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8110 Gatehouse Road, Falls Church, VA 22042

Clinical Performance Evaluation of T-TAS®01 PL chip

General Information

Age Group

Adult

Status

Active

Protocol Number

TQPL-RD-121-1

Background Information

The purpose of this study is to test an investigational device, the T-TAS 01 System, designed to measure blood clotting. “Investigational” means that this device has not been approved by the United States Food and Drug Administration (FDA).

How the study device measures blood clotting will be compared to another device that is already on the market to test blood clotting. To perform the necessary evaluations, blood specimens will be collected via venipuncture from the following four (4) different groups of people.

  • Healthy subjects
  • Subjects taking 325 mg/day aspirin
  • Subjects with von Willebrand disease
  • Subjects with Glanzmann’s thrombasthenia

Offered At

Inova Center for Thrombosis Research and Drug Development,
Inova Heart and Vascular Institute
3300 Gallows Road
Falls Church, VA 22042

Eligibility Information

  • Males and females age 21 years or older
  • Able and willing to provide written informed consent

Ineligibility Information

  • Abnormal results from assays used to establish clinical truth (retrospective exclusion)
  • 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) such as celecoxib, rofecoxib, etc. within the past 14 days
  • 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
  • History of bleeding, with Bleeding Score ≥ 5 (Tosetto J Thromb Haemost 2006). See Appendix A. Scores will be assigned based on health history according to the following categories:
    • Epistaxis
    • Cutaneous bleeding
    • Bleeding from minor wounds
    • Bleeding from oral cavity
    • Gastrointestinal bleeding
    • Bleeding from tooth extraction
    • Surgical bleeding
    • Menorrhagia
    • Post-partum hemorrhage
    • Muscle hematoma
    • Hemarthrosis
    • Central nervous system bleeding
  • 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