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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04711889
Recruitment Status : Completed
First Posted : January 15, 2021
Last Update Posted : February 2, 2023
Beijing Anzhen Hospital
Information provided by (Responsible Party):
Hong Liu, Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Acute Aortic Syndrome Aortic Dissection Drug: Ulinastatin Drug: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ulinastatin on Inflammatory Response for Acute Aortic Syndrome Patients
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : June 30, 2022
Actual Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ulinastatin
Ulinastatin 10 0000 Units is taken intravenously three times a day.
Drug: Ulinastatin
Ulinastatin is taken three times a day.

Placebo Comparator: Saline
Same saline dose as ulinastatin is taken intravenously three times a day.
Drug: Saline
Saline is taken three times a day.

Primary Outcome Measures :
  1. Oxygenation index [ Time Frame: 3 days after surgery ]
    Oxygenation index is calculated as PaO2/FiO2.

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days after surgery ]
    Death from any cause

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711889

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China, Jiangsu
The first affiliated hospital of nanjing medical university
Nanjing, Jiangsu, China, 210029
Beijing Anzhen Hospital
Beijing, China
Sponsors and Collaborators
Nanjing Medical University
Beijing Anzhen Hospital
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Responsible Party: Hong Liu, Investigator of Nanjing Medical University, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04711889    
Other Study ID Numbers: 5A-Plan II
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hong Liu, Nanjing Medical University:
Acute Aortic Syndrome
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action