Management of Patients on Long Term Anticoagulation Therapy Undergoing a Primary Total Hip of Knee Replacement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- a composite criteria including the occurrence of one or more bleeding complications, major thrombotic events, or reoperation for any reason
研究概览
简要总结
It is a multicenter, prospective, observational study of standard care. This study analyses the care of patients on long term effective anticoagulation therapy (ADELC) during a primary hip or knee arthroplasty.
The objectives of the study are to:
- Identify clinical practices set up for patient care
- Assess the type and the frequency of perioperative complications
- Look for factors, related to patients or treatments, associated with the occurrence of these complications.
The main objective is to estimate the risks, adjusted and not, of postoperative complications associated to a long term anticoagulation by comparing patients under anticoagulation to a control group of patients having the same interventions but who are not under anticoagulation.
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
- •Adult ≥ 18 years
- •Programmed for primary hip or knee arthroplasty.
- •Effective dose of anticoagulant drugs intake for more than 1 month with the intention to resume it after the intervention for ADELC cohort; no effective dose of anticoagulant drugs intake for the control cohort.
排除标准
- •Patient non opposition
研究组 & 干预措施
ADELC
Cohort of patients on long term anticoagulation and undergoing a primary hip or knee replacement.
干预措施: anticoagulation (Drug)
结局指标
主要结局
a composite criteria including the occurrence of one or more bleeding complications, major thrombotic events, or reoperation for any reason
时间窗: up to 3 months
次要结局
- The occurrence of a complication of grade 2 or more from Dindo and Clavien classification .(within 12 months)
- The proportion of patients who are transfused during the hospitalization(up to day 15)
- The length of hospital stay(until end of study, an expected 12 months)
研究者
Dr David BIAU
Associate Professor
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique