Clinical Performance Evaluation of T-TAS®01 HD Chip

The study is being conducted to validate the clinical performance of the T-TAS 01 HD assay for measurement of thrombogenicity in patients with thrombocytopenia receiving a platelet transfusion.

Study Overview

• Status: Recruiting
• Conditions: Thrombocytopenia
• Intervention / Treatment: Diagnostic test: T-TAS 01 HD Assay

Detailed Description

This study will measure the improvement in thrombogenicity following platelet transfusion in patients with thrombocytopenia, using the T-TAS 01 HD assay, with a comparison with clinical truth, defined as the confirmation of increased platelet count attributed to platelet transfusion. The study will be conducted at a minimum of 3 locations in the United States and will enroll up to 90 subjects with thrombocytopenia and 50 healthy control subjects. The following subject populations will be enrolled into the study (enrollment numbers indicated in parentheses):

• Ostensibly healthy subjects with a normal platelet count and without a history of hemostasis abnormalities, for establishing expected values for quality control (N = up to 50)
• Subjects with thrombocytopenia who are planned to receive a platelet transfusion who have pre-transfusion and post-transfusion blood samples collected for testing (N = 50; up to 90 will be enrolled in the event that some subjects do not receive platelet transfusions after enrollment) Subjects will be recruited prospectively, and informed consent will be obtained after confirmation that the enrollment criteria described in Section 5a are satisfied. Blood samples will be collected after enrollment, and subject participation will be complete after all blood samples are collected and all necessary information is collected to complete the case report form (CRF). Blood sample testing with the T-TAS 01 and thromboelastography (TEG) assays will occur locally at each investigational site. Other required laboratory measurements (i.e. CBC) will be performed either locally or remotely, depending on the local availability.

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Jeffrey Dahlen, Ph.D.; Phone Number: 619-742-0203; Email: jeff@hikaridx.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94112
      • Recruiting
      • San Francisco General Hospital
      • Contact: Jeffrey Dahlen, Ph.D.
  • Colorado
    • Denver, Colorado, United States, 80217
      • Not yet recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Jeffrey Dahlen, Ph.D.
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Recruiting
      • Sinai Hospital of Baltimore
      • Contact: Jeffrey Dahlen, Ph.D.
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Jeffrey Dahlen, Ph.D.
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Not yet recruiting
      • Duke University
      • Contact: Jeffrey Dahlen, Ph.D.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Not yet recruiting
      • University of Oklahoma
      • Contact: Jeffrey Dahlen, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

• Ostensibly healthy subjects with a normal platelet count and without a history of hemostasis abnormalities, for establishing expected values for quality control (N = up to 50)
• Subjects with thrombocytopenia who are planned to receive a platelet transfusion who have pre-transfusion and post-transfusion blood samples collected for testing (N = 50; up to 90 will be enrolled in the event that some subjects do not receive platelet transfusions after enrollment)

Description

Healthy Donors:

Inclusion Criteria:

• Males and females age 18 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 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) that inhibit COX-1 such as rofecoxib, etc. within the past 14 days, unless confirmed to not inhibit platelet activity (such as celecoxib).
• History of anemia.
• Known thrombocytopenia (platelet count < 100,000/μL).
• Significant renal dysfunction (eGFR < 30 mL/min/1.73 m2) 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 clinically significant bleeding requiring physician consultation or visit to healthcare facility.
• 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.

Thrombocytopenia Patients

Inclusion Criteria:

• Males and females age 18 years or older.
• Known thrombocytopenia, which may be attributed to any of the following:
• Immune thrombocytopenia (ITP)
• Lupus
• Rheumatoid arthritis
• Aplastic anemia
• Thrombotic thrombocytopenic purpura (TTP)
• Disseminated intravascular coagulation (DIC)
• Heparin induced thrombocytopenia (HIT)
• Vaccine-induced thrombotic thrombocytopenia (VITT)
• Infection
• Surgery
• Cancer
• Other etiologies including trauma, portal hypertension, liver disease, etc.
• Platelet count < 90,000/μL, confirmed by pre-transfusion CBC
• Planned platelet transfusion.
• Able and willing to provide written informed consent

Exclusion Criteria:

• Use of antiplatelet therapy within the past 14 days, e.g. aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol, abciximab, eptifibatide within the past 14 days.
• Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) known to affect platelet function such as rofecoxib, etc. within the past 14 days, unless confirmed to not inhibit platelet activity (such as celecoxib).
• Surgical procedure on the same day as the baseline blood sample collection and testing
• Surgical procedure after baseline sample collection and testing, and prior to completion of all post-transfusion blood sample collection and testing
• Significant renal dysfunction (eGFR < 30 mL/min/1.73 m2) or dialysis.
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Donors; Ostensibly healthy subjects with a normal platelet count and without a history of hemostasis abnormalities, for establishing expected values for quality control	Diagnostic test: T-TAS 01 HD Assay; Disposable flow chamber microchip containing thrombogenic path to facilitate thrombus formation and occlusion
Thrombocytopenia Patients; Subjects with thrombocytopenia who are planned to receive a platelet transfusion who have pre-transfusion and post-transfusion blood samples collected for testing	Diagnostic test: T-TAS 01 HD Assay; Disposable flow chamber microchip containing thrombogenic path to facilitate thrombus formation and occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline thrombogenicity	Proportion of T-TAS 01 HD area under the curve (AUC) < 700	Baseline
Improvement in thrombogenicity	Difference in proportion of T-TAS 01 HD AUC < 700 between pre-transfusion and post-transfusion measurements	Day 1 after platelet transfusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with bleeding risk	Comparison of T-TAS 01 HD AUC results stratified by major and minor bleeding according to the modified WHO Bleeding Scale	Day 1 after transfusion
Comparison of pre-and post-transfusion thrombogenicity	Quantitative comparison of T-TAS 01 HD AUC results before and after platelet transfusion	Day 1 after platelet transfusion
Comparison of pre-and post-transfusion thrombogenicity	Quantitative comparison of TEG results before and after platelet transfusion	Day 1 after platelet transfusion
Prediction of future platelet transfusions	Quantitative and qualitative comparison of post-transfusion T-TAS 01 HD results with the number of additional platelet transfusions within the following 14 days	Day 1 after platelet transfusion

Collaborators and Investigators

• Sponsor: Hikari Dx, Inc.
• Collaborators: Fujimori Kogyo Co., Ltd.
• Investigators: Study Director: Jeffrey Dahlen, Ph.D., Hikari Dx, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Bleeding risk; Thrombogenicity; Platelet transfusion; In vitro diagnostic
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: GE-0035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No