Comparison of T-TAS instruments for blood sample analysis

T-TAS® WS Method Comparison

This study is testing a new blood testing device to see if it works better than an older one for measuring how well blood clots in different groups of people.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Hikari Dx, Inc. (Academic / other)
• Drugs / interventions: abciximab
• Locations: 2 sites (Jacksonville, Florida and 1 other locations)
• Trial ID: NCT06710262 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare the performance of the T-TAS wS instrument against the T-TAS 01 instrument using the T-TAS PL assay. Blood samples will be collected from various subject populations, including healthy donors and individuals on antiplatelet therapy or with von Willebrand disease. The study will enroll up to 120 subjects across at least three locations in the United States. The goal is to evaluate the accuracy and reliability of the new instrument in measuring primary hemostasis.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 21 and older who can provide informed consent.

Not a fit: Patients with recent hospitalization, those on antiplatelet or anticoagulant therapy, or individuals with bleeding disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of blood sample analysis for patients on antiplatelet therapy and those with bleeding disorders.

How similar studies have performed: Other studies have shown promising results in comparing similar blood analysis methods, indicating potential for success in this approach.

Eligibility criteria

Ostensibly Healthy Donors

Inclusion Criteria:

* Males and females age 21 years or older.
* Able and willing to provide written informed consent.

Exclusion Criteria:

* Hospitalization or doctor's visits within prior 30 days, except for routine checkup/physical examination.
* Use of antiplatelet therapy within the past 7 days, e.g. aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol.
* Use of anticoagulant drugs within the past 7 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
* Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) that inhibit COX-1 such as naproxen or ibuprofen within the past 3 days, unless confirmed to not inhibit platelet activity (such as celecoxib).
* 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.
* 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.
* One of the following antiplatelet therapy regimens:
* Aspirin monotherapy:
* 81 mg or higher aspirin daily for 1 or more days
* Dual antiplatelet therapy:
* 81 mg or higher aspirin plus either 1) ≥300 mg clopidogrel loading dose within the prior 5 days followed by 75 mg daily clopidogrel, or 2) 75 mg daily clopidogrel daily for ≥5 days.
* 81 mg or higher aspirin plus either 1) 60 mg prasugrel loading dose within the prior 5 days followed by either 5 or 10 mg daily prasugrel, or 2) 5 or 10 mg daily prasugrel daily for ≥5 days.
* 81 mg aspirin plus either 1) 180 mg ticagrelor loading dose within the prior 5 days followed by 2x90 mg daily ticagrelor, or 2) 2x90 mg daily ticagrelor daily for ≥5 days.
* Able and willing to provide written informed consent.

Exclusion Criteria:

* Use of antiplatelet therapy other than aspirin, clopidogrel, prasugrel, or ticagrelor (e.g. cilostazol, abciximab, eptifibatide) within the past 7 days.
* Use of anticoagulant drugs within the past 7 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
* 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.

Von Willebrand Disease Subjects

Inclusion Criteria:

* Males and females age 21 years or older.
* Prior diagnosis of von Willebrand disease type 1, 2A, 2B, 2M, or 3
* Able and willing to provide written informed consent.

Exclusion Criteria:

* Prior diagnosis of von Willebrand disease type 2N
* Use of antiplatelet therapy besides aspirin 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) that inhibit COX-1 such as naproxen or ibuprofen within the past 7 days, unless confirmed to not inhibit platelet activity (such as celecoxib).
* Significant renal dysfunction or dialysis.
* Known thrombocytopenia (platelet count \< 100,000/μL).
* 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.

Where this trial is running

Jacksonville, Florida and 1 other locations

• University of Florida Health Jacksonville — Jacksonville, Florida, United States (Recruiting)
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Jeffrey Dahlen, Ph.D.

Conditions Antiplatelet Therapy; Healthy Donors; Von Willebrand Disease; T-TAS; Primary hemostasis