Clinical Performance Evaluation of T-TAS®01 HD Chip

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
• •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.