European Registry of Type A Aortic Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,902
- 试验地点
- 20
- 主要终点
- Mortality rate
研究概览
简要总结
Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD.
详细描述
Twenty centers from eight European centers of cardiac surgery have collaborated to create a multicentre observational registry (ERTAAD), which will enroll consecutive patients who underwent surgery for acute TAAD from January 2005 to March 2021. The investigators will compare patient's comorbidities, condition at referral, surgical strategies and perioperative treatments in patients with and without early and late adverse events. The primary clinical outcome will be in-hospital mortality, late mortality and reoperations on the aorta. Secondary outcomes will be stroke, acute kidney injury, surgical site infection, reoperation for bleeding, transfusion of blood products and length of stay in the intensive care unit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta;
- •Patients aged > 18 years:
- •Symptoms started within 7 days from surgery;
- •Primary surgical repair of acute type A aortic dissection;
- •Any other major cardiac surgical procedure concomitant with surgery for type A aortic dissection.
排除标准
- •Patients aged < 18 years;
- •Onset of symptoms > 7 days from surgery;
- •Prior procedure for type A aortic dissection;
- •Retrograde type A aortic dissection (with primary tear located in the descending aorta);
- •Concomitant endocarditis;
- •Type A aortic dissection secondary to blunt or penetrating chest trauma.
结局指标
主要结局
Mortality rate
时间窗: During the index hospital stay until last follow-up control
All-cause mortality
Cumulative incidence of reoperation on the aorta
时间窗: During the index hospital stay until last follow-up control
Any surgical and endovascular procedure on any segment of the aorta for aortic dissection or its related complication
次要结局
- Incidence and amount of blood transfusion(From date of procedure until the date of hospital discharge, assessed up to 3 months)
- Incidence of stroke(From date of procedure until the date of hospital discharge, assessed up to 3 months)
- Incidence of reoperation for bleeding(From date of procedure until the date of hospital discharge, assessed up to 3 months)
- Incidence of acute kidney injury(From date of procedure until the date of hospital discharge, assessed up to 3 months)
- Length of stay in the intensive care unit(From date of procedure until the date of hospital discharge, assessed up to 3 months)
- Incidence of paraplegia/paraparesis(From date of procedure until the date of hospital discharge, assessed up to 3 months)
- Incidence of surgical site infection(From date of procedure until the date of hospital discharge, assessed up to 3 months)
- Incidence of global brain ischemia(From date of procedure until the date of hospital discharge, assessed up to 3 months)
研究者
Fausto Biancari
Professor
Helsinki University Central Hospital