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临床试验/NCT03863548
NCT03863548已完成不适用

French Observational Study of Complications Associated With Anticoagulants and Antiplatelet Treatment in Retina/Vitreous Surgery (CLOT Study)

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 748 人开始时间: 2019年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
748
试验地点
1
主要终点
Occurrence of intra-operative and postoperative hemorrhagic complications in retina/vitreous surgery

研究概览

简要总结

Anticoagulants and antiplatelet treatments are frequently prescribed treatments to prevent or treat thromboembolic complications and reduce morbidity and mortality related to cardiovascular risk factors. In retina/vitreous surgery, there are rare but potentially serious risks of hemmorrhagic complication resulting in irreversible loss of visual acuity. There is no clear consensus on how to proceed during the perioperative period with regard to the continuation or discontinuation of anticoagulant and antiplatelet treatments in these types of surgery. the purpose of the study is to identify complications at 1 month depending on the type of surgery with or without discontinuation of antithrombotic treatments. Practitioners are not asked to change their modus operandi. The hypothesis is that there is no excess risk of peri- or post-operative hemorrhage in retino-vitreous surgery in patients treated with antithrombotic compared to untreated patients and that therefore discontinuation of these treatments before surgery is not necessary.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • person who has expressed willingness to participate
  • person over 18 years of age
  • person with a retinal-vitreous condition requiring scheduled surgery (epi-retinal membrane surgery, vitreous traction surgery, macular hole surgery).

排除标准

  • person subject to legal protection (curatorship, guardianship)
  • person deemed mentally incompetent
  • pregnant, parturient or breastfeeding woman
  • adult unwilling or unable to consent
  • patient who has already participated in the study
  • person with a physical or mental disability that does not allow participation.
  • a person who has participated in any study of an experimental medical product within the previous 3 months
  • person who experiences any of the following during the ophthalmological examination:
  • severe or proliferating diabetic retinopathy
  • intra-vitreal hemorrhage
  • tractional retinal detachment
  • subretinal or retrohyaloidal hematoma.

研究组 & 干预措施

Continuation of antithrombotic drugs

operation carried out without stopping anticoagulants

干预措施: complication (Other)

Stop anti thrombotic drugs

operation performed with stopping the anticoagulants

干预措施: complication (Other)

结局指标

主要结局

Occurrence of intra-operative and postoperative hemorrhagic complications in retina/vitreous surgery

时间窗: Through study completion, an average of 8 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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