NCT04711889

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

1.5 years

First QC Date

January 13, 2021

Last Update Submit

December 10, 2024

Conditions

Acute Aortic SyndromeType a Aortic Dissection

Keywords

Acute Aortic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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)

    mean SOFA score 7 days after surgery

Secondary Outcomes (1)

  • Mortality

    30 days after surgery

Study Arms (2)

Ulinastatin

EXPERIMENTAL

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

Drug: Ulinastatin

Blank control

SHAM COMPARATOR

Blank control.

Drug: Blank control

Interventions

UlinastatinDRUG

Ulinastatin is taken three times a day.

Ulinastatin
Blank controlDRUG

Blank control

Blank control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The first affiliated hospital of nanjing medical university

Nanjing, Jiangsu, 210029, China

Location

Beijing Anzhen Hospital

Beijing, China

Location

Related Publications (2)

  • 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.

    PMID: 40026520DERIVED

  • 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.

    PMID: 39842406DERIVED

MeSH Terms

Conditions

Acute Aortic Syndrome

Interventions

urinastatin

Condition Hierarchy (Ancestors)

Aortic DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator of Nanjing Medical University

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 15, 2021

Study Start

January 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

December 13, 2024

Record last verified: 2024-12

Locations

CN(2)