Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPerosphere Technologies Inc.

About this trial

Whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.

Be 18- to 80-years-of-age, inclusive, at time of consent.

Have suitable venous access for at least a single venipuncture.

Eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion

Disqualifiers

Other than the condition for which a DOAC was prescribed , have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions.

Have a BMI> 40 or weight > 120kg.

Suffer from renal or hepatic insufficiency.

Suffer from any pathology that would contra-indicate in general DOAC medication.

Trial population

Patients treated with rivaroxaban, apixaban, or edoxaban between the ages of 18 and 80 years old. A sufficient number (12 or above) of the patients are above 70 years of age.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Whole Blood Clotting Time

    Diagnostic test

    Comparator

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices

Whole Blood Clotting Time

Time frame
Immediate

Secondary outcomes

1

Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay

Drug concentration measurements

Time frame
Immediate

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: