Systematic Machine Learning Algorithm for Rapid Thrombosis Detection
NCT06842446 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000
Last updated 2025-02-26
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.
Conditions
- Deep Vein Thrombosis
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.
Sponsors & Collaborators
-
Sahlgrenska University Hospital
collaborator OTHER -
Ostfold Hospital Trust
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-06
- Primary Completion
- 2027-01-05
- Completion
- 2029-01-05
Countries
- Norway
Study Locations
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