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Evaluation of the Accuracy of INR Results From Patients Taking Phenprocoumon as Anticoagulant When Measured Using the Lumiradx INR Test (VKA GERMANY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074980
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
LumiraDx UK Limited

Brief 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). 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).

Condition or disease Intervention/treatment Phase
Anticoagulants and Bleeding Disorders Diagnostic Test: Venous and Fingerstick blood draws Diagnostic Test: Venous blood draw Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 9, 2019
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Venous only
One venous whole blood draw will be performed into two anti-coagulated collection tubes
Diagnostic Test: Venous blood draw
Venepuncture to collect blood samples from subjects

Experimental: 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.
Diagnostic Test: Venous and Fingerstick blood draws
Fingerstick sampling to collect blood from subjects Venepuncture to collect blood samples from subjects
Other Name: Venous and capillary blood draws




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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. [ Time Frame: 6 weeks ]
    Measurement of INR using Venous and capillary blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074980


Locations
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Germany
CLINICAL SITE Klinik am See, Rehabilitation Clinic for Cardiovascular Diseases, Ruedersdorf/Berlin.
Rüdersdorf, Germany
Sponsors and Collaborators
LumiraDx UK Limited
Investigators
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Principal Investigator: Heinz Voller Haematologist
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Responsible Party: LumiraDx UK Limited
ClinicalTrials.gov Identifier: NCT04074980    
Other Study ID Numbers: S-CLIN-PROT-00013
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders