Clinical trial NCT02825394: Specific PoC Testing of Coagulation in Patients Treated With DOAC 1
Official title: Specific Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Part 1
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anticoagulation With NOAC
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Heart and Diabetes Center North Rhine-Westphalia
First posted: 2016-07-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Part A only: planned initiation of treatment with apixaban, dabigatran, edoxaban or rivaroxaban
* Part B only: ongoing treatment with apixaban, dabigatran, edoxaban or rivaroxaban
* Age ≥ 18 years
* Written informed consent by patient

Exclusion Criteria:

* Part A only: intake of vitamin K antagonists or direct oral anticoagulants (DOAC) ≤ 14 days prior to study participation
* Part B only: intake of vitamin K antagonists or different DOAC ≤ 14 days prior to study participation
* Intake of unfractionated heparin ≤ 12 hours, low-molecular-weight heparin ≤ 24h, heparinoids (e.g. fondaparinux) ≤ 72h, or direct thrombin inhibitors other than dabigatran ≤ 72h prior to study participation
* Part A only: abnormal routine coagulation test values at baseline (defined by INR \> 1.2, Quick \< 70% or aPTT \> 40 sec)
* History of coagulopathy

Primary outcomes:
measure: Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo point-of-care testing (POCT) result
timeFrame: 24 hours
Secondary outcomes:
measure: Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels
timeFrame: 24 hours
measure: Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay
timeFrame: 24 hours
measure: Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay
timeFrame: 24 hours
measure: Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay
timeFrame: 24 hours
measure: Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay
timeFrame: 24 hours
measure: Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) assay
timeFrame: 24 hours
measure: Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay
timeFrame: 24 hours
measure: Correlation of edoxaban plasma concentrations with CoaguChek point-of-care prothrombin time (PT) assay
timeFrame: 24 hours
measure: Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care prothrombin time (PT) assay
timeFrame: 24 hours
measure: Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated thromboplastin time (aPTT) assay
timeFrame: 24 hours
measure: Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time plus (ACT+) assay
timeFrame: 24 hours
measure: Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time low-range (ACT-LR) assay
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
References:
citation: 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.
citation: 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.