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

Perosphere Technologies Inc.

Status: Not yet enrolling

Conditions: Blood Coagulation Disorder

Treatments: Diagnostic Test: Whole Blood Clotting Time

Study type: Observational

Funder types: Industry

Identifiers

NCT06582563

CP-01-02-002

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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