Healthy Clinical Trial
Official title:
Clinical Performance Evaluation of T-TAS 01 PL Chip
Verified date | February 2020 |
Source | Hikari Dx, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will measure primary hemostatic ability using the T-TAS 01 System with PL chip, with a comparison to clinical truth.
Status | Completed |
Enrollment | 307 |
Est. completion date | February 14, 2020 |
Est. primary completion date | February 14, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire de Bordeaux | Bordeaux | CA |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Inova Heart and Vascular Institute | Falls Church | Virginia |
United States | University of Iowa | Iowa City | Iowa |
United States | Inova Cardiology Baltimore | Lutherville | Maryland |
United States | San Francisco General Hospital | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Hikari Dx, Inc. | Fujimori Kogyo Co., Ltd. |
United States, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and specificity for detecting defects in primary hemostasis | Sensitivity and specificity of the T-TAS 01 PL chip assay against clinical truth | Baseline |
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