VTE (Venous Thromboembolism)NCT06749223
AQT90 FLEX D-dimer Clinical Sensitivity and Specificity
An observational study of VTE (Venous Thromboembolism), run by Radiometer Medical ApS at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VTE (Venous Thromboembolism)
- What is being tested?
- D-dimer test
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Apr 2022to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients presenting with signs and symptoms of VTE and getting clinical evaluation of the pretest probability of VTE scored as low or moderate corresponding to a Well's score between 0-2 for DVT and between 0-6 for PE.
Who may be able to join
- 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
Who cannot join
- 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- Subject, who has an invalid written informed consent or has withdrawn consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Viborg Regional Hospital
Viborg, 8800
Jurgita Janukonyté, MD, PhD, +45 78 44 34 12, jurgjanu@rm.dk
About this study
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.
Read the 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.
- Conditions
- VTE (Venous Thromboembolism)
- Being tested
- D-dimer test
- Keywords
- D-dimer
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-dimer testDiagnostic test
Blood sample collection for D-dimer testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
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.
Measured: From enrollment to blood sample collection; ~1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start4 Apr 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VTE (Venous Thromboembolism)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiometer Medical ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749223
- Sponsor's protocol ID
- DC-078241
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AQT90 FLEX D-dimer Clinical Sensitivity and Specificity
- ClinicalTrials.gov ID
- NCT06749223
- Acronym / sponsor ID
- DC-078241
- Conditions
- VTE (Venous Thromboembolism)
- Keywords
- D-dimer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Radiometer Medical ApSIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients presenting with signs and symptoms of VTE and getting clinical evaluation of the pretest probability of VTE scored as low or moderate corresponding to a Well's score between 0-2 for DVT and between 0-6 for PE.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-dimer testBlood sample collection for D-dimer testing | Diagnostic test | – |
Primary outcome
Sensitivity and Specificity
Time frame: From enrollment to blood sample collection; ~1 hour
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of VTE (Venous Thromboembolism), run by Radiometer Medical ApS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helle Toftegaard Petersen (+45 29259390, helle.toftegaard@radiometer.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: From enrollment to blood sample collection; ~1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.