration of neutrophils and the release of elastase and chemical mediators from neutrophils. Recent studies have shown that ulinastatin may be cytoprotective against ischemia-reperfusion injury in the liver, kidney, heart, and lung. The authors aim to examine the association between decreased release of inflammatory response to urinary trypsin inhibitor treatment and decreased myocardial and lung injury after acute aortic syndrome surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulinastatin | Experimental | Drug: UlinastatinUlinastatin 10 0000 Units is taken intravenously three times a day. |
| Blank control | Sham comparator | Drug: Blank controlBlank control. |
Who may qualify
- Ages
- 18 years and older
- 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 type a acute aortic syndrome confirmed clinically and radiologically and planning to undergo aortic surgery were enrolled.
- The patients' age of 18 years or older.
- Agree to participate in the study and sign the informed consent.
Key exclusion criteria (4 listed)
- Patients allergic to Ulinastatin;
- Lactating women and pregnant women;
- Patients with mental diseases;
- 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 |
|---|---|---|
| UlinastatinUlinastatin is taken three times a day. | Drug | Ulinastatin |
| Blank controlBlank control | Drug | Blank control |
Primary outcome
SOFA score
Time frame: mean SOFA score 7 days after surgery
The daily SOFA score after baseline was calculated for each patient on the basis of organ systems: neurologic, cardiovascular, respiratory, renal, hepatic, and coagulation systems. (Scores for each system range from 0 to 4, with higher scores indicating more severe organ-system dysfunction)
1 secondary outcome
Mortality
Time frame: 30 days after surgery
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 13 Dec 2024.
- Derived from this study: PubMed 40026520Diao YF, Chen ZB, Gu JX, Xu XY, Lin WF, Yuan CZ, Xiong JQ, Li MH, Ni BQ, Zhao S, Shao YF, Zhang YY, Liu H. Incorporating Circulating Plasma Interleukin-10 Enhanced Risk Predictability of Mortality in Acute Type A Aortic Dissection Surgery. Rev Cardiovasc Med. 2025 Feb 21;26(2):26334. doi: 10.31083/RCM26334. eCollection 2025 Feb.
- Derived from this study: PubMed 39842406Liu H, Qian SC, Zhu K, Diao YF, Xu XF, Tang ZW, Fan GL, Yue HH, Chen JQ, Yang JN, Zhang YY, Ma C, Liu X, Wu Y, Wu Z, Liu N, Li A, Ni BQ, Shao YF, Zhao S, Li HY, Zhang HJ; China Additive Anti-inflammatory Actions for Aortopathy and Arteriopathy (5A); PANDA Trial Investigators. Protective effect of ulinastatin against negative inflammatory response and organ dysfunction in acute aortic dissection surgery: The PANDA trial. Cell Rep Med. 2025 Jan 21;6(1):101888. doi: 10.1016/j.xcrm.2024.101888.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulinastatin in people with Acute Aortic Syndrome and Type a Aortic Dissection, run by Nanjing Medical University at 2 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 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
SOFA score (time frame: mean SOFA score 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 NCT04711889, which also lists 2 linked publications.
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 13 Dec 2024.