AQT90 FLEX D-dimer Clinical Sensitivity and Specificity

Last updated: February 13, 2025
Sponsor: Radiometer Medical ApS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Venous Thromboembolism

Thromboembolism

Venous Thrombosis

Treatment

D-dimer test

Clinical Study ID

NCT06749223
DC-078241
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Subject is 18 years of age and older

  • Subject, who presents with signs and symptoms of VTE and had low or moderatepre-test probability of DVT or PE assessed by Well's score

  • Subject must be able to understand information given, and be willing and able tovoluntarily give their consent to participate in this study

Exclusion

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  • Subject, who has an invalid written informed consent or has withdrawn consent

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: D-dimer test
Phase:
Study Start date:
April 04, 2022
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Viborg Regional Hospital

    Viborg, 8800
    Denmark

    Active - Recruiting

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