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Protective Effect of Ulinastatin Against Negative Inflammatory Response and Organ Dysfunction After Acute Type a Aortic Dissection Surgery (PANDA I)

NCT ID: NCT04711889

Last Updated: 2024-12-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Aortic Syndrome Type a Aortic Dissection

Keywords

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Acute Aortic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ulinastatin

Ulinastatin 10 0000 Units is taken intravenously three times a day.

Group Type EXPERIMENTAL

Ulinastatin

Intervention Type DRUG

Ulinastatin is taken three times a day.

Blank control

Blank control.

Group Type SHAM_COMPARATOR

Blank control

Intervention Type DRUG

Blank control

Interventions

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Ulinastatin

Ulinastatin is taken three times a day.

Intervention Type DRUG

Blank control

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 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hong Liu

Investigator of Nanjing Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The first affiliated hospital of nanjing medical university

Nanjing, Jiangsu, China

Site Status

Beijing Anzhen Hospital

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40026520 (View on PubMed)

Liu 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.

Reference Type DERIVED
PMID: 39842406 (View on PubMed)

Other Identifiers

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PANDA I

Identifier Type: -

Identifier Source: org_study_id