Aortic Dissection
Conditions
Brief summary
To explore the potential prognostic effect of glucocorticoid on the postoperative aorta-related adverse events after aortic dissections patients underwent thoracic endovascular aortic repair (TEVAR), glucocorticoid (30mg/kg) will be intravenously given within 2h after TEVAR.
Detailed description
This is a prospective, open, single-center, randomized controlled trial. Number of patients: 240 patients will be included and undertaken TEVAR.About 120 patients will be given glucocorticoid within 2h after TEVAR as experimental group, and the other 120 patients will be given saline as control group. Follow-up: 1. aortic computed tomographic angiography (CTA) examination 6, 12 and 24 months after TEVAR; 2. telephone or clinical follow-up at 1, 2, 3, 6, 12 and 24 months. Primary outcome measure: aorta-related adverse events. Second outcome measure: 30-day mortality after TEVAR, success rate of endovascular repair, drug-related adverse events.
Interventions
PROCEDURETEVAR
The patients will be undertaken TEVAR
DRUGGlucocorticoids
About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group
DRUGsaline
The other 120 patients will be given saline as control group
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. age from 18 to 80, male or unpregnant female; 2. diagnosed as aortic dissection, excluding intramural hematoma and penetrating aortic ulcer; 3. complicated aortic dissection with definite indications of TEVAR; 4. voluntarily signed the informed consent form; 5. good compliance with the instructions and cooperate with follow-up.
Exclusion criteria
1. no appropriate vessel approaches; 2. patients with connective tissue diseases (such as Marfan syndrome); 3. patients with endocrine disease,such as diabetes mellitus, or undergoing hormonotherapy; 4. bad compliance with the instructions and follow-up; 5. allergic to nitinol and contrast medium; 6. estimated life expectancy is less than 24 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aorta-related adverse events | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| 30-day mortality after TEVAR | 30 days |
| Success rate of endovascular repair | 24 months |
| Drug-related adverse events | 24 months |
Contacts
Primary ContactJian Zhou, Doctor
Backup ContactLei Zhang, Doctor
Outcome results
None listed