Clinical Performance Evaluation of T-TAS®01 HD Chip

For people ages 18 years and up

Healthy Donors:

Inclusion Criteria:

• Males and females age 18 years or older.
• Able and willing to provide written informed consent.

Exclusion Criteria:

• 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

Exclusion Criteria:

• Use of antiplatelet therapy within the past 14 days, e.g. aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol, abciximab, eptifibatide within the past 14 days.
• Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) known to affect platelet function such as rofecoxib, etc. within the past 14 days, unless confirmed to not inhibit platelet activity (such as celecoxib).
• Surgical procedure on the same day as the baseline blood sample collection and testing
• Surgical procedure after baseline sample collection and testing, and prior to completion of all post-transfusion blood sample collection and testing
• Significant renal dysfunction (eGFR < 30 mL/min/1.73 m2) or dialysis.
• History of platelet disorders e.g. von Willebrand factor deficiency, Glanzmann thrombasthenia or Bernard-Soulier syndrome.
• History of hemophilia or bleeding disorders.
• 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.