Clinical Performance Evaluation of T-TAS®01 HD Chip

NCT06087198 | Completed FDA Device

• 1 other identifier: GE-0035
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 6

Brief Summary

The study is being conducted to validate the clinical performance of the T-TAS 01 HD assay for measurement of thrombogenicity in patients with thrombocytopenia receiving a platelet transfusion.

Conditions

Thrombocytopenia

Keywords

Thrombogenicity; Platelet transfusion; In vitro diagnostic; Bleeding risk

Outcome Measures

Primary Outcomes (2)

• Baseline thrombogenicity

  Proportion of T-TAS 01 HD area under the curve (AUC) \< 700

  Baseline

• Improvement in thrombogenicity

  Difference in proportion of T-TAS 01 HD AUC \< 700 between pre-transfusion and post-transfusion measurements

  Day 1 after platelet transfusion

Secondary Outcomes (4)

• Correlation with bleeding risk

  Day 1 after transfusion

• Comparison of pre-and post-transfusion thrombogenicity

  Day 1 after platelet transfusion

• Comparison of pre-and post-transfusion thrombogenicity

  Day 1 after platelet transfusion

• Prediction of future platelet transfusions

  Day 1 after platelet transfusion

Study Arms (2)

Healthy Donors

Ostensibly healthy subjects with a normal platelet count and without a history of hemostasis abnormalities, for establishing expected values for quality control

Diagnostic Test: T-TAS 01 HD Assay

Thrombocytopenia Patients

Subjects with thrombocytopenia who are planned to receive a platelet transfusion who have pre-transfusion and post-transfusion blood samples collected for testing

Diagnostic Test: T-TAS 01 HD Assay

Interventions

T-TAS 01 HD Assay DIAGNOSTIC_TEST

Disposable flow chamber microchip containing thrombogenic path to facilitate thrombus formation and occlusion

Healthy Donors; Thrombocytopenia Patients

Eligibility Criteria

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

Study Population

* Ostensibly healthy subjects with a normal platelet count and without a history of hemostasis abnormalities, for establishing expected values for quality control (N = up to 50) * Subjects with thrombocytopenia who are planned to receive a platelet transfusion who have pre-transfusion and post-transfusion blood samples collected for testing (N = 50; up to 90 will be enrolled in the event that some subjects do not receive platelet transfusions after enrollment)

You may qualify if:

• Males and females age 18 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 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) that inhibit COX-1 such as rofecoxib, etc. within the past 14 days, unless confirmed to not inhibit platelet activity (such as celecoxib).
• History of anemia.
• Known thrombocytopenia (platelet count \< 100,000/μL).
• Significant renal dysfunction (eGFR \< 30 mL/min/1.73 m2) 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 clinically significant bleeding requiring physician consultation or visit to healthcare facility.
• Females who are in the last trimester of pregnancy or are breastfeeding.
• 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.
• Thrombocytopenia Patients

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 Colorado Anschutz Medical Campus

Denver, Colorado, 80217, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Jeffrey Dahlen, Ph.D.

  Hikari Dx, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: September 25, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)