VTE (Venous Thromboembolism)
Conditions
Keywords
D-dimer
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTD-dimer test
Blood sample collection for D-dimer testing
Sponsors
Radiometer Medical ApS
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is 18 years of age and older * Subject, who presents with signs and symptoms of VTE and had low or moderate pre-test probability of DVT or PE assessed by Well's score * Subject must be able to understand information given, and be willing and able to voluntarily give their consent to participate in this study
Exclusion criteria
* Subject, who is pregnant * Subject, who has received fibrinolytic therapy within the previous seven days * Subject, who has received treatment with anticoagulants (unfractionated heparin, LMWH, VKA (vitamin K-antagonists), DOACs (direct oral anticoagulants) within the previous seven days * Subject, who has had trauma or surgery within the previous four weeks * Subject with malignancy * Subject with disseminated intravascular coagulation (DIC) * Subject, who has an invalid written informed consent or has withdrawn consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity | From enrollment to blood sample collection; ~1 hour | 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. |
Countries
Denmark
Contacts
Primary ContactHelle Toftegaard Petersen
Outcome results
None listed