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New fingerstick test for blood thinner monitoring put to the test

NCT ID NCT03682419

Diagnosis Sponsor: LumiraDx UK Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested how well a small, portable device (LumiraDx) measures blood clotting (INR) compared to standard lab tests. Researchers collected blood from 420 adults, some taking warfarin and some not, using both a fingerstick and a vein draw. The goal was to see if the device is accurate enough for use in clinics, potentially making it easier to monitor patients on blood thinners.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide a faster, easier way to monitor blood clotting in clinics, helping manage medications like warfarin more conveniently.
What could go wrong
This is a completed device accuracy study, not a treatment trial. It does not test any new therapy or health outcome, so its impact is limited to improving monitoring, not curing disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

420 people

The number who actually took part.

Started

Sep 2018

Finished

Nov 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Capillary and venous whole blood samples were collected and analyzed from adult males and females who are receiving current vitamin K antagonist therapy and fulfil all other study inclusion and exclusion criteria. A subsection of the subject population (\~50 subjects) consisted of adult males and females who fulfil all other study inclusion criteria but are not in receipt of vitamin K antagonist therapy. This was done in order to test the lower measurement range of the LumiraDx Instrument.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria - VKA Therapy Subjects: * Persons \>18 years of age * Willing and able to provide written informed consent and comply with study procedures * Currently prescribed vitamin K antagonist therapy * Deemed medically appropriate for study participation by the Investigator Exclusion Criteria - VKA Therapy Subjects: * Persons \<18 years of age * Subject has previously participated in this study * Subject is within 4 weeks of first prescription of vitamin K antagonist therapy * Confirmed or suspected pregnancy * Unwilling or unable to provide written informed consent and comply with study procedures * Vulnerable populations deemed inappropriate for study by the Investigator * Deemed medically inappropriate for study by the Investigator (i.e. patients with a known inherited \[e.g. haemophilia or von Willebrand's disease\] or acquired \[e.g. liver cirrhosis\] condition likely to be associated with a coagulopathy; or patients receiving non-VKA anticoagulant medications) Inclusion Criteria - Non-VKA Therapy Subjects: * Persons \>18 years of age * Willing and able to provide written informed consent and comply with study procedures * Deemed medically appropriate for study participation by the Investigator Exclusion Criteria - Non-VKA Therapy Subjects: * Persons \<18 years of age * Subject has previously participated in this study * Confirmed or suspected pregnancy * Unwilling or unable to provide written informed consent and comply with study procedures * Vulnerable populations deemed inappropriate for study by the Investigator * Any persons deemed medically inappropriate for study by the Investigator

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Conditions

The condition(s) this trial relates to.

antiphospholipid syndrome atrial fibrillation Donath-Landsteiner hemolytic anemia Dressler syndrome pulmonary embolism thrombophilia venous thromboembolism Venous Thrombosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antiphospholipid syndrome Artificial heart device user Atrial fibrillation Deep vein thrombosis Post-myocardial infarction syndrome Pulmonary embolism Thrombophilia

Contacts and locations

Locations

  • Glasgow Royal Infirmary Clinical Research Facility

    Glasgow, G4 0SF, United Kingdom

  • Golden Jubilee National Hospital

    Glasgow, G81 4DY, United Kingdom

  • Wishaw General Hospital, NHS Lanarkshire

    Wishaw, ML2 0DP, United Kingdom

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