AQT90 FLEX D-dimer Clinical Sensitivity and Specificity

Launched by RADIOMETER MEDICAL APS · Dec 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the AQT90 FLEX D-dimer Test, which is a blood test designed to help doctors determine if a patient has a condition called Venous Thromboembolism (VTE). VTE includes serious issues like deep vein thrombosis (DVT) and pulmonary embolism (PE), which can occur when blood clots form in the veins. The goal of the study is to see how well this test can identify patients who might have VTE, particularly those who show early signs but have a lower chance of having the condition based on certain scoring methods.

To participate in this study, individuals must be at least 18 years old and show symptoms of VTE, but their initial risk should be considered low or moderate according to a specific scoring system. Participants should be able to understand the study information and agree to take part willingly. Those who are pregnant, have had certain recent treatments, or have specific health conditions may not be eligible. If you choose to participate, you can expect to undergo the D-dimer test, and you will be contributing to important research that could help improve the diagnosis of VTE in the future.

Gender

ALL

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• • Subject, who has an invalid written informed consent or has withdrawn consent