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RECRUITING
NCT06842446
NA

Systematic Machine Learning Algorithm for Rapid Thrombosis Detection

Sponsor: Ostfold Hospital Trust

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2025-01-06

Completion Date

2029-01-05

Last Updated

2025-02-26

Healthy Volunteers

No

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.

Locations (1)

Østfold Hospital Trust

Sarpsborg, Norway