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