Specific PoC Testing of Coagulation in Patients Treated With DOAC 1

  • STATUS
    Recruiting
  • days left to enroll
    82
  • participants needed
    160
  • sponsor
    University Hospital Tuebingen
Updated on 27 January 2021

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.

Details
Condition Anticoagulation With NOAC
Treatment anti-Xa activity point-of-care testing (aXa-POCT), ecarin clotting time point-of-care testing (ECT-POCT)
Clinical Study IdentifierNCT02825394
SponsorUniversity Hospital Tuebingen
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Anticoagulation With NOAC?
Do you have any of these conditions: Do you have Anticoagulation With NOAC??
Do you have any of these conditions: Do you have Anticoagulation With NOAC??
Do you have any of these conditions: Do you have Anticoagulation With NOAC??
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
Clear my responses

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