AQT90 FLEX D-dimer Clinical Sensitivity and Specificity

Recruiting now

Conditions studied: VTE (Venous Thromboembolism)

In brief

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.

Key facts

Study ID

NCT06749223

Run by

Radiometer Medical ApS

People needed

600

Starts

2022-04-04

Expected to finish

2025-06-30

Last updated by the study team

2025-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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• Subject, who has an invalid written informed consent or has withdrawn consent

Where it is running

• Viborg Regional Hospital — Viborg, Denmark (enrolling)

Full record on ClinicalTrials.gov

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