Clinical Performance Evaluation of T-TAS 01 PL Chip

Healthy Clinical Trial

Official title:

Clinical Performance Evaluation of T-TAS 01 PL Chip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621020
• Other study ID #: TQPL-RD-121-1
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: February 14, 2020

Study information

• Verified date: February 2020
• Source: Hikari Dx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Blood Platelet Disorders
• Congenital Platelets Abnormality
• Healthy
• Platelet Dysfunction
• Von Willebrand Diseases

Intervention

Diagnostic Test:
• T-TAS 01 PL Chip
Flow chamber microchip system specific for measuring primary hemostatic ability
• PFA-100 Col/Epi and Col/ADP
System for measuring platelet dysfunction

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Hikari Dx, Inc.	Fujimori Kogyo Co., Ltd.

Countries where clinical trial is conducted

United States,  France, 

Outcome

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