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

Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times

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 Overview

• Status: Not yet recruiting
• Conditions: Blood Coagulation Disorder
• Intervention / Treatment: Diagnostic test: Whole Blood Clotting Time

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Sasha Bakhru, PhD; Phone Number: 475 237-4178; Email: s.bakhru@perospheretech.com
• Study Contact Backup: Name: Peter Verhamme, Professor; Phone Number: 3216343491; Email: peter.verhamme@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium
    • UZ Leuven Hospital
    • Contact: Peter Verhamme, Professor; Phone Number: 3216343491; Email: peter.verhamme@uzleuven.be
    • Contact: Sasha Bakhru, PhD; Email: s.bakhru@perospheretech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with rivaroxaban, apixaban, or edoxaban between the ages of 18 and 80 years old. A sufficient number (12 or above) of the patients are above 70 years of age.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices	Whole Blood Clotting Time	Immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay	Drug concentration measurements	Immediate

Collaborators and Investigators

• Sponsor: Perosphere Technologies Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Embolism and Thrombosis; Hemostatic Disorders; Blood Coagulation Disorders; Thrombosis
• Other Study ID Numbers: CP-01-02-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes