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

Sponsor

Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04711889

Collaborator

Beijing Anzhen Hospital (Other)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

100

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 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 :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Oxygenation index [3 days after surgery]
Oxygenation index is calculated as PaO2/FiO2.

Secondary Outcome Measures

Mortality [30 days after surgery]
Death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of nanjing medical university	Nanjing	Jiangsu	China	210029
2	Beijing Anzhen Hospital	Beijing		China

Sponsors and Collaborators

Nanjing Medical University
Beijing Anzhen Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jan 15, 2021

Last Update Posted:

Aug 12, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hong Liu, Investigator of Nanjing Medical University, Nanjing Medical University

Acute Aortic Syndrome

Additional relevant MeSH terms:

Aneurysm, Dissecting

Syndrome

Urinastatin

Study Results

No Results Posted as of Aug 12, 2021