AQT90 FLEX D-dimer Clinical Sensitivity and Specificity
ConditionVTE (Venous Thromboembolism)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRadiometer Medical ApS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
D-dimer test
Diagnostic testBlood sample collection for D-dimer testing
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 hourSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov