Observational Study of Thrombogenic Properties in 220 Patients With Proximal Femur Fracture
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Measurements of thrombogenic properties by TEG (Maximum Amplitude) and MEA (Units) and thrombotic events in 220 patients with Hip Fracture.
研究概览
简要总结
Measurement of thrombogenic properties by TEG and MEA and observation of thrombotic events over 2 years in 220 patients with hip fracture.
详细描述
Patients with proximal femur fracture have high incidences of thrombotic events. By the two "bed-side" methods TEG (Thrombelastography) and MEA (Multiple Electrode Aggregometry), the thrombogenic properties of 220 patients with proximal femur fracture will be measured at time of hospital admission and 4 times over a period of 6 months postoperatively, and the patients will be followed in a total length of 2 years to register thrombotic events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients older than 18 years who are admitted to our hospital for orthopedic surgery of proximal femur fracture.
- •The study participants must be capable to sign/accept informed concent
排除标准
- •Patients with severe dementia or that of other causes not ar capable to give informed concent.
- •Patients with known or suspected cancer, blood diseases or bleeding disorders
- •Surgery last 6 months
- •Severe renal- (eGFR (creatinine) <30)
- •Severe hepatic failure (2x UNL for bilirubin, 3x UNL for ALAT or INR > 1,3 without anticoagulation treatment)
- •Patients that, by drug spesification or -SPC, not are eligible for postoperative thrombosis prophylaxis
结局指标
主要结局
Measurements of thrombogenic properties by TEG (Maximum Amplitude) and MEA (Units) and thrombotic events in 220 patients with Hip Fracture.
时间窗: 24 months
Thrombogenic properties measured by TEG (different measurements as "MA") and MEA (measured as "U") 6 months after operation for hip fracture and clinical thrombotic events over 24 months
次要结局
- Measurements of thrombogenic properties by TEG (Maximum amplitude) and MEA (Units)) in the 100 patients with Hip Fracture and thrombotic complications(6 months)
- Measurements of thrombogenic properties by TEG (Maximum Amplitude) and MEA (Units) in 220 patients with Hip Fracture.(6 months)