Clinical Performance Evaluation of T-TAS 01 PL Chip

Completed

Conditions studied: Platelet Dysfunction, Von Willebrand Diseases, Healthy, Congenital Platelets Abnormality

In brief

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

Key facts

Study ID

NCT03621020

Run by

Hikari Dx, Inc.

People needed

307

Starts

2018-09-01

Expected to finish

2020-02-14

Last updated by the study team

2020-02-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females age 21 years or older.
• Able and willing to provide written informed consent. Exclusion Criteria
• Abnormal results from assays used to establish clinical truth (retrospective exclusion).
• 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
• Bleeding from tooth extraction
• Surgical bleeding
• Menorrhagia
• Post-partum hemorrhage
• Muscle hematoma
• Hemarthrosis
• Central nervous system bleeding

Where it is running

• San Francisco General Hospital — San Francisco, California, United States
• University of Iowa — Iowa City, Iowa, 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

Full record on ClinicalTrials.gov

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