Clinical Performance Evaluation of T-TAS 01 PL Chip

NCT ID: NCT03621020

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 307 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-02-14

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.

Conditions

Platelet Dysfunction; Von Willebrand Diseases; Healthy; Congenital Platelets Abnormality

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy controls

Subjects not taking medications with antiplatelet effects, without evidence of vWD or history of congenital platelet abnormalities, without history of significant bleeding.

T-TAS 01 PL Chip

Intervention Type: DIAGNOSTIC_TEST

Flow chamber microchip system specific for measuring primary hemostatic ability

PFA-100 Col/Epi and Col/ADP

Intervention Type: DIAGNOSTIC_TEST

System for measuring platelet dysfunction

Aspirin monotherapy

Subjects taking 81+ mg daily aspirin and no additional medications with antiplatelet effects, without evidence of vWD or history of congenital platelet abnormalities, without history of significant bleeding.

T-TAS 01 PL Chip

Intervention Type: DIAGNOSTIC_TEST

Flow chamber microchip system specific for measuring primary hemostatic ability

PFA-100 Col/Epi and Col/ADP

Intervention Type: DIAGNOSTIC_TEST

System for measuring platelet dysfunction

von Willebrand Disease

Subjects diagnosed with vWD (all types except Type 2N), not taking medications with antiplatelet effects, and history of clinically significant bleeding.

T-TAS 01 PL Chip

Intervention Type: DIAGNOSTIC_TEST

Flow chamber microchip system specific for measuring primary hemostatic ability

PFA-100 Col/Epi and Col/ADP

Intervention Type: DIAGNOSTIC_TEST

System for measuring platelet dysfunction

Glanzmann's Thrombasthenia

Subjects diagnosed with Glanzmann's Thrombasthenia, not taking medications with antiplatelet effects, and history of clinically significant bleeding.

T-TAS 01 PL Chip

Intervention Type: DIAGNOSTIC_TEST

Flow chamber microchip system specific for measuring primary hemostatic ability

PFA-100 Col/Epi and Col/ADP

Intervention Type: DIAGNOSTIC_TEST

System for measuring platelet dysfunction

Dual antiplatelet therapy (DAPT)

Subjects taking 81 mg daily aspirin and either 75 mg daily clopidogrel, 10 mg daily prasugrel, or 180 mg daily ticagrelor

T-TAS 01 PL Chip

Intervention Type: DIAGNOSTIC_TEST

Flow chamber microchip system specific for measuring primary hemostatic ability

Interventions

T-TAS 01 PL Chip

Flow chamber microchip system specific for measuring primary hemostatic ability

Intervention Type: DIAGNOSTIC_TEST

PFA-100 Col/Epi and Col/ADP

System for measuring platelet dysfunction

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Males and females age 21 years or older.

• 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

• 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

• Males and females age 21 years or older.
• Prior diagnosis of Glanzmann's thrombasthenia
• History of bleeding.

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:

• 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.

• 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:

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fujimori Kogyo Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Hikari Dx, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Dahlen, Ph.D.

Role: STUDY_DIRECTOR

Hikari Dx, Inc.

Locations

San Francisco General Hospital

San Francisco, California, United States

University of Iowa

Iowa City, Iowa, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Inova Cardiology Baltimore

Lutherville, Maryland, United States

Inova Heart and Vascular Institute

Falls Church, Virginia, United States

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, CA, France

Countries

United States; France

Other Identifiers

TQPL-RD-121-1

Identifier Type: -

Identifier Source: org_study_id