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

Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times

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).

Primary objectives of the planned 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).

Inclusion Criteria:

• In general, study participants must:

  1. Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
  2. Be 18- to 80-years-of-age, inclusive, at time of consent.
  3. Have suitable venous access for at least a single venipuncture.
  4. Eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion

Exclusion Criteria:

• Eligible patients on anticoagulants must not:

  1. 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.
  2. Have a BMI> 40 or weight > 120kg.
  3. Suffer from renal or hepatic insufficiency.
  4. Suffer from any pathology that would contra-indicate in general DOAC medication.
  5. Have a history of unexplained syncope.
  6. Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
  7. Consume more than 5 cigarettes per day.
  8. If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
  9. If female is pregnant, breastfeeding, or planning to become pregnant during study