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| Name | Class |
|---|---|
| Heart and Diabetes Center North Rhine-Westphalia | OTHER |
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The investigators study aims to test the correlation between the Cascade Abrazo point-of-care testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran, edoxaban and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of direct oral anticoagulants (DOAC) in real-life patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apixaban initiation | N=20 |
| |
| apixaban on-treatment | N=20 |
| |
| dabigatran initiation | N=20 |
| |
| dabigatran on-treatment | N=20 |
| |
| rivaroxaban initiation | N=20 |
| |
| rivaroxaban on-treatment | N=20 |
| |
| edoxaban initiation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-Xa activity point-of-care testing (aXa-POCT) | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo point-of-care testing (POCT) result | DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels | 24 hours | |
| Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Part A: patients, who are newly started on oral anticoagulation with apixaban, dabigatran, edoxaban or rivaroxaban for secondary prevention of thromboembolic events.
Part B: patients, on-treatment with apixaban, dabigatran, edoxaban or rivaroxaban.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sven Poli, MD MSc | Contact | +497071290 | 68300 | sven.poli@uni-tuebingen.de |
| Florian Härtig, MD | Contact | +497071290 | 80417 | florian.haertig@uni-tuebingen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen | Recruiting | Tübingen | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33641678 | Derived | Hartig F, Birschmann I, Peter A, Horber S, Ebner M, Sonnleitner M, Spencer C, Bombach P, Stefanou MI, Tunnerhoff J, Mengel A, Kuhn J, Ziemann U, Poli S. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants including edoxaban. Neurol Res Pract. 2021 Mar 1;3(1):9. doi: 10.1186/s42466-021-00105-4. | |
| 33469905 |
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Whole blood samples, citrated blood samples and citrated plasma samples
N=20 |
|
| edoxaban on-treatment | N=20 |
|
|
| ecarin clotting time point-of-care testing (ECT-POCT) | Other |
|
|
| Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay | 24 hours |
| Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay | 24 hours |
| Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay | 24 hours |
| Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) assay | 24 hours |
| Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay | 24 hours |
| Correlation of edoxaban plasma concentrations with CoaguChek point-of-care prothrombin time (PT) assay | 24 hours |
| Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care prothrombin time (PT) assay | 24 hours |
| Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated thromboplastin time (aPTT) assay | 24 hours |
| Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time plus (ACT+) assay | 24 hours |
| Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time low-range (ACT-LR) assay | 24 hours |
| Hartig F, Birschmann I, Peter A, Ebner M, Spencer C, Gramlich M, Richter H, Kuhn J, Lehmann R, Blumenstock G, Zuern CS, Ziemann U, Poli S. Specific Point-of-Care Testing of Coagulation in Patients Treated with Dabigatran. Thromb Haemost. 2021 Jun;121(6):782-791. doi: 10.1055/s-0040-1721775. Epub 2021 Jan 14. |