Status:
NOT_YET_RECRUITING
Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants
Lead Sponsor:
Perosphere Technologies Inc.
Conditions:
Blood Coagulation Disorder
Eligibility:
All Genders
18-80 years
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 (...
Eligibility Criteria
Inclusion
- In general, study participants must:
- 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
Exclusion
- Eligible patients on anticoagulants must not:
- 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.
- Have a history of unexplained syncope.
- Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
- Consume more than 5 cigarettes per day.
- If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
- If female is pregnant, breastfeeding, or planning to become pregnant during study
Key Trial Info
Start Date :
March 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06582563
Start Date
March 1 2025
End Date
August 30 2025
Last Update
October 8 2024
Active Locations (1)
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1
UZ Leuven Hospital
Leuven, Belgium