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Clinical Trials in Belgium / NCT06582563
Starting soon Observational

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

NCT06582563 · tracked via the Priya Life Science Belgium tracker
Sponsor
Perosphere Technologies Inc
Phase
Observational
Started
2025-03-01
Last updated
2024-10-08

Condition(s) studied

Blood Coagulation Disorder

Investigational drug(s) / intervention(s)

Whole Blood Clotting Time

Whole Blood Clotting Time: Comparator

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
UZ Leuven Hospital Leuven Belgium
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06582563 on ClinicalTrials.gov ↗ ← All trials in Belgium