- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01894334
Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection
Mechanism and Early Intervention Research on Acute Lung Injury During Emergence Surgery of Acute Stanford A Aortic Dissection
The morbidity rate of Stanford A type Acute Aortic Dissection(AAD) has been increasing, about 5-10/100,000* per year. Emergency surgery has been the main treatment for Acute Aortic Dissection, however perioperative mortality rate can be as high as 15~30%. Acute lung injury (ALI) is one of the main complications that happen during the perioperative period, which by itself covers 30%-50% of the overall mortality rate. Both domestic and foreign countries lack researches on risk factors, pathogenesis, disease progression and outcome of ALI, which happen during the perioperative period of Acute Aortic Dissection patients.
This topic study follow projects in the preoperative of Acute Aortic Dissection'surgery
- hemodynamic changes (aortic dissection resulting in acute aortic regurgitation, cardiac tamponade and proximal high blood pressure)
- ischemia - reperfusion injury of aortic dissection distal organ
- Aortic intima-media exposure cause coagulation / fibrinolytic system function disorder
- systemic inflammatory response syndrome; use relevant clinical radiographic parameters, indicators of respiratory mechanics (oxygenation index and lung injury index) and biochemical indicators.
To discuss risk factors and possible mechanisms of ADD patients with pre-operative ALI and observe their influences on the progress and prognosis of AAD, to explore early intervention in the preoperative for possible risk factors and mechanisms and to evaluate their influences on the prognosis, to achieve the purpose of reducing AAD perioperative mortality of ALI and medical expenses.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- AAD patients within 48 hrs of onset who are prepared for aortic surgery
- Age between 18 and 70
- Willing to sign the informed consent
Exclusion Criteria:
- A history of chronic respiratory disease before onset
- A history of chronic heart failure or coronary heart disease before onset
- A history of chronic liver or kidney dysfunction before onset
- Severe central nervous system syndrome after admission
- Refuse to sign the informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
no intervention
|
|
Experimental: Tranexamic acid group
tranexamic acid ,intravenous 30mg/kg/d,Preoperative
|
|
Experimental: Edaravone group
edaravone, iv, 1mg/kg/d,Preoperative
|
|
Experimental: Ulinastatin group
Ulinastatin ,iv,20,000 U /kg/d,Preoperative
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
perioperative outcome and improve of ALI
Time Frame: Period from 48 hours before surgery to 12 hours after ICU
|
indicators
|
Period from 48 hours before surgery to 12 hours after ICU
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
systemic inflammatory response
Time Frame: Period from 48 hours before surgery to 12 hours after ICU
|
Indicators
|
Period from 48 hours before surgery to 12 hours after ICU
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: WeiPing Cheng, master, Chief Physician,Professor
Publications and helpful links
General Publications
- Gao Z, Pei X, He C, Wang Y, Lu J, Jin M, Cheng W. Oxygenation impairment in patients with acute aortic dissection is associated with disorders of coagulation and fibrinolysis: a prospective observational study. J Thorac Dis. 2019 Apr;11(4):1190-1201. doi: 10.21037/jtd.2019.04.32.
- Pan X, Lu J, Cheng W, Yang Y, Zhu J, Jin M. Independent factors related to preoperative acute lung injury in 130 adults undergoing Stanford type-A acute aortic dissection surgery: a single-center cross-sectional clinical study. J Thorac Dis. 2018 Jul;10(7):4413-4423. doi: 10.21037/jtd.2018.06.140.
- Cheng Y, Jin M, Dong X, Sun L, Liu J, Wang R, Yang Y, Lin P, Hou S, Ma Y, Wang Y, Pan X, Lu J, Cheng W. Mechanism and early intervention research on ALI during emergence surgery of Stanford type-A AAD: Study protocol for a prospective, double-blind, clinical trial. Medicine (Baltimore). 2016 Oct;95(42):e5164. doi: 10.1097/MD.0000000000005164.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Lung Injury
- Aneurysm
- Aneurysm, Dissecting
- Acute Lung Injury
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrin Modulating Agents
- Protease Inhibitors
- Neuroprotective Agents
- Protective Agents
- Serine Proteinase Inhibitors
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Trypsin Inhibitors
- Antioxidants
- Free Radical Scavengers
- Edaravone
- Tranexamic Acid
- Urinastatin
Other Study ID Numbers
- 2011-2006-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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