COMPLETED

T-TAS® wS Method Comparison

Conditions

Antiplatelet Therapy Healthy Donors Von Willebrand Disease (VWD)T-TAS Primary hemostasis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study involves the collection of blood samples and measurement with the T-TAS PL assay to compare the performance of the T-TAS wS instrument to the T-TAS 01 instrument

Official Title

T-TAS® wS Method Comparison

Quick Facts

Study Start:2024-08-21

Study Completion:2025-07-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06710262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion Criteria

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

* 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.

Contacts and Locations

Study Locations (Sites)

University of Florida Health Jacksonville

Jacksonville, Florida, 32209

United States

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

United States

Collaborators and Investigators

Sponsor: Hikari Dx, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-21

Study Completion Date2025-07-14

Study Record Updates

Study Start Date2024-08-21

Study Completion Date2025-07-14

Terms related to this study

Keywords Provided by Researchers

T-TAS
Primary hemostasis

Additional Relevant MeSH Terms

Antiplatelet Therapy
Healthy Donors
Von Willebrand Disease (VWD)