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

University Hospital Tuebingen

Status: Unknown

Conditions: Anticoagulation With NOAC

Treatments: Other: ecarin clotting time point-of-care testing (ECT-POCT); Other: anti-Xa activity point-of-care testing (aXa-POCT)

Study type: Observational

Funder types: Other

Identifiers

NCT02825394

270/2015BO1

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 8 patient groups

apixaban initiation

Description:

N=20

Treatment:

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

apixaban on-treatment

Description:

N=20

Treatment:

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

dabigatran initiation

Description:

N=20

Treatment:

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

dabigatran on-treatment

Description:

N=20

Treatment:

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

rivaroxaban initiation

Description:

N=20

Treatment:

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

rivaroxaban on-treatment

Description:

N=20

Treatment:

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

edoxaban initiation

Description:

N=20

Treatment:

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

edoxaban on-treatment

Description:

N=20

Treatment:

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