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
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