Clinical trial: Clinical Performance Evaluation of T-TAS 01 PL Chip (NCT03621020)

Eligibility criteria:
Normal Controls:

        Inclusion Criteria

          -  Males and females age 21 years or older.

          -  Able and willing to provide written informed consent. Exclusion Criteria

          -  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.

        Antiplatelet Therapy Subjects:

        Inclusion Criteria

          -  Males and females age 21 years or older.

          -  Continuous daily ingestion of one of the following antiplatelet therapy regimens:

               -  81 mg or higher aspirin

               -  81 mg or higher aspirin plus 75 mg daily clopidogrel

               -  81 mg or higher aspirin plus 10 mg daily prasugrel

               -  81 mg aspirin plus 180 mg daily ticagrelor

          -  Able and willing to provide written informed consent. Exclusion Criteria

          -  Use of antiplatelet therapy besides aspirin (e.g. clopidogrel, prasugrel, ticagrelor,
             cilostazol, abciximab, eptifibatide) 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) such as celecoxib,
             rofecoxib, etc. within the past 14 days.

          -  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.

        vWD Subjects: Inclusion Criteria

          -  Males and females age 21 years or older.

          -  Prior diagnosis of von Willebrand disease type 1, 2A, 2B, 2M, or 3

          -  History of bleeding, with Bleeding Score ≥ 5, which is 99% specific for vWD (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

          -  Able and willing to provide written informed consent. Exclusion Criteria

          -  Prior diagnosis of von Willebrand disease type 2N

          -  Receiving desmopressin or vWF replacement therapy within the past 2 weeks.

          -  Use of antiplatelet therapy 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) such as celecoxib,
             rofecoxib, etc. within the past 14 days.

          -  Significant renal dysfunction or dialysis.

          -  Known thrombocytopenia (platelet count < 100,000/μL).

          -  Females who are in the last trimester of pregnancy, or are breastfeeding.

          -  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.

        Glanzmann's Thrombasthenia Subjects:

        Inclusion Criteria

          -  Males and females age 21 years or older.

          -  Prior diagnosis of Glanzmann's thrombasthenia

          -  History of bleeding.

          -  Able and willing to provide written informed consent. Exclusion Criteria

          -  Use of antiplatelet therapy 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) such as celecoxib,
             rofecoxib, etc. within the past 14 days.

          -  Significant renal dysfunction or dialysis.

          -  Known thrombocytopenia (platelet count < 100,000/μL).

          -  Females who are in the last trimester of pregnancy, or are breastfeeding.

          -  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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.


Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? 1