Evaluating the AQT90 FLEX D-dimer Test for diagnosing Venous Thromboembolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the clinical performance of the AQT90 FLEX D-dimer Test in diagnosing Venous Thromboembolism (VTE) in patients with low or moderate pretest probability. It will measure various performance metrics including sensitivity, specificity, and predictive values of the test. The study will involve patients presenting with symptoms of VTE and will exclude those with certain medical conditions or recent treatments that could affect results.

Why it matters

Who can join: the full rules

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* Subject, who has an invalid written informed consent or has withdrawn consent

Where it's running

• Viborg Regional Hospital
  Viborg, Denmark Recruiting

Study contacts

• Study coordinator: Helle Toftegaard Petersen
• Email: helle.toftegaard@radiometer.dk
• Phone: +45 29259390

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.