RecruitingNCT06749223
AQT90 FLEX D-dimer Clinical Sensitivity and Specificity
Sponsor
Radiometer Medical ApS
Enrollment
600 participants
Start Date
Apr 4, 2022
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria7
- 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- Subject, who has an invalid written informed consent or has withdrawn consent
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Interventions
DIAGNOSTIC_TESTD-dimer test
Blood sample collection for D-dimer testing
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06749223