Specific PoC Testing of Coagulation in Patients Treated With DOAC 1 (SPOCT-DOAC 1)

Specific Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Part 1

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 Overview

• Status: Unknown
• Conditions: Anticoagulation With NOAC
• Intervention / Treatment: Other: anti-Xa activity point-of-care testing (aXa-POCT); Other: ecarin clotting time point-of-care testing (ECT-POCT)

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72076
    • Recruiting
    • University Hospital Tuebingen
    • Contact: Sven Poli, MD MSc; Phone Number: 68300 +497071290; Email: sven.poli@uni-tuebingen.de
    • Contact: Florian Härtig, MD; Phone Number: 80417 +497071290; Email: florian.haertig@uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
apixaban initiation; N=20	Other: anti-Xa activity point-of-care testing (aXa-POCT); Other Names: Cascade Abrazo with ENOX and ENOX LR test cards
apixaban on-treatment; N=20	Other: anti-Xa activity point-of-care testing (aXa-POCT); Other Names: Cascade Abrazo with ENOX and ENOX LR test cards
dabigatran initiation; N=20	Other: ecarin clotting time point-of-care testing (ECT-POCT); Other Names: Cascade Abrazo with DTM test cards
dabigatran on-treatment; N=20	Other: ecarin clotting time point-of-care testing (ECT-POCT); Other Names: Cascade Abrazo with DTM test cards
rivaroxaban initiation; N=20	Other: anti-Xa activity point-of-care testing (aXa-POCT); Other Names: Cascade Abrazo with ENOX and ENOX LR test cards
rivaroxaban on-treatment; N=20	Other: anti-Xa activity point-of-care testing (aXa-POCT); Other Names: Cascade Abrazo with ENOX and ENOX LR test cards
edoxaban initiation; N=20	Other: anti-Xa activity point-of-care testing (aXa-POCT); Other Names: Cascade Abrazo with ENOX and ENOX LR test cards
edoxaban on-treatment; N=20	Other: anti-Xa activity point-of-care testing (aXa-POCT); Other Names: Cascade Abrazo with ENOX and ENOX LR test cards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Heart and Diabetes Center North Rhine-Westphalia

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2016
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Ecarin
• Other Study ID Numbers: 270/2015BO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided