NCT04007484Unknown不适用
The Effects of Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Cardiopulmonary Bypass and Deep Hypothermic Circulatory Arrest: A Randomized, Controlled, Double-blinded Trial
The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2019年1月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Composite major complications
研究概览
简要总结
This study is a single-center, randomized, controlled, double-blind clinical trial. The main purpose of this study is to evaluate if hemoperfusion is sufficient to improve the prognosis of acute type A aortic dissection patients undergoing cardiopulmonary bypass and deep hypothermia circulatory arrest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 yr-75yr, regardless of gender
- •Patients with Acute type A aortic dissection and arch involvement (onset time ≤ 7 days)
- •Able to understand and sign the informed consent
排除标准
- •Unable to understand and sign the informed consent
- •Active hemorrhage or thrombocytopenic purpura
- •Previous history of liver diseasess, renal insufficiency or cerebrovascular diseases
- •Preoperative organ malperfusion
- •Previous history of cardiac surgeries
- •Oral anticoagulant or antiplatelet drugs within one week of disease onset
- •Hereditary connective tissue diseases such as Marfan syndrome, Ehlers-Danlos and Loeys-Dietz syndrome
结局指标
主要结局
Composite major complications
时间窗: up to 30 days
Operative mortality, Secondary thoracotomy, New onset of postoperative renal failure requiring dialysis, Paraplegia, Stroke/cerebrovascular accidents, Low cardiac output syndrome, Reintubation, Severe liver dysfunction, ECMO support, Multiple organ dysfunction syndrome (MODS)
次要结局
- Changes in the plasma levels of other inflammatory factors such as interleukin (IL)-6, IL-8, IL-10, IL-1β and TNF-α(up to 3 days)
- Changes of plasma MIF levels during the perioperative period(up to 3 days)
- Changes of plasma CRP levels during the perioperative period(up to 3 days)
- Total drainage within the first 24 hours of surgery(24 hours)
- Incidence of postoperative acute kidney injury(up to 30 days)
- Changes of the plasma APTT, PT, FIB, FDP and DDi levels during the perioperative period(up to 3 days)
- Incidence of postoperative respiratory failure(up to 30 days)
- Incidence of postoperative delirium(up to 30 days)
- Incidence of postoperative liver injury(up to 30 days)
- Incidence of postoperative myocardial infarction(up to 30 days)
- Changes of the plasma II, VII, IX, X, XI and XII levels during the perioperative period(up to 2 days)
研究者
研究点 (1)
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