t-tas® ws method comparison

Conditions: Antiplatelet Therapy; Healthy Donors; Von Willebrand Disease (VWD)

Summary: this study involves the collection of blood samples and measurement with the t-tas pl assay to compare the performance of the t-tas ws instrument to the t-tas 01 instrument

this study will compare pl assay measurements obtained with the t-tas ws instrument (subject device) with pl assay measurements obtained with the t-tas 01 instrument (predicate method). the t-tas pl assay will be used to facilitate the comparison between instruments using intended use blood samples from the intended use population. the study will be conducted at a minimum of 3 locations in the united states and will enroll up to 120 subjects. the following subject populations will be enrolled into the study (minimum enrollment numbers indicated in parentheses): * ostensibly healthy subjects * subjects taking 81 mg or higher daily aspirin monotherapy (asa) * subjects taking dual antiplatelet therapy (dapt) * subjects with von willebrand disease (vwd)

Eligibility criteria:
ostensibly healthy donors inclusion criteria: * males and females age 21 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 7 days, e.g. aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol. * use of anticoagulant drugs within the past 7 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban. * use of certain nonsteroidal anti-inflammatory drugs (nsaids) that inhibit cox-1 such as naproxen or ibuprofen within the past 3 days, unless confirmed to not inhibit platelet activity (such as celecoxib). * history of anemia. * known thrombocytopenia (platelet count \< 100,000/μl). * significant renal dysfunction 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. * 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. antiplatelet therapy subjects inclusion criteria: * males and females age 21 years or older. * one of the following antiplatelet therapy regimens: * aspirin monotherapy: * 81 mg or higher aspirin daily for 1 or more days * dual antiplatelet therapy: * 81 mg or higher aspirin plus either 1) ≥300 mg clopidogrel loading dose within the prior 5 days followed by 75 mg daily clopidogrel, or 2) 75 mg daily clopidogrel daily for ≥5 days. * 81 mg or higher aspirin plus either 1) 60 mg prasugrel loading dose within the prior 5 days followed by either 5 or 10 mg daily prasugrel, or 2) 5 or 10 mg daily prasugrel daily for ≥5 days. * 81 mg aspirin plus either 1) 180 mg ticagrelor loading dose within the prior 5 days followed by 2x90 mg daily ticagrelor, or 2) 2x90 mg daily ticagrelor daily for ≥5 days. * able and willing to provide written informed consent. exclusion criteria: * use of antiplatelet therapy other than aspirin, clopidogrel, prasugrel, or ticagrelor (e.g. cilostazol, abciximab, eptifibatide) within the past 7 days. * use of anticoagulant drugs within the past 7 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban. * significant renal dysfunction or dialysis. * known thrombocytopenia (platelet count \< 100,000/μl). * 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. von willebrand disease subjects inclusion criteria: * males and females age 21 years or older. * prior diagnosis of von willebrand disease type 1, 2a, 2b, 2m, or 3 * able and willing to provide written informed consent. exclusion criteria: * prior diagnosis of von willebrand disease type 2n * use of antiplatelet therapy besides aspirin within the past 14 days. * 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 naproxen or ibuprofen within the past 7 days, unless confirmed to not inhibit platelet activity (such as celecoxib). * significant renal dysfunction or dialysis. * known thrombocytopenia (platelet count \< 100,000/μl). * 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.

Keywords: t-tas primary hemostasis