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临床试验/NCT05235178
NCT05235178已完成不适用

The Effect of the CytoSorb® Filter to Remove Anticoagulants From the Circulation During Emergency Surgery for Aortic Dissection

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年4月18日最近更新:
适应症

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

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

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Johannes Lagethon Bjørnstad

Consultant Surgeon and Associate Professor

Oslo University Hospital

研究点 (1)

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