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

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Recruiting
CT.gov ID
NCT02825394
Collaborator
Heart and Diabetes Center North Rhine-Westphalia (Other)
160
Enrollment
1
Location
56.6
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: anti-Xa activity point-of-care testing (aXa-POCT)
  • Other: ecarin clotting time point-of-care testing (ECT-POCT)

Study Design

Study Type:
Observational
Anticipated Enrollment :
160 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Specific Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Part 1
Actual Study Start Date :
Oct 13, 2016
Anticipated Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels [24 hours]

    2. Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay [24 hours]

    3. Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay [24 hours]

    4. Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay [24 hours]

    5. Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay [24 hours]

    6. Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) assay [24 hours]

    7. Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay [24 hours]

    8. Correlation of edoxaban plasma concentrations with CoaguChek point-of-care prothrombin time (PT) assay [24 hours]

    9. Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care prothrombin time (PT) assay [24 hours]

    10. Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated thromboplastin time (aPTT) assay [24 hours]

    11. Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time plus (ACT+) assay [24 hours]

    12. Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time low-range (ACT-LR) assay [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Tuebingen Tuebingen Germany 72076

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Sven Poli, MD MSc, University Hospital Tuebingen
    ClinicalTrials.gov Identifier:
    NCT02825394
    Other Study ID Numbers:
    • 270/2015BO1
    First Posted:
    Jul 7, 2016
    Last Update Posted:
    Dec 16, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Ecarin

    Study Results

    No Results Posted as of Dec 16, 2020