An observational study in VTE (Venous Thromboembolism), sponsored by Radiometer Medical ApS. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Radiometer Medical ApS (part of Danaher Corporation) · Observational
The goal of this study is evaluate the clinical performance of the AQT90 FLEX D-dimer Test as an aid in the diagnosis of Venous Thromboembolism.
The objective is to evaluate the clinical performance of the AQT90 FLEX D-dimer Test as an aid in the diagnosis of VTE in patients presenting with low or moderate pretest probability (PTP), by determining the clinical sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), positive likelihood ratio (LR+) and negative likelihood ratio (LR-) of the assay.
712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.
This study's planned enrollment of 600 is below the median of 700 across 282 observational studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →Radiometer Medical ApS is the lead sponsor of 19 studies on the registry; 5 are open to participants now.
First submitted after Radiometer Medical ApS became part of Danaher Corporation.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adult patients presenting with signs and symptoms of VTE and getting clinical evaluation of the pretest probability of VTE scored as low or moderate corresponding to a Well's score between 0-2 for DVT and between 0-6 for PE.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Blood sample collection for D-dimer testing
Sensitivity and Specificity
Clinical performance (clinical sensitivity, clinical specificity, Negative Predictive Values (NPV), Positive Predictive Values (PPV), Positive Likelihood Ratio (LR+), Negative Likelihood Ratio (LR-) and 95 % confidence intervals) for the AQT90 FLEX D-dimer assay against the hospital diagnosis.
Time frame: From enrollment to blood sample collection; ~1 hour
Plan to share: No
No publications or documents are linked to this record.
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