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

Study Overview
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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.

Official Title
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Effects of Ulinastatin on Inflammatory Response for Acute Aortic Syndrome Patients

Conditions
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Acute Aortic Syndrome, Type A Aortic Dissection

Intervention / Treatment
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* Drug: Ulinastatin
* Drug: Blank control


Participation Criteria
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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 emergency aortic arch replacement surgery were enrolled. The patients' age between 15  90 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulinastatin<br>Ulinastatin 10 0000 Units is taken intravenously three times a day. | Drug: Ulinastatin<br>* Ulinastatin is taken three times a day.<br>|
| Sham Comparator: Blank control<br>Blank control. | Drug: Blank control<br>* Blank control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death from any cause | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Aortic Syndrome