Evaluating the AQT90 FLEX D-dimer Test for diagnosing Venous Thromboembolism
AQT90 FLEX D-dimer Clinical Sensitivity and Specificity
This study is testing the AQT90 FLEX D-dimer Test to see if it can help diagnose Venous Thromboembolism in patients who might have a low or moderate chance of having the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radiometer Medical ApS Industry-sponsored |
| Locations | 1 site (Viborg) |
| Trial ID | NCT06749223 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who show signs of VTE with low or moderate pretest probability.
Not a fit: Patients who are pregnant, have received recent anticoagulant therapy, or have certain medical conditions like malignancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of VTE diagnoses, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promising results with similar D-dimer testing approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Viborg
- Viborg Regional Hospital — Viborg, Denmark (Recruiting)
Study contacts
- Study coordinator: Helle Toftegaard Petersen
- Email: helle.toftegaard@radiometer.dk
- Phone: +45 29259390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.