Venous Thromboembolism Risk in Critically Ill Patients: Development and Validation of a Risk Prediction Model
试验速览
- 阶段
- 不适用
- 入组人数
- 5,400
- 试验地点
- 1
- 主要终点
- In-hospital VTE
研究概览
简要总结
Introduction: Venous thromboembolism (VTE), including both deep vein thrombosis and pulmonary embolism, is a frequent cause of morbidity and mortality. The population of critically ill patients is a heterogeneous group of patients with an overall high average risk of developing VTE. No prognostic model has been developed for estimation of this risk specifically in critically ill patients. The aim is to construct and validate a risk assessment model for predicting the risk of in-hospital VTE in critically ill patients.
Methods: In the first phase of the study we will create a prognostic model based on a derivation cohort of critically ill patients who were acutely admitted to the intensive care unit. A point-based clinical prediction model will be created using backward stepwise regression analysis from a selection of predefined candidate predictors. Model performance, discrimination and calibration will be evaluated, and the model will be internally validated by bootstrapping. In the second phase of the study, external validation will be performed in an independent cohort, and additionally model performance will be compared with performance of existing VTE risk prediction models derived from, and applied to, general medical patients.
Dissemination: This protocol will be published online. The results will be reported according to the Transparent Reporting of multivariate prediction models for Individual Prognosis Or Diagnosis (TRIPOD) statement, and submitted to a peer-reviewed journal for publication.
详细描述
OVERALL STUDY OBJECTIVES
- To develop and internally validate a risk assessment model for predicting the risk of in-hospital VTE in critically ill patients (phase 1)
- To externally validate this new model (phase 2)
- To compare the performance of this model to other VTE prediction models originally developed in the general medical patient population (phase 2)
PHASE 1: DERIVATION AND INTERNAL VALIDATION
The development and validation of a risk assessment model includes three consecutive phases of derivation, external validation and impact analysis.
In this first phase (i.e., the derivation and internal validation phase) the investigators will construct a multivariable prediction model for estimating VTE risk, and convert this model into a risk assessment score. The intention is to construct a simple score which can be used at the bedside. Subsequently, the score will be internally validated. The investigators will report their findings according to the Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) statement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Emergency admission
- •Expected stay > 24 hours
排除标准
- •Age < 18 years
- •Planned admission either after surgery or for other reasons
- •Unable to provide informed consent
结局指标
主要结局
In-hospital VTE
时间窗: Initial hospital admission
VTE will be defined as any objectively proven event occurring during initial hospital admission. No screening protocol will be used. DVT will include acute thrombosis of lower-extremity veins (iliac, femoral or popliteal), confirmed by compression ultrasonography, venography, CT, MRI, or autopsy. Pulmonary embolism will be defined as acute thrombosis within the pulmonary vasculature as shown by ventilation-perfusion scan, CT angiography, or autopsy. Upper extremity DVT or venous thrombosis in another site will be excluded from the model but included in a sensitivity analysis. All VTE events will be adjudicated by the study coordinator before the development of the prediction model.
次要结局
未报告次要终点
研究者
I.C.C. van der Horst
Associate professor
University Medical Center Groningen