EUCTR2014-000388-41-NL进行中（未招募）1 期
Does oral administration of dabigatran etexilate, a direct thrombin inhibitor, achieve clinical significant concentrations of dabigatran and thrombin inhibiting activity in vitreous and subretinal fluid? - Dabigatran & Ocular Accessibility
The Rotterdam Eye Hospital0 个研究点目标入组 28 人开始时间: 2014年3月13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
- 28
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
- •- Age = 18 years,
- •- Informed consent,
- •- Needing surgery for a rhegmatogenous retinal detachment (scleral buckle surgery or vitrectomy)
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •-Using other anticoagulants (e.g. acenocoumarol, heparin etc),
- •-Using medication that increases risk of GI bleeding (e.g. aspirin, NSAID’s, SSRI’s, oral corticosteroids).
- •-History of stomach ulcer/ bleeding
- •-Patients with renal function (CrCL) < 50 mL/min,
- •-Age > 75
- •-Hepatic impairment,
- •-Hypersensitivity to the active substance or to any of the excipients,
- •-Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole, tacrolimus and dronedarone,
- •-Lesion or condition at significant risk of major bleeding.
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