Clinical trial NCT03621020: Clinical Performance Evaluation of T-TAS 01 PL Chip
Official title: Clinical Performance Evaluation of T-TAS 01 PL Chip
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Dysfunction
Von Willebrand Diseases
Healthy
Congenital Platelets Abnormality
Lead sponsor: Hikari Dx, Inc.
Sponsor class: OTHER
Collaborators: name: Fujimori Kogyo Co., Ltd.
First posted: 2018-08-08
Enrollment: 307
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ostensibly healthy subjects without primary hemostasis abnormalities, e.g. a "healthy platelet" normal control population Subjects taking 81+ mg daily aspirin Subjects taking dual antiplatelet therapy Subjects with von Willebrand disease (vWD) Subjects with Glanzmann's thrombasthenia

Brief summary: This study will measure primary hemostatic ability using the T-TAS 01 System with PL chip, with a comparison to clinical truth.

Detailed description: This study will measure primary hemostatic ability using the T-TAS 01 System with PL chip, with a comparison to clinical truth. The study will be conducted at 3 locations in the United States and will enroll approximately 335 subjects. The following subject populations will be enrolled into the study (expected enrollment numbers indicated in parentheses):

* Ostensibly healthy subjects without primary hemostasis abnormalities, e.g. a "healthy platelet" normal control population (N = 150)
* Subjects taking 81+ mg daily aspirin (N = 81)
* Subjects taking dual antiplatelet therapy (N = 51)
* Subjects with von Willebrand disease (vWD; N = 47)
* Subjects with Glanzmann's thrombasthenia (N = 5)

Subjects may be recruited either prospectively or based on their simultaneous participation in other studies involving blood collection, provided that the enrollment criteria. Blood samples will be collected after enrollment and subject participation will be complete after blood samples are collected and all necessary information is collected to complete the case report form (CRF). Blood sample testing with T-TAS 01 will occur locally at each investigational site. Blood sample testing for clinical truth assessment may be tested either locally or remotely, depending on the local availability of the various tests used for determining clinical truth.

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.

Primary outcomes:
measure: Sensitivity and specificity for detecting defects in primary hemostasis
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Lutherville
country: United States
facility: Inova Cardiology Baltimore
state: Maryland
city: Falls Church
country: United States
facility: Inova Heart and Vascular Institute
state: Virginia
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
state: CA
Study officials:
affiliation: Hikari Dx, Inc.
name: Jeffrey Dahlen, Ph.D.
role: STUDY_DIRECTOR
References: