ThrombocytopeniaNCT06087198
Clinical Performance Evaluation of T-TAS®01 HD Chip
An observational study of Thrombocytopenia, run by Hikari Dx, Inc. at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- T-TAS 01 HD Assay
- How many people
- 43 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Sep 2023to 30 Jun 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- Males and females age 18 years or older.
- Able and willing to provide written informed consent.
- Males and females age 18 years or older.
- Known thrombocytopenia, which may be attributed to any of the following:
- Immune thrombocytopenia (ITP)
- Lupus
Show all 19Show fewer
- 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
Who cannot join
- 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).
Show all 26Show fewer
- 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
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
University of Colorado Anschutz Medical Campus
Denver, Colorado, 80217
Duke University
Durham, North Carolina, 27710
University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198
San Francisco General Hospital
San Francisco, California, 94112
About this study
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.
Read the 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.
- Conditions
- Thrombocytopenia
- Being tested
- T-TAS 01 HD Assay
- Keywords
- Thrombogenicity, Platelet transfusion, In vitro diagnostic, Bleeding risk
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-TAS 01 HD AssayDiagnostic test
Disposable flow chamber microchip containing thrombogenic path to facilitate thrombus formation and occlusion
| Study group | Role | What they receive |
|---|---|---|
| Healthy Donors | Ostensibly healthy subjects with a normal platelet count and without a history of hemostasis abnormalities, for establishing expected values for quality control Receives: Diagnostic Test: T-TAS 01 HD Assay | |
| 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 Receives: Diagnostic Test: T-TAS 01 HD Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline thrombogenicity
Proportion of T-TAS 01 HD area under the curve (AUC) < 700
Measured: Baseline
Improvement in thrombogenicity
Difference in proportion of T-TAS 01 HD AUC < 700 between pre-transfusion and post-transfusion measurements
Measured: Day 1 after platelet transfusion
Secondary outcomes (4)
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
Measured: 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
Measured: Day 1 after platelet transfusion
Comparison of pre-and post-transfusion thrombogenicity
Quantitative comparison of TEG results before and after platelet transfusion
Measured: 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
Measured: Day 1 after platelet transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start25 Sep 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hikari Dx, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Fujimori Kogyo Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jeffrey Dahlen, Ph.D., Study director, Hikari Dx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087198
- Sponsor's protocol ID
- GE-0035
- Status last verified
- Jul 2025
- First submitted
- 11 Oct 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of T-TAS®01 HD Chip
- ClinicalTrials.gov ID
- NCT06087198
- Acronym / sponsor ID
- GE-0035
- Conditions
- Thrombocytopenia
- Keywords
- Thrombogenicity, Platelet transfusion, In vitro diagnostic, Bleeding risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hikari Dx, Inc.University, hospital or other
- Collaborators
- Fujimori Kogyo Co., Ltd.
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Donors | – | Diagnostic Test: T-TAS 01 HD AssayOstensibly healthy subjects with a normal platelet count and without a history of hemostasis abnormalities, for establishing expected values for quality control |
| Thrombocytopenia Patients | – | Diagnostic Test: T-TAS 01 HD AssaySubjects with thrombocytopenia who are planned to receive a platelet transfusion who have pre-transfusion and post-transfusion blood samples collected for testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (19 listed)
- Males and females age 18 years or older.
- Able and willing to provide written informed consent.
- Males and females age 18 years or older.
- Known thrombocytopenia, which may be attributed to any of the following:
- Immune thrombocytopenia (ITP)
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-TAS 01 HD AssayDisposable flow chamber microchip containing thrombogenic path to facilitate thrombus formation and occlusion | Diagnostic test | Healthy Donors, Thrombocytopenia Patients |
Primary outcome
Baseline thrombogenicity
Time frame: Baseline
Proportion of T-TAS 01 HD area under the curve (AUC) < 700
Improvement in thrombogenicity
Time frame: Day 1 after platelet transfusion
Difference in proportion of T-TAS 01 HD AUC < 700 between pre-transfusion and post-transfusion measurements
4 secondary outcomes
Correlation with bleeding risk
Time frame: Day 1 after transfusion
Comparison of pre-and post-transfusion thrombogenicity
Time frame: Day 1 after platelet transfusion
Comparison of pre-and post-transfusion thrombogenicity
Time frame: Day 1 after platelet transfusion
Prediction of future platelet transfusions
Time frame: Day 1 after platelet transfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Thrombocytopenia
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 3
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Dahlen, Ph.D. study director
Hikari Dx, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by Hikari Dx, Inc. at 6 sites in United States.
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 19 inclusion and 26 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 28 Jul 2025. 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. 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?
Baseline thrombogenicity (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2025.