Clinical Performance Evaluation of T-TAS 01 PL Chip

NCT03621020 | Completed FDA Device

• 1 other identifier: TQPL-RD-121-1
• Study Type: observational
• Target: 307
• Locations: 2 countries
• Sites: 6

Brief Summary

This study will measure primary hemostatic ability using the T-TAS 01 System with PL chip, with a comparison to clinical truth.

Conditions

Platelet Dysfunction; Von Willebrand Diseases; Healthy; Congenital Platelets Abnormality

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity for detecting defects in primary hemostasis

  Sensitivity and specificity of the T-TAS 01 PL chip assay against clinical truth

  Baseline

Study Arms (5)

Healthy controls

Subjects not taking medications with antiplatelet effects, without evidence of vWD or history of congenital platelet abnormalities, without history of significant bleeding.

Diagnostic Test: T-TAS 01 PL Chip; Diagnostic Test: PFA-100 Col/Epi and Col/ADP

Aspirin monotherapy

Subjects taking 81+ mg daily aspirin and no additional medications with antiplatelet effects, without evidence of vWD or history of congenital platelet abnormalities, without history of significant bleeding.

Diagnostic Test: T-TAS 01 PL Chip; Diagnostic Test: PFA-100 Col/Epi and Col/ADP

von Willebrand Disease

Subjects diagnosed with vWD (all types except Type 2N), not taking medications with antiplatelet effects, and history of clinically significant bleeding.

Diagnostic Test: T-TAS 01 PL Chip; Diagnostic Test: PFA-100 Col/Epi and Col/ADP

Glanzmann's Thrombasthenia

Subjects diagnosed with Glanzmann's Thrombasthenia, not taking medications with antiplatelet effects, and history of clinically significant bleeding.

Diagnostic Test: T-TAS 01 PL Chip; Diagnostic Test: PFA-100 Col/Epi and Col/ADP

Dual antiplatelet therapy (DAPT)

Subjects taking 81 mg daily aspirin and either 75 mg daily clopidogrel, 10 mg daily prasugrel, or 180 mg daily ticagrelor

Diagnostic Test: T-TAS 01 PL Chip

Interventions

T-TAS 01 PL Chip DIAGNOSTIC_TEST

Flow chamber microchip system specific for measuring primary hemostatic ability

Aspirin monotherapy; Dual antiplatelet therapy (DAPT); Glanzmann's Thrombasthenia; Healthy controls; von Willebrand Disease

PFA-100 Col/Epi and Col/ADP DIAGNOSTIC_TEST

System for measuring platelet dysfunction

Aspirin monotherapy; Glanzmann's Thrombasthenia; Healthy controls; von Willebrand Disease

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ostensibly healthy subjects without primary hemostasis abnormalities, e.g. a "healthy platelet" normal control population Subjects taking 81+ mg daily aspirin Subjects taking dual antiplatelet therapy Subjects with von Willebrand disease (vWD) Subjects with Glanzmann's thrombasthenia

You may qualify if:

• Males and females age 21 years or older.

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 14 days, e.g. aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol.
• Use of anticoagulant drugs within the past 14 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
• Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, rofecoxib, etc. within the past 14 days.
• 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.
• History of bleeding, with Bleeding Score ≥ 5 (Tosetto J Thromb Haemost 2006). See Appendix A. Scores will be assigned based on health history according to the following categories:
• Epistaxis
• Cutaneous bleeding
• Bleeding from minor wounds
• Bleeding from oral cavity
• Gastrointestinal bleeding

Sponsors & Collaborators

• Hikari Dx, Inc.: lead
• Fujimori Kogyo Co., Ltd.: collaborator

Study Sites (6)

San Francisco General Hospital

San Francisco, California, 94112, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Inova Cardiology Baltimore

Lutherville, Maryland, 21093, United States

Location

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, CA, 92131, France

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 Officials

• Jeffrey Dahlen, Ph.D.

  Hikari Dx, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 8, 2018
• Study Start: September 1, 2018
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); US (5)