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In Vitro Diagnostic Test for DOAC in Urine

NCT03182829 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 880

Last updated 2022-04-21

Study results available
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Summary

This trial is conducted to assess the performance and handling of the in vitro diagnostic (IVD) device for oral direct factor Xa and thrombin inhibitors from urine samples of patients on treatment with direct oral anticoagulants Apixaban, Edoxaban, Rivaroxaban, and Dabigatran (DOAC) in an actual point-of-care (POCT) setting in comparison to results obtained by liquid chromatography tandem mass spectrometry (LC-MS/MS) from urine samples.

This trial is conducted to assess the performance and handling of the IVD for oral direct factor Xa and thrombin inhibitors from urine samples of patients on treatment with DOACs in an actual point-of-care setting in comparison to results obtained by liquid chromatography tandem mass spectrometry (LC-MS/MS) from urine samples.

"publication Thromb Haemost. 2019 Nov 8. doi: 10.1055/s-0039-1700545. \[Epub ahead of print\]"

Conditions

  • Anticoagulant Therapy

Interventions

DIAGNOSTIC_TEST

DOAC Dipstick

Patients collect a sample of urine for analysis. "publication Thromb Haemost. 2019 Nov 8. doi: 10.1055/s-0039-1700545. \[Epub ahead of print\]"

Sponsors & Collaborators

  • CRS Clinical Research Services Mannheim GmbH

    collaborator INDUSTRY

  • Heidelberg University

    collaborator OTHER

  • Medical Care Center Dr. Limbach and Colleagues, Heidelberg, Germany

    collaborator OTHER

  • Doasense GmbH

    lead INDUSTRY

Principal Investigators

  • Job Harenberg, Professor · Pneumonologische Schwerpunktpraxis Heidelberg, Privatpraxis Harenberg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2019-04-09
Completion
2019-06-05

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03182829 on ClinicalTrials.gov