Clinical Performance Evaluation of T-TAS®01 HD Chip
Completed
Conditions studied: Thrombocytopenia
In brief
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.
Key facts
- Study ID
- NCT06087198
- Run by
- Hikari Dx, Inc.
- People needed
- 43
- Starts
- 2023-09-25
- Expected to finish
- 2025-06-30
- Last updated by the study team
- 2025-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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
- 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)
Where it is running
- San Francisco General Hospital — San Francisco, California, United States
- University of Colorado Anschutz Medical Campus — Denver, Colorado, United States
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Duke University — Durham, North Carolina, United States
- University of Oklahoma — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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