Anticoagulants and Bleeding DisordersVKA_GERMANYNCT04074980
Evaluating LumiraDx INR Test Accuracy in Patients Taking Phenprocoumon Anticoagulant.
An observational study of Anticoagulants and Bleeding Disorders, run by LumiraDx UK Limited at 1 site in Germany.
Trial summary
This study is to evaluate the INR levels in patients taking phenprocoumon using the LumiraDx Point of Care INR test and comparing the results to the laboratory reference method , the ACL Elite Pro. Comparison will also be made with the Roche Coaguchek point of care INR test (point of care reference method). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulants and Bleeding Disorders
- What is being tested?
- Venous and Fingerstick blood draws and Venous blood draw
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- 9 May 2019to 15 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 102 subjects (24 female and 78 male) taking Phenprocoumon. Ages ranged from 36 - 88 years.
Who may be able to join
- Persons >18 years of age
- Willing and able to provide written informed consent and comply with study procedures
- Currently prescribed Phenprocoumon VKA Therapy
- Deemed medically appropriate for study participation by the Investigator
Who cannot join
- Subject has previously participated in this part of the study
- Subject is within 4 weeks of first prescription of Phenprocoumon
- Subject is taking a DOAC, or non-Phenprocoumon VKA therapy
- Confirmed or suspected pregnancy
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
CLINICAL SITE Klinik am See, Rehabilitation Clinic for Cardiovascular Diseases, Ruedersdorf/Berlin.
Rüdersdorf
About this study
Official title: Post CE Study: Evaluation of the Accuracy of INR Results From Patients Taking Phenprocoumon as Anticoagulant When Measured Using the Lumiradx INR Test
This study is to evaluate the INR levels in patients taking phenprocoumon using the LumiraDx Point of Care INR test and comparing the results to the laboratory reference method , the ACL Elite Pro. Comparison will also be made with the Roche Coaguchek point of care INR test (point of care reference method). Performance will be demonstrated across a subject population of adult males and females in receipt of Phenprocoumon VKA therapy. This population is representative of the indications for use of the CE marked product. Operators will be trained clinical site staff. Venous plasma and capillary whole blood samples will be obtained from each subject in order to assess accuracy of the the LumiraDx Platform when compared to the reference devices (ACL Elite and Coaguchek Pro).
Read the detailed description
Vitamin K antagonists (VKA) are a group of substances that reduce blood clotting by reducing the action of vitamin K. They are used in anticoagulant medications in the prevention of thrombosis. The drugs work by depleting the active form of the vitamin by inhibiting Vitamin K epoxide reductase and thus the recycling of inactive vitamin K back to the active reduced form. The most widely prescribed VKAs are Coumarins. This group is composed of several different structurally similar molecules and includes warfarin (Coumadin), acenocoumerol and phenprocoumon.
Within the EU there are country to country differences in preferential VKA prescription (1). In Germany and surrounding countries, Phenprocoumon (marketed as Marcoumar or Marcumar) is the most commonly prescribed. The majority of data supporting the development and validation of the LumriaDx INR test has used samples form patients taking Warfarin. The aim of this study is to evaluate the INR levels in patients taking phenprocoumon using the LumiraDx Point of Care INR test and comparing the results to the laboratory reference method , the ACL Elite Pro. Comparison will also be made with the Roche Coaguchek point of care INR test (point of care reference method).
This study is an observational, cross-sectional study with 100 patients in total. Devices used in this study are CE marked for INR measurement by healthcare professionals. This study will be conducted according to the principles of Good Clinical Practice (ICH GCP E6(R2)), International Conference on Harmonization Guidelines as applicable to devices, applicable geographical regulations and institutional research policies and procedures.
For part 1 of the study (25 patients), one venous whole blood draw will be performed (~9mL) into two anti-coagulated collection tubes (2 x 4.5mL 3.2% trisodium citrate). These tubes will then by processed to plasma by centrifugation, stored in Eppendorf tubes, labelled and frozen at -80ºC . These will then be transferred to the LumriaDx laboratory in Scotland, UK, for subsequent measurement of INR with the reference device IL ACL Elite Pro Coagulation Analyzer (ACL) and with the LumiraDx POC INR test.
For part 2 of the study (75 patients), one finger-stick sample of capillary blood (~10µl/sample) from each subject, will be applied directly to a unique test strip for immediate measurement of INR on the LumiraDx Instrument. One further fingerstick sample is then obtained (~10µl/sample) from a separate finger for immediate measurement of INR on the Coaguchek PRO. Post-testing, samples will be disposed securely. From each patient, one venous whole blood draw will also be performed (~9mL) into two anti-coagulated collection tubes (2 x 4.5mL 3.2% trisodium citrate). These tubes will then by processed to plasma by centrifugation, stored in Eppendorf tubes, labelled and frozen at -80ºC. These will then be transferred to the LumiraDx laboratory in Scotland, UK, for subsequent measurement of INR with the reference device IL ACL Elite Pro Coagulation Analyzer (ACL) and with the LumiraDx POC INR test.
INR results obtained will be used in comparative analyses of performance designed to meet the study objectives.
- Conditions
- Anticoagulants and Bleeding Disorders
- Being tested
- Venous and Fingerstick blood draws, Venous blood draw
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous and Fingerstick blood drawsDiagnostic test
Also called Venous and capillary blood draws
Fingerstick sampling to collect blood from subjects Venepuncture to collect blood samples from subjects
Venous blood drawDiagnostic test
Venepuncture to collect blood samples from subjects
| Study group | Role | What they receive |
|---|---|---|
| Venous only | One venous whole blood draw will be performed into two anti-coagulated collection tubes Receives: Diagnostic Test: Venous blood draw | |
| Fingerstick and Venous | One finger-stick sample of capillary blood (~10µl/sample) from each subject, will be applied directly to a unique test strip for immediate measurement of INR on the LumiraDx Instrument. One further fingerstick sample is then obtained (~10µl/sample) from a separate finger for immediate measurement of INR on the Coaguchek PRO. From each patient, one venous whole blood draw will also be performed into two anti-coagulated collection tubes. Receives: Diagnostic Test: Venous and Fingerstick blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the agreement of INR measurements of capillary whole blood as assessed by the LumiraDx POC INR test to INR measurements of venous plasma as assessed by the IL ACL ELITE PRO reference method.
Measurement of INR using Venous blood
Measured: 6 weeks
Secondary outcomes (1)
To determine the agreement of INR measurements of capillary whole blood as assessed by the LumiraDx POC INR test to INR measurements of capillary blood as assessed by Coaguchek Pro II.
Measurement of INR using Venous and capillary blood
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start9 May 2019
- Primary completion30 Jul 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulants and Bleeding DisordersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiraDx UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heinz Voller, Principal investigator, Haematologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074980
- Sponsor's protocol ID
- S-CLIN-PROT-00013
- Acronym
- VKA_GERMANY
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2019
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post CE Study: Evaluation of the Accuracy of INR Results From Patients Taking Phenprocoumon as Anticoagulant When Measured Using the Lumiradx INR Test
- ClinicalTrials.gov ID
- NCT04074980
- Acronym / sponsor ID
- VKA_GERMANY / S-CLIN-PROT-00013
- Conditions
- Anticoagulants and Bleeding Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- LumiraDx UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 May 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 30 Aug 2019 (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.
This study is to evaluate the INR levels in patients taking phenprocoumon using the LumiraDx Point of Care INR test and comparing the results to the laboratory reference method , the ACL Elite Pro. Comparison will also be made with the Roche Coaguchek point of care INR test (point of care reference method). Performance will be demonstrated across a subject population of adult males and females in receipt of Phenprocoumon VKA therapy. This population is representative of the indications for use of the CE marked product. Operators will be trained clinical site staff. Venous plasma and capillary whole blood samples will be obtained from each subject in order to assess accuracy of the the LumiraDx Platform when compared to the reference devices (ACL Elite and Coaguchek Pro).
Detailed description
Vitamin K antagonists (VKA) are a group of substances that reduce blood clotting by reducing the action of vitamin K. They are used in anticoagulant medications in the prevention of thrombosis. The drugs work by depleting the active form of the vitamin by inhibiting Vitamin K epoxide reductase and thus the recycling of inactive vitamin K back to the active reduced form. The most widely prescribed VKAs are Coumarins. This group is composed of several different structurally similar molecules and includes warfarin (Coumadin), acenocoumerol and phenprocoumon.
Within the EU there are country to country differences in preferential VKA prescription (1). In Germany and surrounding countries, Phenprocoumon (marketed as Marcoumar or Marcumar) is the most commonly prescribed. The majority of data supporting the development and validation of the LumriaDx INR test has used samples form patients taking Warfarin. The aim of this study is to evaluate the INR levels in patients taking phenprocoumon using the LumiraDx Point of Care INR test and comparing the results to the laboratory reference method , the ACL Elite Pro. Comparison will also be made with the Roche Coaguchek point of care INR test (point of care reference method).
This study is an observational, cross-sectional study with 100 patients in total. Devices used in this study are CE marked for INR measurement by healthcare professionals. This study will be conducted according to the principles of Good Clinical Practice (ICH GCP E6(R2)), International Conference on Harmonization Guidelines as applicable to devices, applicable geographical regulations and institutional research policies and procedures.
For part 1 of the study (25 patients), one venous whole blood draw will be performed (~9mL) into two anti-coagulated collection tubes (2 x 4.5mL 3.2% trisodium citrate). These tubes will then by processed to plasma by centrifugation, stored in Eppendorf tubes, labelled and frozen at -80ºC . These will then be transferred to the LumriaDx laboratory in Scotland, UK, for subsequent measurement of INR with the reference device IL ACL Elite Pro Coagulation Analyzer (ACL) and with the LumiraDx POC INR test.
For part 2 of the study (75 patients), one finger-stick sample of capillary blood (~10µl/sample) from each subject, will be applied directly to a unique test strip for immediate measurement of INR on the LumiraDx Instrument. One further fingerstick sample is then obtained (~10µl/sample) from a separate finger for immediate measurement of INR on the Coaguchek PRO. Post-testing, samples will be disposed securely. From each patient, one venous whole blood draw will also be performed (~9mL) into two anti-coagulated collection tubes (2 x 4.5mL 3.2% trisodium citrate). These tubes will then by processed to plasma by centrifugation, stored in Eppendorf tubes, labelled and frozen at -80ºC. These will then be transferred to the LumiraDx laboratory in Scotland, UK, for subsequent measurement of INR with the reference device IL ACL Elite Pro Coagulation Analyzer (ACL) and with the LumiraDx POC INR test.
INR results obtained will be used in comparative analyses of performance designed to meet the study objectives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venous only | – | Diagnostic Test: Venous blood drawOne venous whole blood draw will be performed into two anti-coagulated collection tubes |
| Fingerstick and Venous | – | Diagnostic Test: Venous and Fingerstick blood drawsOne finger-stick sample of capillary blood (~10µl/sample) from each subject, will be applied directly to a unique test strip for immediate measurement of INR on the LumiraDx Instrument. One further fingerstick sample is then obtained (~10µl/sample) from a separate finger for immediate measurement of INR on the Coaguchek PRO. From each patient, one venous whole blood draw will also be performed into two anti-coagulated collection tubes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 102 subjects (24 female and 78 male) taking Phenprocoumon. Ages ranged from 36 - 88 years.
Key inclusion criteria (4 listed)
- Persons >18 years of age
- Willing and able to provide written informed consent and comply with study procedures
- Currently prescribed Phenprocoumon VKA Therapy
- Deemed medically appropriate for study participation by the Investigator
Key exclusion criteria (6 listed)
- Subject has previously participated in this part of the study
- Subject is within 4 weeks of first prescription of Phenprocoumon
- Subject is taking a DOAC, or non-Phenprocoumon VKA therapy
- Confirmed or suspected pregnancy
- Vulnerable populations deemed inappropriate for study by the Investigator
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 |
|---|---|---|
| Venous and Fingerstick blood drawsAlso: Venous and capillary blood drawsFingerstick sampling to collect blood from subjects Venepuncture to collect blood samples from subjects | Diagnostic test | Fingerstick and Venous |
| Venous blood drawVenepuncture to collect blood samples from subjects | Diagnostic test | Venous only |
Primary outcome
To determine the agreement of INR measurements of capillary whole blood as assessed by the LumiraDx POC INR test to INR measurements of venous plasma as assessed by the IL ACL ELITE PRO reference method.
Time frame: 6 weeks
Measurement of INR using Venous blood
1 secondary outcome
To determine the agreement of INR measurements of capillary whole blood as assessed by the LumiraDx POC INR test to INR measurements of capillary blood as assessed by Coaguchek Pro II.
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Anticoagulants and Bleeding Disorders
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
RecruitingPhase 3
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
Blood Loss, Surgical, Coagulation Disorder
Enrolling by invitationPhase 4
LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology
Sarcoma, Soft Tissue Sarcoma
RecruitingObservational study
Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam
Cerebral Venous Thrombosis
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. This study is not recruiting at the moment.
Heinz Voller principal investigator
Haematologist
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 Anticoagulants and Bleeding Disorders, run by LumiraDx UK Limited at 1 site in Germany.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jun 2026. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the agreement of INR measurements of capillary whole blood as assessed by the LumiraDx POC INR test to INR measurements of venous plasma as assessed by the IL ACL ELITE PRO reference method. (time frame: 6 weeks). 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 12 Jun 2026.