The Effect of the CytoSorb® Filter to Remove Anticoagulants From the Circulation During Emergency Surgery for Aortic Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in apixaban concentration after 60 minutes of hemadsorption
研究概览
简要总结
The direct oral anticoagulants (DOACs) and particularly the FXa inhibitors are a concern in patients presenting with type A aortic dissection as this may contribute to severe bleeding complications. The antidote andexanet alfa (Ondexxya®) can interact with the heparin- anti-thrombin III (ATIII) complex which may neutralize the anticoagulant effect of heparin and the use of andexanet alfa before surgery necessitating heparin-anticoagulation has been reported to cause unresponsiveness to heparin. The investigators have preliminary in-vitro data demonstrating the ability to remove apixaban from reconstituted blod by hemadsorption and are now analyzing if aFXa inhibitor levels may be reduced by hemadsorption in the clinical setting analyzing this in patients using FXa inhibitors being operated acutely for type A aortic dissection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for urgent surgery for proximal aortic disease
- •Treatment with FXa inhibitor for more than 2 weeks
- •Measured concentration of FXa inhibitor in therapeutic range (>50 ng/mL) at the time of admission.
- •Intraoperative use of Cytosorb® hemadsorber.
排除标准
- •Low FXa inhibitor concentration (<50 ng/mL) at the time of admission
结局指标
主要结局
Change in apixaban concentration after 60 minutes of hemadsorption
时间窗: 60 minutes
Apixaban concentration will be analysed by ultraperformance liquid chromatography mass spectrometry (UPLC-MS) from blood samples at different time-points (0, 5, 10, 30, 60, 120 minutes) during hemadsorption.
次要结局
- Change in apixaban concentration during hemadsorption(5-120 minutes)
- Apixaban concentration follwing hemadsorption(24 hours)
研究者
Johannes Lagethon Bjørnstad
Consultant Surgeon and Associate Professor
Oslo University Hospital
