NCT03231787已完成不适用
Randomized Parallel Multicenter Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery (AFFEcT Study)
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau3 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2017年9月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 3
- 主要终点
- Time from emergency admission to surgery
研究概览
简要总结
National, randomized, open, parallel, multicenter clinical trial of two comparison groups that will evaluate the feasibility of a strategy based on a diagnostic test to shorten the surgery time in antiaggregated patients with proximal femur fracture.
The experimental group will undergo surgery as soon as platelet aggregability, according to the PLATELETWORKS® method is correct within 24-48 hours.
The control group will undergo surgery according to the usual practice of the center taking into account the safety time of the antiplatelet agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Patients older than 18 years
- •Patients of both sexes
- •Patients with a proximal femoral fracture requiring surgery
- •Patients receiving antiplatelet agents at the time of admission to the emergency room: AAS> 100 mg / d (Aspirin®), Trifusal> 300 mg / d (Digren®; Edigen®), clopidogrel (Plavix®), prasugrel ®), ticagrelor (Brilique ®) and ticlopidine (Tiklid ®).
- •Patients who give their signed consent
排除标准
- •Multiple fractures
- •Pathological fractures
- •Patients receiving vitamin K antagonist oral anticoagulants (warfarin and acenocoumarol) or new oral anticoagulants (apixaban, rivaroxaban and dabigatran) or who have acquired congenital or acquired coagulopathy
- •Patients with AAS ≤100mg, trifusal ≤300mg
- •Patients who do not give their informed consent or their legal guardian
结局指标
主要结局
Time from emergency admission to surgery
时间窗: Up to 120 hours
Time from emergency admission to surgery will be measured in hours
次要结局
- Postoperative hemoglobin(From 12 hours after surgery until date of discharge, an average of 5 days)
- Platelet Functionality(From date of admission until the day before surgery, an average of 2 days)
- Quality of life(Preoperative, 5 days after surgery, and 1, 6 and 12 months after surgery)
- Bleeding(Through hospitalization, an average of 5 days)
- Preoperative hemoglobin(12 hours before surgery)
- Need for blood transfusion(Through hospitalization, an average of 5 days)
- Medical complications(1 week and 30 days after surgery)
- Time to admission to patient movilization(From date of admission until the date of first movilization, an average of 3 days)
- Mortality(1 year)
- Cost effectiveness ratio(1 year)
- Surgical wound complications(1 week and 30 days after surgery)
研究者
研究点 (3)
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