Status:
COMPLETED
Evaluation of the Accuracy of INR Results From Patients Taking Phenprocoumon as Anticoagulant When Measured Using the Lumiradx INR Test
Lead Sponsor:
LumiraDx UK Limited
Conditions:
Anticoagulants and Bleeding Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
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. Co...
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 dr...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2019
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04074980
Start Date
May 9 2019
End Date
September 15 2019
Last Update
February 20 2020
Active Locations (1)
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1
CLINICAL SITE Klinik am See, Rehabilitation Clinic for Cardiovascular Diseases, Ruedersdorf/Berlin.
Rüdersdorf, Germany