Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06582563

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

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Blood Clotting Time

Diagnostic Test

Comparator

Primary outcomes

  1. Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices

    Time frame: Immediate

    Whole Blood Clotting Time

Secondary outcomes

  1. Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay

    Time frame: Immediate

    Drug concentration measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Verhamme, Professor

CONTACT

[email protected]

3216343491

Sasha Bakhru, PhD

CONTACT

[email protected]

475 237-4178

Sponsors and collaborators

Lead sponsor

Perosphere Technologies Inc.

Industry

Registry information

Official study title

Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.