AQT90 FLEX D-dimer Clinical Sensitivity and Specificity

Recruiting

• Conditions: VTE (Venous Thromboembolism)

• Registration Number: NCT06749223
• Lead Sponsor: Radiometer Medical ApS

Brief 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.

Detailed Description

The objective is to evaluate the clinical performance of the AQT90 FLEX D-dimer Test as an aid in the diagnosis of VTE in patients presenting with low or moderate pretest probability (PTP), by determining the clinical sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), positive likelihood ratio (LR+) and negative likelihood ratio (LR-) of the assay.

Study Timeline

• Study Start: 2022-04-04
• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

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• Subject, who has an invalid written informed consent or has withdrawn consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity	3 years	Clinical performance (clinical sensitivity, clinical specificity, Negative Predictive Values (NPV), Positive Predictive Values (PPV), Positive Likelihood Ratio (LR+), Negative Likelihood Ratio (LR-) and 95 % confidence intervals) for the AQT90 FLEX D-dimer assay against the hospital diagnosis.

Trial Locations

Locations (1)

Viborg Regional Hospital; 🇩🇰 Viborg, Denmark