NCT06842446

Systematic Machine Learning Algorithm for Rapid Thrombosis Detection

Evaluating a New Diagnostic Strategy for Suspected DVT Consisting of Point of Care D-dimer, AI-based Prediction Model and Compression Ultrasound

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Ostfold Hospital Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Deep Vein Thrombosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-06
• Primary completion: 2027-01-05
• Completion: 2029-01-05
• First posted: 2025-02-24
• Last updated: 2025-02-26

Locations

1 site across 1 country: Norway