In Vitro Diagnostic Test for DOAC in Urine
PADOASU
Post Marketing Study of an in Vitro Diagnostic Test for Direct Oral Anticoagulants (Apixaban, Edoxaban, Rivaroxaban, Dabigatran) in Urine
1 other identifier
observational
880
1 country
18
Brief 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. \[Epub ahead of print\]"
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
Shorter than P25 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedStudy Start
First participant enrolled
August 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2019
CompletedResults Posted
Study results publicly available
May 4, 2021
CompletedApril 21, 2022
March 1, 2022
8 months
June 8, 2017
December 19, 2019
March 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of Factor Xa and Thrombin Inhibitors Pads of DOAC Dipstick From Urine Samples
Liquid chromatography mass spectrometry versus DOAC Dipstick, qualitative analysis of results
during urine collection and bioanalytical quantification, any time between August 2018 and April 2019
Study Arms (2)
Factor Xa inhibitor
Patients on treatment with Apixaban, Edoxaban or Rivaroxaban are included into the evaluation study at the outpatient care unit. Patients receive treatment for a specific clinical indication such as non-valvular atrial fibrillation or venous thromboembolism since one week or longer. During the study visit DOAC Dipstick test and liquid-chromatography mass-specrotmery are performed to identify absence or presence of Factor Xa inhibitor in urine. "publication Thromb Haemost. 2019 Nov 8. doi: 10.1055/s-0039-1700545. \[Epub ahead of print\]"
Thrombin inhibitor
Patients on treatment with Dabigatran are included included into the evaluation study at the outpatient care unit. Patients receive treatment for a specific clinical indication such as non-valvular atrial fibrillation or venous thromboembolism since one week or longer. During the study visit DOAC Dipstick test and liquid-chromatography mass-specrotmery are performed to identify absence or presence of Thrombin inhibitor in urine. "publication Thromb Haemost. 2019 Nov 8. doi: 10.1055/s-0039-1700545. \[Epub ahead of print\]"
Interventions
Patients collect a sample of urine for analysis. "publication Thromb Haemost. 2019 Nov 8. doi: 10.1055/s-0039-1700545. \[Epub ahead of print\]"
Eligibility Criteria
Patients on routine treatment with Apixaban, Dabigatran, Edoxaban, and Rivaroxaban since 1 week or longer, an age of \>18 years and fulfilling none the exclusion criteria are eligible. The patients participating in this Performance Assessment will be recruited directly at the point of care, i.e., the respective outpatient care unit. "publication Thromb Haemost. 2019 Nov 8. doi: 10.1055/s-0039-1700545. \[Epub ahead of print\]"
You may qualify if:
- Fully signed and dated written informed consent
- Age \>18 years
- Patient is either under therapy with rivaroxaban, apixaban, and edoxaban or dabigatran for at least 1 week
You may not qualify if:
- Patients not able to provide urine samples.
- Patients not able to understand the informed consent or severe mentally disabled.
- Patients in the end-stage of a severe disease.
- "publication Thromb Haemost. 2019 Nov 8. doi: 10.1055/s-0039-1700545. \[Epub ahead of print\]"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Doasense GmbHlead
- CRS Clinical Research Services Mannheim GmbHcollaborator
- Heidelberg Universitycollaborator
- Medical Care Center Dr. Limbach and Colleagues, Heidelberg, Germanycollaborator
Study Sites (18)
Universitätsherzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie II
Bad Krozingen, 79189, Germany
Herz- und Diabeteszentrum NRW, Klinik für Kardiologie
Bad Oeynhausen, 32545, Germany
Vivantes Klinikum im Friedrichshain
Berlin, 10249, Germany
Gerinnungszentrum Sucker
Berlin, 10789, Germany
Vivantes Klinikum Neukölln
Berlin, 12351, Germany
Klinikum Coburg GmbH, II. Medizinische Klinik
Coburg, 96450, Germany
Krankenhaus der Augustinerinnen gGmbH, Klinik für Kardiologie und internistische Intensivmedizin
Cologne, 50678, Germany
Klinikum Darmstadt - Gefäßzentrum
Darmstadt, 64283, Germany
Praxis Innere Medizin, Kardiologie und Angiologie
Dessau, 06846, Germany
Städtisches Klinikum Dresden, II. Medizinische Klinik
Dresden, 01067, Germany
Medizinische Fakultät Carl Gustav Carus, Medizinische Klinik und Poliklinik I
Dresden, 01307, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, 60389, Germany
Klinik für Kardiologie und Angiologie I
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Hamburg-Eppendorf, II. Medizinische Klinik und Poliklinik
Hamburg, 20246, Germany
Kliniken Landkreis Heidenheim
Heidenheim, 89522, Germany
Zentrum für Blutgerinnungsstörungen, MVZ Labor Dr. Reising-Ackermann und Kollegen
Leipzig, 04289, Germany
Zentrum für Praevention und Rehabilitation
Siegen, 57072, Germany
Die Parkkardiologie
Stahnsdorf, 14532, Germany
Related Publications (5)
Harenberg J, Du S, Wehling M, Zolfaghari S, Weiss C, Kramer R, Walenga J. Measurement of dabigatran, rivaroxaban and apixaban in samples of plasma, serum and urine, under real life conditions. An international study. Clin Chem Lab Med. 2016 Feb;54(2):275-83. doi: 10.1515/cclm-2015-0389.
PMID: 26167981BACKGROUNDDu S, Weiss C, Christina G, Kramer S, Wehling M, Kramer R, Harenberg J. Determination of dabigatran in plasma, serum, and urine samples: comparison of six methods. Clin Chem Lab Med. 2015 Jul;53(8):1237-47. doi: 10.1515/cclm-2014-0991.
PMID: 25720084BACKGROUNDHarenberg J, Du S, Kramer S, Weiss C, Kramer R, Wehling M. Patients' serum and urine as easily accessible samples for the measurement of non-vitamin K antagonist oral anticoagulants. Semin Thromb Hemost. 2015 Mar;41(2):228-36. doi: 10.1055/s-0035-1544158. Epub 2015 Feb 15.
PMID: 25682081BACKGROUNDHarenberg J, Schreiner R, Hetjens S, Weiss C. Detecting Anti-IIa and Anti-Xa Direct Oral Anticoagulant (DOAC) Agents in Urine using a DOAC Dipstick. Semin Thromb Hemost. 2019 Apr;45(3):275-284. doi: 10.1055/s-0038-1668098. Epub 2018 Aug 22.
PMID: 30134449BACKGROUNDHarenberg J, Beyer-Westendorf J, Crowther M, Douxfils J, Elalamy I, Verhamme P, Bauersachs R, Hetjens S, Weiss C; Working Group Members. Accuracy of a Rapid Diagnostic Test for the Presence of Direct Oral Factor Xa or Thrombin Inhibitors in Urine-A Multicenter Trial. Thromb Haemost. 2020 Jan;120(1):132-140. doi: 10.1055/s-0039-1700545. Epub 2019 Nov 8.
PMID: 31705521RESULT
Related Links
Biospecimen
urine sample, spontaneously collected from patients "publication Thromb Haemost. 2019 Nov 8. doi: 10.1055/s-0039-1700545. \[Epub ahead of print\]"
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Harenberg, Job Prof Dr.
- Organization
- DOASENSE GmbH
Study Officials
- PRINCIPAL INVESTIGATOR
Job Harenberg, Professor
Pneumonologische Schwerpunktpraxis Heidelberg, Privatpraxis Harenberg
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2017
First Posted
June 9, 2017
Study Start
August 22, 2018
Primary Completion
April 9, 2019
Study Completion
June 5, 2019
Last Updated
April 21, 2022
Results First Posted
May 4, 2021
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share
Individual data of patients are collected during the study and stored centrally at DOASENSE GmbH Heidelberg, Germany. They will be shared with other researchers upon request.