Clinical trial NCT06582563: Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants
Official title: Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Blood Coagulation Disorder
Lead sponsor: Perosphere Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices
timeFrame: Immediate
Secondary outcomes:
measure: Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay
timeFrame: Immediate
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven Hospital
Study officials:
References: