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

Not yet recruiting

• Conditions: Blood Coagulation Disorder

• Registration Number: NCT06582563
• Lead Sponsor: Perosphere Technologies Inc.

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).

Study Timeline

• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-30
• Study First Posted: 2024-09-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Study Start: 2025-03-01
• Primary Completion: 2025-07-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices	Immediate	Whole Blood Clotting Time

Secondary Outcome Measures

Name	Time	Method
Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay	Immediate	Drug concentration measurements

Trial Locations

Locations (1)

UZ Leuven Hospital; 🇧🇪 Leuven, Belgium