Overview

This trial is active, not recruiting.

Condition acute aortic dissection
Treatments ulinastatin, tranexamic acid, edaravone
Sponsor Beijing Anzhen Hospital
Start date April 2013
End date January 2015
Trial size 220 participants
Trial identifier NCT01894334, 2011-2006-03

Summary

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

1. hemodynamic changes (aortic dissection resulting in acute aortic regurgitation, cardiac tamponade and proximal high blood pressure)

2. ischemia - reperfusion injury of aortic dissection distal organ

3. Aortic intima-media exposure cause coagulation / fibrinolytic system function disorder

4. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
no intervention
(Experimental)
tranexamic acid ,intravenous 30mg/kg/d,Preoperative
tranexamic acid
(Experimental)
edaravone, iv, 1mg/kg/d,Preoperative
edaravone
(Experimental)
Ulinastatin ,iv,20,000 U /kg/d,Preoperative
ulinastatin

Primary Outcomes

Measure
perioperative outcome and improve of ALI
time frame: Period from 48 hours before surgery to 12 hours after ICU

Secondary Outcomes

Measure
systemic inflammatory response
time frame: Period from 48 hours before surgery to 12 hours after ICU

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Mechanism and Early Intervention Research on Acute Lung Injury During Emergence Surgery of Acute Stanford A Aortic Dissection
Principal investigator WeiPing Cheng, master
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Beijing Anzhen Hospital.