Prognostic Value of Single-dose Glucocorticoid After Endovascular Repair for Aortic Dissection
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 主要终点
- Aorta-related adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 18 to 80, male or unpregnant female;
- •diagnosed as aortic dissection, excluding intramural hematoma and penetrating aortic ulcer;
- •complicated aortic dissection with definite indications of TEVAR;
- •voluntarily signed the informed consent form;
- •good compliance with the instructions and cooperate with follow-up.
排除标准
- •no appropriate vessel approaches;
- •patients with connective tissue diseases (such as Marfan syndrome);
- •patients with endocrine disease,such as diabetes mellitus, or undergoing hormonotherapy;
- •bad compliance with the instructions and follow-up;
- •allergic to nitinol and contrast medium;
- •estimated life expectancy is less than 24 months.
研究组 & 干预措施
TEVAR+GC
The patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR
干预措施: TEVAR (Procedure)
TEVAR+GC
The patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR
干预措施: Glucocorticoids (Drug)
TEVAR+Vehicle
The patients underwent TEVAR. Then saline will be given after TEVAR
干预措施: TEVAR (Procedure)
TEVAR+Vehicle
The patients underwent TEVAR. Then saline will be given after TEVAR
干预措施: saline (Drug)
结局指标
主要结局
Aorta-related adverse events
时间窗: 24 months
次要结局
- 30-day mortality after TEVAR(30 days)
- Success rate of endovascular repair(24 months)
- Drug-related adverse events(24 months)
研究者
Zaiping JING
Director of Vascular Surgery Department
Changhai Hospital