deltatrials
Recruiting NA INTERVENTIONAL 1-arm NCT06842446

Systematic Machine Learning Algorithm for Rapid Thrombosis Detection (DVT-SMART)

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

Sponsor: Ostfold Hospital Trust

Updated 2 times since 2025 Last updated: Feb 24, 2025 Started: Jan 6, 2025 Primary completion: Jan 5, 2027 Completion: Jan 5, 2029
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Deep Vein Thrombosis, this trial is actively recruiting participants. The trial is conducted by Ostfold Hospital Trust and has accumulated 2 data snapshots since 2025. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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.

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.

Status Flow

~Mar 2025 – present · 13 months · monthly snapshotRecruiting~Jan 2026 – present · 3 months · monthly snapshotRecruiting

Change History

2 versions recorded
  1. Jan 2026 — Present [monthly]

    Recruiting NA

  2. Mar 2025 — Present [monthly]

    Recruiting NA

    First recorded

Jan 2025

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Ostfold Hospital Trust
  • Sahlgrenska University Hospital
Data source: Ostfold Hospital Trust

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations