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临床试验/NCT02584842
NCT02584842已完成不适用

Rivaroxaban for Thrombosis Prophylaxis in Endovenous Laser Ablation With and Without Miniphlebectomy: A Multicenter Experience

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
1
主要终点
Number of patients with a EHIT class 3 or class 4 within 6 weeks after endovenous laser ablation

研究概览

简要总结

The purpose of this study is to determine retrospectively if the application of rivaroxaban after endovenous laser ablation with and without miniphlebectomy is safe and if it lowers the risk of venous thrombosis.

详细描述

Rivaroxaban is an orally active direct factor Xa inhibitor, that is used for thrombosis prophylaxis for example in the setting of orthopaedic surgery.

In the observed situation Rivaroxaban was applied in a dosage of 10mg daily during 5 days after endovenous laser ablation.

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

入选标准

  • Patients age greater than 18 years, informed consent was given.
  • Endovenous Laser Ablation (EVLA) of the greater saphenous vein (GSV), autologous saphenous vein (ASV) and/or small saphenous vein (SSV) using 1470 nm wavelength radial laser (ELVeS, Biolitec, Austria) and postinterventional Endothermal Heat Induced Thrombosis (EHIT) prophylaxis with rivaroxaban.

排除标准

  • Patients are ineligible if they had:
  • an endovenous ablation technique other than EVLA,
  • other veins than GSV, ASV or SSV treated with EVLA (i.e. perforators),
  • postinterventional EHIT prophylaxis other than prophylactic dose of rivaroxaban or
  • informed consent was not given.

结局指标

主要结局

Number of patients with a EHIT class 3 or class 4 within 6 weeks after endovenous laser ablation

时间窗: within 6 weeks after endovenous laser ablation

次要结局

  • Number of major or clinically relevant bleedings within 6 weeks after endovenous laser ablation.(within 6 weeks after endovenous laser ablation)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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