T-TAS® wS Method Comparison

NCT06710262 | Completed FDA Device

• 1 other identifier: NX-VAP-AP-I0001
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 2

Brief Summary

This study involves the collection of blood samples and measurement with the T-TAS PL assay to compare the performance of the T-TAS wS instrument to the T-TAS 01 instrument

Conditions

Antiplatelet Therapy; Healthy Donors; Von Willebrand Disease (VWD)

Keywords

T-TAS; Primary hemostasis

Outcome Measures

Primary Outcomes (1)

• Method agreement

  Agreement of PL assay AUC results between the T-TAS wS and T-TAS 01 measurement systems

  For each enrolled subject, following testing of blood sample with the T-TAS PL assay; data will be compiled and analyzed in aggregate at the time of study completion.

Study Arms (4)

Healthy donors

Subjects with no evidence of primary hemostasis abnormalities

Diagnostic Test: T-TAS PL Assay

Aspirin monotherapy

Subjects taking aspirin monotherapy

Diagnostic Test: T-TAS PL Assay

Dual antiplatelet therapy

Subjects taking dual antiplatelet therapy (aspirin plus either clopidogrel, prasugrel, or ticagrelor)

Diagnostic Test: T-TAS PL Assay

Von Willebrand Disease

Subjects with a prior diagnosis of Von Willebrand Disease

Diagnostic Test: T-TAS PL Assay

Interventions

T-TAS PL Assay DIAGNOSTIC_TEST

The T-TAS PL assay is a flow chamber assay for measuring primary hemostatic function

Aspirin monotherapy; Dual antiplatelet therapy; Healthy donors; Von Willebrand Disease

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital or clinic patients, healthy volunteers

You may qualify if:

• Males and females age 21 years or older.
• Able and willing to provide written informed consent.

You may not qualify if:

• Hospitalization or doctor's visits within prior 30 days, except for routine checkup/physical examination.
• Use of antiplatelet therapy within the past 7 days, e.g. aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol.
• Use of anticoagulant drugs within the past 7 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
• Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) that inhibit COX-1 such as naproxen or ibuprofen within the past 3 days, unless confirmed to not inhibit platelet activity (such as celecoxib).
• History of anemia.
• Known thrombocytopenia (platelet count \< 100,000/μL).
• Significant renal dysfunction or dialysis.
• History of platelet disorders e.g. von Willebrand factor deficiency, Glanzmann's thrombasthenia or Bernard-Soulier syndrome.
• History of hemophilia or bleeding disorders.
• Known active gastrointestinal disease including peptic ulcers, gastro-esophageal reflux disease (GERD), and hyperacidity.
• Currently participating in a study involving an investigational drug or compound known to affect coagulation or hemostasis.
• Subjects with significant past medical history as determined by the Investigator that would pose safety concerns or interfere with the study goals.
• Antiplatelet Therapy Subjects
• Males and females age 21 years or older.
• One of the following antiplatelet therapy regimens:

Sponsors & Collaborators

• Hikari Dx, Inc.: lead
• ZACROS Corporation: collaborator

Study Sites (2)

University of Florida Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

MeSH Terms

Conditions

von Willebrand Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 29, 2024
• Study Start: August 21, 2024
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)