Actively Recruiting

Age: 18Years +
All Genders
ID06749223

AQT90 FLEX D-dimer Clinical Sensitivity and Specificity for Diagnosing Venous Thromboembolism

Led by Radiometer Medical ApS · Updated on 2025-02-17

600

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the clinical performance of the AQT90 FLEX D-dimer Test to help diagnose Venous Thromboembolism (VTE) in patients who show signs and symptoms of VTE and have a low or moderate pre-test probability based on the Well's score. The study aims to determine how well the test can detect VTE by measuring its sensitivity, specificity, and predictive values. The study involves collecting blood samples from participants for D-dimer testing using the AQT90 FLEX device. This observational study does not involve any treatment but focuses on assessing the test's diagnostic accuracy within about one hour after enrollment and sample collection. Participants will be assessed for eligibility and provide informed consent before enrollment. Researchers will analyze blood samples to measure the test's sensitivity and specificity in diagnosing VTE. The study includes monitoring participants during the brief evaluation period, with no long-term treatment or follow-up required. Total participation time corresponds to enrollment and quick blood sample collection.

CONDITIONS

Brief Title

AQT90 FLEX D-dimer Clinical Sensitivity and Specificity

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject is 18 years of age and older
  • Subject presents with signs and symptoms of venous thromboembolism (VTE) and has low or moderate pre-test probability of deep vein thrombosis (DVT) or pulmonary embolism (PE) assessed by Well's score
  • Subject can understand the information given and is willing and able to voluntarily give consent to participate in this study
Not Eligible

You will not qualify if you...

  • Subject is pregnant
  • Subject has received fibrinolytic therapy within the previous seven days
  • Subject has received anticoagulant treatment (unfractionated heparin, LMWH, vitamin K-antagonists, direct oral anticoagulants) within the previous seven days
  • Subject has had trauma or surgery within the previous four weeks
  • Subject has malignancy
  • Subject has disseminated intravascular coagulation (DIC)
  • Subject has invalid written informed consent or has withdrawn consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 1 hour

Participants undergo blood sample collection for D-dimer testing to aid in the diagnosis of venous thromboembolism.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Viborg Regional Hospital

Viborg, Denmark, 8800

Actively Recruiting

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Research Team

H

Helle Toftegaard Petersen

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Frequently Asked Questions

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