Clinical Performance Evaluation of T-TAS 01 PL Chip

Completed

• Conditions: Healthy; Congenital Platelets Abnormality; Platelet Dysfunction; Von Willebrand Diseases
• Interventions: Diagnostic Test: T-TAS 01 PL Chip; Diagnostic Test: PFA-100 Col/Epi and Col/ADP

• Registration Number: NCT03621020
• Lead Sponsor: Hikari Dx, Inc.

Brief Summary

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

Detailed Description

This study will measure primary hemostatic ability using the T-TAS 01 System with PL chip, with a comparison to clinical truth. The study will be conducted at 3 locations in the United States and will enroll approximately 335 subjects. The following subject populations will be enrolled into the study (expected enrollment numbers indicated in parentheses):

* Ostensibly healthy subjects without primary hemostasis abnormalities, e.g. a "healthy platelet" normal control population (N = 150)

* Subjects taking 81+ mg daily aspirin (N = 81)

* Subjects taking dual antiplatelet therapy (N = 51)

* Subjects with von Willebrand disease (vWD; N = 47)

* Subjects with Glanzmann's thrombasthenia (N = 5)

Subjects may be recruited either prospectively or based on their simultaneous participation in other studies involving blood collection, provided that the enrollment criteria. Blood samples will be collected after enrollment and subject participation will be complete after blood samples are collected and all necessary information is collected to complete the case report form (CRF). Blood sample testing with T-TAS 01 will occur locally at each investigational site. Blood sample testing for clinical truth assessment may be tested either locally or remotely, depending on the local availability of the various tests used for determining clinical truth.

Study Timeline

• Study First Submitted: 2018-08-05
• Study First Submitted QC: 2018-08-05
• Study First Posted: 2018-08-08
• Study Start: 2018-09-01
• Status Verified: 2020-02
• Primary Completion: 2020-02-14
• Study Completion: 2020-02-14
• Last Update Submitted: 2020-02-15
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	PFA-100 Col/Epi and Col/ADP	Subjects not taking medications with antiplatelet effects, without evidence of vWD or history of congenital platelet abnormalities, without history of significant bleeding.
Aspirin monotherapy	PFA-100 Col/Epi and Col/ADP	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.
Healthy controls	T-TAS 01 PL Chip	Subjects not taking medications with antiplatelet effects, without evidence of vWD or history of congenital platelet abnormalities, without history of significant bleeding.
Glanzmann's Thrombasthenia	T-TAS 01 PL Chip	Subjects diagnosed with Glanzmann's Thrombasthenia, not taking medications with antiplatelet effects, and history of clinically significant bleeding.
von Willebrand Disease	PFA-100 Col/Epi and Col/ADP	Subjects diagnosed with vWD (all types except Type 2N), not taking medications with antiplatelet effects, and history of clinically significant bleeding.
Glanzmann's Thrombasthenia	PFA-100 Col/Epi and Col/ADP	Subjects diagnosed with Glanzmann's Thrombasthenia, not taking medications with antiplatelet effects, and history of clinically significant bleeding.
Dual antiplatelet therapy (DAPT)	T-TAS 01 PL Chip	Subjects taking 81 mg daily aspirin and either 75 mg daily clopidogrel, 10 mg daily prasugrel, or 180 mg daily ticagrelor
Aspirin monotherapy	T-TAS 01 PL Chip	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.
von Willebrand Disease	T-TAS 01 PL Chip	Subjects diagnosed with vWD (all types except Type 2N), not taking medications with antiplatelet effects, and history of clinically significant bleeding.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity for detecting defects in primary hemostasis	Baseline	Sensitivity and specificity of the T-TAS 01 PL chip assay against clinical truth

Trial Locations

Locations (6)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Inova Cardiology Baltimore; 🇺🇸 Lutherville, Maryland, United States

Inova Heart and Vascular Institute; 🇺🇸 Falls Church, Virginia, United States

Centre Hospitalier Universitaire de Bordeaux; 🇫🇷 Bordeaux, CA, France