Evaluating a New Diagnostic Strategy for Suspected DVT Consisting of Point of Care D-dimer, AI-based Prediction Model and Compression Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Safety of the new strategy (POC D-dimer, ML-based prediction model, POC CUS by emergency physician)
研究概览
简要总结
The goal of this clinical trial is to compare the use of a machine learning-based algorithm and point-of-care D-dimer to laboratory D-dimer and compression ultrasound to exclude deep vein thrombosis in the under extremities in patients referred to a medical department suspected of having deep vein thrombosis. The main aim is to answer are if a machine learning algorithm and point of care D-dimer can exclude deep vein thrombosis in more patients than clinical assessment and D-dimer alone.
详细描述
All participants will follow the usual diagnostic algorithm used for patients with suspected DVT referred to Ostfold Hospital (all patients are examined by a physician, D-dimer is analyzed in all patients, ultrasound is performed by a radiologist in patients with positive D-dimer). In addition to usual care, POC D-dimer, POC ultrasound (performed by ED physicians), blood sampling for biobanking, and photographies of the under extremities will be performed. The machine learning model will be tested to see if the prediction is correct. In participants where ultrasound is performed, it will also be assessed whether the machine learning algorithm could have excluded the participant without the use of ultrasound. None of the additional procedures will have any impact on the patient diagnostics or treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 referred to the ED due to suspicion of DVT
- •Age ≥ 18 years
- •Able to give informed consent
排除标准
- •Ongoing use of anticoagulation for more than 72 hours
- •Previous participation in the study
- •Life expectancy of less than three months.
研究组 & 干预措施
All participants
All participants will be treated the same way.
干预措施: POC D-dimer (Diagnostic Test)
All participants
All participants will be treated the same way.
干预措施: POC ultrasound (Diagnostic Test)
All participants
All participants will be treated the same way.
干预措施: Machine learning model (Diagnostic Test)
结局指标
主要结局
Safety of the new strategy (POC D-dimer, ML-based prediction model, POC CUS by emergency physician)
时间窗: From enrollment to the end of the primary assessment period (90 days)
Evaluate the safety of a new strategy consisting of POC D-dimer and an ML-based prediction model followed by CUS performed by emergency physicians by comparing the new strategy's safety with our standard care by measuring the proportion of patients in whom DVT is excluded according to the new strategy but was diagnosed with DVT by standard care or in whom DVT is diagnosed within the 90-day follow up.
次要结局
- Evaluate the efficiency of the new strategy(From enrollment to the end of the primary assessment period (90 days))
- Validate the safety and efficiency of the ML-based prediction model(From enrollment to the end of the primary assessment period (90 days))
- Evaluate concordance between CUS performed by emergency physicians and radiologists.(From time of enrollment until time of ultrasound examination performed by radiologist, assessed up to 48 hours.)
- Evaluate concordance between POC D-dimers in an ED setting and laboratory D-dimers.(From enrollment to the completion of D-dimer analysis, assessed up to 24 hours.)
- Evaluate the hypothetical time to be completed for the novel strategy compared to the standard strategy.(From time of enrollment until time of discharge from the emergency department either discharged from the hospital or hospitalized, assessed up to 24 hours.)
- Evaluate the safety of a limited ultrasound protocol (two-point and proximal) compared to full-leg CUS performed by emergency physicians and radiologists(90 days after enrollment.)