Systematic Machine Learning Algorithm for Rapid Thrombosis Detection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: POC D-dimer, POC ultrasound, Machine learning model.
- Who it may be relevant to
- Registry conditions: Deep Vein Thrombosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating a New Diagnostic Strategy for Suspected DVT Consisting of Point of Care D-dimer, AI-based Prediction Model and Compression Ultrasound
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test POC D-dimer
POC D-dimer will be compared to laboratory D-dimer in hospital setting and used in a machine learning model - Diagnostic test POC ultrasound
Point of care (POC) ultrasound performed by ED physicians compared to ultrasound performed by radiologist. POC ultrasound 3 point examination performed by ED physician will be compared with POC ultrasound full leg examination performed by ED physician. - Diagnostic test Machine learning model
The DSS will be compared to the usual strategy. It will also be estimated how many participants where DVT could have been excluded without ultrasound.
Primary outcome measures
- Safety of the new strategy (POC D-dimer, ML-based prediction model, POC CUS by emergency physician) [Time frame: From enrollment to the end of the primary assessment period (90 days)]
Secondary outcome measures (6)
- Evaluate the efficiency of the new strategy [Time frame: From enrollment to the end of the primary assessment period (90 days)]
- Validate the safety and efficiency of the ML-based prediction model [Time frame: From enrollment to the end of the primary assessment period (90 days)]
- Evaluate concordance between CUS performed by emergency physicians and radiologists. [Time frame: 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. [Time frame: 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. [Time frame: 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 [Time frame: 90 days after enrollment.]
Eligibility criteria
Inclusion criteria
- Patients referred to the ED due to suspicion of DVT
- Age ≥ 18 years
- Able to give informed consent
Exclusion criteria
- Ongoing use of anticoagulation for more than 72 hours
- Previous participation in the study
- Life expectancy of less than three months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Norway · 1 center
- Østfold Hospital Trust — Sarpsborg
Identifiers
NCT: NCT06842446 · 682139