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

NCT06582563 | Not Yet Recruiting FDA Device

• 1 other identifier: CP-01-02-002
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Blood Coagulation Disorder

Outcome Measures

Primary Outcomes (1)

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

  Whole Blood Clotting Time

  Immediate

Secondary Outcomes (1)

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

  Immediate

Interventions

Whole Blood Clotting Time DIAGNOSTIC_TEST

Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Perosphere Technologies Inc.: lead

Study Sites (1)

UZ Leuven Hospital

Leuven, Belgium

Location

MeSH Terms

Conditions

Blood Coagulation Disorders

Interventions

Whole Blood Coagulation Time

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Peter Verhamme, Professor

CONTACT

3216343491; peter.verhamme@uzleuven.be

Sasha Bakhru, PhD

CONTACT

475 237-4178; s.bakhru@perospheretech.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 3, 2024
• Study Start: March 1, 2025
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

BE (1)