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Not yet recruiting NCT06582563

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

— Observational Blood Coagulation Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Whole Blood Clotting Time.
Who it may be relevant to
Registry conditions: Blood Coagulation Disorder. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times

Overview

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 test Whole Blood Clotting Time
    Comparator

Primary outcome measures

  • Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices [Time frame: Immediate]
Secondary outcome measures (1)
  • Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay [Time frame: Immediate]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • UZ Leuven Hospital — Leuven

Identifiers

NCT: NCT06582563 · CP-01-02-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗