Status:
COMPLETED
Clinical Performance Evaluation of T-TAS®01 HD Chip
Lead Sponsor:
Hikari Dx, Inc.
Collaborating Sponsors:
Fujimori Kogyo Co., Ltd.
Conditions:
Thrombocytopenia
Eligibility:
All Genders
18+ years
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.
Detailed Description
This study will measure the improvement in thrombogenicity following platelet transfusion in patients with thrombocytopenia, using the T-TAS 01 HD assay, with a comparison with clinical truth, defined...
Eligibility Criteria
Inclusion
- Healthy Donors:
- Males and females age 18 years or older.
- Able and willing to provide written informed consent.
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) 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
- Inclusion Criteria:
- Males and females age 18 years or older.
- Known thrombocytopenia, which may be attributed to any of the following:
- Immune thrombocytopenia (ITP)
- Lupus
- Rheumatoid arthritis
- Aplastic anemia
- Thrombotic thrombocytopenic purpura (TTP)
- Disseminated intravascular coagulation (DIC)
- Heparin induced thrombocytopenia (HIT)
- Vaccine-induced thrombotic thrombocytopenia (VITT)
- Infection
- Surgery
- Cancer
- Other etiologies including trauma, portal hypertension, liver disease, etc.
- Platelet count \< 90,000/μL, confirmed by pre-transfusion CBC
- Planned platelet transfusion.
- Able and willing to provide written informed consent
Key Trial Info
Start Date :
September 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06087198
Start Date
September 25 2023
End Date
June 30 2025
Last Update
July 28 2025
Active Locations (6)
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1
San Francisco General Hospital
San Francisco, California, United States, 94112
2
University of Colorado Anschutz Medical Campus
Denver, Colorado, United States, 80217
3
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
4
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198