Biomarkers of Rhabdomyolysis in the Diagnosis of Acute Compartment Syndrome: Study Protocol of a Prospective Multinational, Multicentre Study in Patients With Tibial Fractures.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Peak levels of P-myoglobin and P-creatine phosphokinase
研究概览
简要总结
This prospective multinational, multicentre cohort study aims to investigate the hypothesis that biomarkers of muscle cell damage can predict acute compartment syndrome in patients with tibial fractures.
详细描述
Patients with a tibial fracture are included. P-myoglobin and P-creatine phosphokinase are analysed at 6-hourly intervals pre- and if applicable, postoperatively after surgical fixation or fasciotomy. Also, blood samples will be collected in 6 hourly intervals if acute compartment syndrome is suspected. An expert panel of senior orthopaedic surgeons will retrospectively assess study data and classify patients who had undergone fasciotomy into those with and without acute compartment syndrome.
Blood samples will also be collected in patients with acute compartment syndrome without tibial fractures, to serve as a positive control group.
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic tibial fracture
排除标准
- •Malignancy
- •Acute myocardial infarction
- •Kidney failure (GFR ≤35 ml/min)
- •Muscle disease
- •Paraplegia/tetraplegia
- •Non-fracture group
- •Inclusion Criteria:
- •Suspected acute compartment syndrome
- •Exclusion Criteria:
- •Malignancy
- •Acute myocardial infarction
- •Kidney failure (GFR ≤35 ml/min)
- •Muscle disease
- •Paraplegia/tetraplegia
- •Associated fracture
- •Acute vascular event
结局指标
主要结局
Peak levels of P-myoglobin and P-creatine phosphokinase
时间窗: Up to 5 days
A series of blood samples will be collected with 6-hourly interval at the following time-points: * Admission to hospital: P-myoglobin and P-creatine phosphokinase are collected at 6-hourly intervals for a maximum of 48 hours or until definitive surgical fixation of the fracture is performed (temporary external fixation excluded). * Surgical fracture treatment: After surgical intervention (definitive surgical fracture treatment, excluding temporary external fixation), another series of blood samples is collected with 6-hourly interval for 24 hours. Acute compartment syndrome: If suspicion of acute compartment syndrome emerges, blood samples will be collected with 6-hourly interval until fasciotomy is performed or the suspicion is written off. After fasciotomy, blood samples will be continued with 6-hourly interval for 24 hours.
次要结局
- Histological evidence of muscle damage(At internal fixation and/or fasciotomy)
- MicroRNA(Up to 5 days)
研究者
Jörg Schilcher
Associate professor
University Hospital, Linkoeping