Specific PoC Testing of Coagulation in Patients Treated With DOAC 1

• Conditions: Anticoagulation With NOAC

• Registration Number: NCT02825394
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-07
• Study Start: 2016-10-13
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-16
• Primary Completion: 2021-03
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo point-of-care testing (POCT) result	24 hours	DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry

Secondary Outcome Measures

Name	Time	Method
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
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 edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time low-range (ACT-LR) 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

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany