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

NCT04074980 | Completed

• 1 other identifier: S-CLIN-PROT-00013
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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).

Conditions

Anticoagulants and Bleeding Disorders

Outcome Measures

Primary 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 venous plasma as assessed by the IL ACL ELITE PRO reference method.

  Measurement of INR using Venous blood

  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.

  6 weeks

Study Arms (2)

Venous only

EXPERIMENTAL

One venous whole blood draw will be performed into two anti-coagulated collection tubes

Diagnostic Test: Venous blood draw

Fingerstick and Venous

EXPERIMENTAL

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

Interventions

Venous and Fingerstick blood draws DIAGNOSTIC_TEST

Fingerstick sampling to collect blood from subjects Venepuncture to collect blood samples from subjects

Also known as: Venous and capillary blood draws

Fingerstick and Venous

Venous blood draw DIAGNOSTIC_TEST

Venepuncture to collect blood samples from subjects

Venous only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LumiraDx UK Limited: lead

Study Sites (1)

CLINICAL SITE Klinik am See, Rehabilitation Clinic for Cardiovascular Diseases, Ruedersdorf/Berlin.

Rüdersdorf, Germany

Location

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Heinz Voller

  Haematologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: May 9, 2019
• Primary Completion: July 30, 2019
• Study Completion: September 15, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)