An interventional study of POC D-dimer and POC ultrasound in Deep Vein Thrombosis, sponsored by Ostfold Hospital Trust. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Ostfold Hospital Trust · Not applicable, Interventional, and Diagnostic
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.
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.
785 studies on the registry are indexed under Venous Thrombosis; 110 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 152 across 477 interventional studies indexed under Venous Thrombosis.
Browse Venous Thrombosis studies →Ostfold Hospital Trust is the lead sponsor of 50 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will be treated the same way.
Diagnostic Test: POC D-dimer · Diagnostic Test: POC ultrasound · Diagnostic Test: Machine learning model
POC D-dimer will be compared to laboratory D-dimer in hospital setting and used in a machine learning model
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.
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.
Also known as: Decision support system
Safety of the new strategy (POC D-dimer, ML-based prediction model, POC CUS by emergency physician)
Evaluate the safety of a new strategy consisting of POC D-dimer and an ML-based prediction model followed by CUS performed by emergency physicians by comparing the new strategy's safety with our standard care by measuring the proportion of patients in whom DVT is excluded according to the new strategy but was diagnosed with DVT by standard care or in whom DVT is diagnosed within the 90-day follow up.
Time frame: From enrollment to the end of the primary assessment period (90 days)
Evaluate the efficiency of the new strategy
The proportion of patients in whom DVT can be ruled out by the ML-based prediction model with POC D-dimer compared to the efficiency of Wells score and laboratory D-dimer
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
Safety will be determined by the proportion of patients in whom DVT is excluded by the ML-model but diagnosed by standard care. Efficiency will be determined by the proportion of patients in whom DVT can be excluded by the ML-based 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.
Determine the proportion of false negative and false positive diagnosis of DVT in emergency physician-performed ultrasound compared with ultrasound performed by 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.
Compare the two POC D-dimers with the STA-Liatest D-dimer and Siemens INNOVANCE by direct comparison of the true/false positive/negative results.
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.
Estimating the total management time defined as time from ED registration to ED discharge in patients evaluated according to the new strategy compared to standard care.
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
Estimating the proportion of patients in whom DVT was ruled out by the limited ultrasound protocol but was diagnosed with DVT by the whole-leg ultrasound.
Time frame: 90 days after enrollment.
Plan to share: Undecided — The plan to share IPD with other researchers are not yet decided because it has not yet been discussed.
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Apr 2027, 26 months after the start.
Of 99 non-industry interventional studies with no phase under Venous Thrombosis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 57. This study's planned 26 months is below that.
Counting every sponsor, half of 117 studies reached it within 34 months; a quarter within 13 and three quarters within 56.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Jan 2027 → Apr 2027 and completion Jan 2029 → Apr 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Ostfold Hospital Trust