Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Ulinastatin) II

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    200
  • sponsor
    Nanjing Medical University
Updated on 22 August 2021
artery diseases

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.

Details
Condition Aortic Dissection, Acute Aortic Syndrome, Aneurysm
Treatment Saline, ulinastatin
Clinical Study IdentifierNCT04711889
SponsorNanjing Medical University
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

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 aortic arch replacement surgery were enrolled
The patients' age between 15 ~85 years old
Agree to participate in the study and sign the informed consent

Exclusion Criteria

Patients allergic to Ulinastatin
Patients with active or acute liver disease
Patients with chronic kidney disease
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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