Blood Coagulation Disorder
Conditions
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).
Interventions
DIAGNOSTIC_TESTWhole Blood Clotting Time
Comparator
Sponsors
Perosphere Technologies Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices | Immediate | Whole Blood Clotting Time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay | Immediate | Drug concentration measurements |
Countries
Belgium
Contacts
Primary ContactPeter Verhamme, Professor
Backup ContactSasha Bakhru, PhD
Outcome results
None listed