Hierarchy of Effects of Laboratory Markers and Their Interaction With Comorbidity Concerning Outcome and Personalized Treatment of Trauma Patients in Emergency Care and Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,300
- 试验地点
- 1
- 主要终点
- any complication after long bone fracture
研究概览
简要总结
At least ten percent of trauma patients suffer from any sort of complication. The study aims to identify a risk factor profile to early identify trauma patients at risk.
详细描述
Trauma patients suffer from a high risk of complications that ranges from soft tissue complications, surgical site infection till bone non-union. Comorbidities are often know to be associated with complications. Also certain blood markers could be identified to be an indicator.
However, certain risk factors have only been investigated in small trauma cohorts so far. This study is a prospective multi center cohort trail that aims to collect all clinical data, comorbidities, medication, blood markers in trauma patients after long bone fractures. In a 6 months and one year follow up patients with complications will be identified. Methods of machine learning will help to identify a risk factor profile for certain groups of patients with complications.
The aim of the study is to early identify patients at risk for a complication after trauma according to their blood marker, clinical, comorbidity and medication profile.
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 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute long bone fracture (humerus, ulna, radius, femur, tibia) with surgical treatment
排除标准
- •associated severe injury (ISS > 16)
- •associated traumatic brain injury
- •associated traumatic spine injury
结局指标
主要结局
any complication after long bone fracture
时间窗: 6 months, one year
number of patients that suffer from a complication after surgical treatment of a primary long bone fracture
Clavien Dindo Classification
时间窗: 6 months, one year
Clavien Dindo Classification classifies surgical complications. All patients will be classified according to Clavien Dindo after 6 months and one year.
次要结局
- Charlson Comorbidity Index (CCI)(Initially)
- number of medications(initally)
- EuroQual 5 Dimensions Questionnaire (EQ5D5L)(initially, 6 months, one year.)
- patient reported outcome measure associated with the lone bone fracture(initially, 6 months, one year.)