Specific PoC Testing of Coagulation in Patients Treated With DOAC 1

University Hospital Tuebingen160 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Anticoagulation With NOAC

Interventions

anti-Xa activity point-of-care testing (aXa-POCT)OTHER

ecarin clotting time point-of-care testing (ECT-POCT)OTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Tuebingen

Tübingen, Germany

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels

Time frame: 24 hours

Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay

Time frame: 24 hours

Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay

Time frame: 24 hours

Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay

Time frame: 24 hours

Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay

Time frame: 24 hours

Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) assay

Time frame: 24 hours

Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay

Time frame: 24 hours

Correlation of edoxaban plasma concentrations with CoaguChek point-of-care prothrombin time (PT) assay

Time frame: 24 hours

Central Contacts

Sven Poli, MD MSc

CONTACT

+497071290 sven.poli@uni-tuebingen.de

Florian Härtig, MD

CONTACT

+497071290 florian.haertig@uni-tuebingen.de

Data from ClinicalTrials.gov

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