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Platelet DysfunctionNCT03621020

Clinical Performance Evaluation of T-TAS 01 PL Chip

An observational study of Platelet Dysfunction and Von Willebrand Diseases, run by Hikari Dx, Inc. at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
What is being tested?
T-TAS 01 PL Chip and PFA-100 Col/Epi and Col/ADP
How many people
307 participants
Where
6 sitesin 2 countries
Study dates
1 Sep 2018to 14 Feb 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.
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  • 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:
  • 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:
  • 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.

Who cannot join

None listed.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States5 sites

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Inova Heart and Vascular Institute

    Falls Church, Virginia, 22042

  • University of Iowa

    Iowa City, Iowa, 52242

  • Inova Cardiology Baltimore

    Lutherville, Maryland, 21093

  • San Francisco General Hospital

    San Francisco, California, 94112

Other trials in United States

France1 site

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, CA, 92131

Other trials in France

About this study

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

Read the 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.

Being tested
T-TAS 01 PL Chip, PFA-100 Col/Epi and Col/ADP
Medical subject headings
von Willebrand Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T-TAS 01 PL ChipDiagnostic test

    Flow chamber microchip system specific for measuring primary hemostatic ability

  • PFA-100 Col/Epi and Col/ADPDiagnostic test

    System for measuring platelet dysfunction

Study groups in NCT03621020
Study groupRoleWhat they receive
Healthy controlsSubjects not taking medications with antiplatelet effects, without evidence of vWD or history of congenital platelet abnormalities, without history of significant bleeding.
Receives: Diagnostic Test: T-TAS 01 PL Chip; Diagnostic Test: PFA-100 Col/Epi and Col/ADP
Aspirin monotherapySubjects 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.
Receives: Diagnostic Test: T-TAS 01 PL Chip; Diagnostic Test: PFA-100 Col/Epi and Col/ADP
von Willebrand DiseaseSubjects diagnosed with vWD (all types except Type 2N), not taking medications with antiplatelet effects, and history of clinically significant bleeding.
Receives: Diagnostic Test: T-TAS 01 PL Chip; Diagnostic Test: PFA-100 Col/Epi and Col/ADP
Glanzmann's ThrombastheniaSubjects diagnosed with Glanzmann's Thrombasthenia, not taking medications with antiplatelet effects, and history of clinically significant bleeding.
Receives: Diagnostic Test: T-TAS 01 PL Chip; Diagnostic Test: PFA-100 Col/Epi and Col/ADP
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
Receives: Diagnostic Test: T-TAS 01 PL Chip

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity and specificity for detecting defects in primary hemostasis

    Sensitivity and specificity of the T-TAS 01 PL chip assay against clinical truth

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2018
  2. Study start1 Sep 2018
  3. Primary completion14 Feb 2020
  4. Study completion14 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03621020
Sponsor's protocol ID
TQPL-RD-121-1
Status last verified
Feb 2020
First submitted
5 Aug 2018
Last updated
18 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Platelet Dysfunction and Von Willebrand Diseases, run by Hikari Dx, Inc. at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 88 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and specificity for detecting defects in primary hemostasis (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03621020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.

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