The influence of antiphospholipid antibodies on INR values measured with the CoaguChek XS

The influence of antiphospholipid antibodies on INR values measured with the CoaguChek XS - Effect of antiphospholipid antibodies on INR values

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51121

Enrollment

Registered

2021-04-14

Start date

2021-06-10

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis in the antiphospholipid syndrome

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age 18 years and older - Previously confirmed antiphospholipid syndrome, diagnosed in accordance with the Sydney criteria - Receiving Vitamin K antagonist during at least 3 months - Willing and be able to understand the study information and sign the informed consent form

Exclusion criteria

Exclusion criteria: - None

Design outcomes

Primary

Measure	Time frame
The main study parameter is the difference in INR values measured with the Coaguchek XS and Coagulometer. A difference in INR >0,5 will be considered clinically significant.	—

Secondary

Measure	Time frame
Secondary parameter includes: - The determination of antiphospholipid antibodies: IgG / IgM directed against cardiolipin, β2-Glycoprotein I, phosphatidic acid, phosphatidyl-choline, - ethanolamine, -glycerol, -inositol, -serine, annexin V and prothrombin, and antiphospholipid antibodies that prolong the clotting time in vitro, known as lupus anticoagulant. Lupus anticoagulant will be determined using a dilute Russell*s Viper Venom Time (dRVVT) screen and confirm, and an activated partial tromboplastin time (APTT) screen and confirm. - The evaluation of differences in INR values between triple positive APS patients (patients at highest risk for recurrent thrombosis) and non-triple positive APS patients. Patients are considered as triple positive if they are tested positive for anti-cardiolipin antibodies, anti-β2GPI antibodies and lupus anticoagulant.	—

Measure

Time frame

Secondary parameter includes: - The determination of antiphospholipid antibodies: IgG / IgM directed against cardiolipin, β2-Glycoprotein I, phosphatidic acid, phosphatidyl-choline, - ethanolamine, -glycerol, -inositol, -serine, annexin V and prothrombin, and antiphospholipid antibodies that prolong the clotting time in vitro, known as lupus anticoagulant. Lupus anticoagulant will be determined using a dilute Russell*s Viper Venom Time (dRVVT) screen and confirm, and an activated partial tromboplastin time (APTT) screen and confirm. - The evaluation of differences in INR values between triple positive APS patients (patients at highest risk for recurrent thrombosis) and non-triple positive APS patients. Patients are considered as triple positive if they are tested positive for anti-cardiolipin antibodies, anti-β2GPI antibodies and lupus anticoagulant.

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Countries

Netherlands

Outcome results