跳至主要内容
临床试验/EUCTR2018-000753-45-ES
EUCTR2018-000753-45-ES进行中(未招募)1 期

Vitreretinal surgery with and without oral anticoagulants: surgical complications, visual results and perioperative thromboembolic events.

AVARRBIOMED-FUNDACION MIGUEL SERVET0 个研究点目标入组 96 人开始时间: 2018年6月20日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
96

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Adults (over 18 years) of both sexes.
  • 2. Clinical indication for vitrectomy alone or associated with facoemulsification or scleral buckling.
  • 3. Under treatment with any of the following oral anticoagulants: acenocumarol, dabigatran, rivaroxaban, apixaban or edoxaban.
  • 4. Able to give informed consent for vitreoretinal surgery and to participate in the trial.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 46

排除标准

  • 1. Patients unable to be operated under retrobulbar anesthesia.
  • 2. Patients on antiplatelet therapy except if the antiaggregation is with acetylsalicylic acid.
  • 3. Patients who have recently started oral anticoagulation (less than 1 month before screening).
  • 4. Any medical, psychological, psychiatric, geographic or social situation that could interfere with the participation of the patient in the trial or with the follow-up and adherence with the protocol and the evaluation of the results of the present trial.

研究者

发起方
AVARRBIOMED-FUNDACION MIGUEL SERVET

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