Clinical Performance Evaluation of T-TAS®01 HD Chip (NCT06087198) | Clinical Trial Compass
CompletedNot Applicable
Clinical Performance Evaluation of T-TAS®01 HD Chip
United States43 participantsStarted 2023-09-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 me…