Trials Sponsors Conditions Drugs Pricing

Conditions

Congenital Platelets Abnormality Healthy Platelet Dysfunction Von Willebrand Diseases

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 ChipDiagnostic 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 ChipDiagnostic 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 ChipDiagnostic Test: PFA-100 Col/Epi and Col/ADP

Glanzmann's Thrombasthenia

Interventions

T-TAS 01 PL ChipDiagnostic test

Flow chamber microchip system specific for measuring primary hemostatic ability

Aspirin monotherapyDual antiplatelet therapy (DAPT)Glanzmann's ThrombastheniaHealthy controlsvon Willebrand Disease

PFA-100 Col/Epi and Col/ADPDiagnostic test

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Fujimori Kogyo Co., Ltd.
Type not reportedcollaborator
Hikari Dx, Inc.
Otherlead

Study Sites (6)

San Francisco General Hospital

San Francisco, California, 94112, United States

University of Iowa

Iowa City, Iowa, 52242, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Inova Cardiology Baltimore

Lutherville, Maryland, 21093, United States

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, CA, 92131, France

MeSH Terms

Conditions

von Willebrand Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersBlood Platelet DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

Jeffrey Dahlen, Ph.D.
Hikari Dx, Inc.
STUDY DIRECTOR

Enrollment

307 participants (actual enrollment reported by the registry).

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

Actual (reported)

Clinical Performance Evaluation of T-TAS 01 PL Chip

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (5)

Healthy controls

Aspirin monotherapy

von Willebrand Disease

Glanzmann's Thrombasthenia

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Dual antiplatelet therapy (DAPT)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (5)

Healthy controls

Aspirin monotherapy

von Willebrand Disease

Glanzmann's Thrombasthenia

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Dual antiplatelet therapy (DAPT)

You may not qualify if:

Data Sharing

Source record

Locations