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Healthy Donors for Low Platelet Count

N/A
Recruiting
Research Sponsored by Hikari Dx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 after transfusion
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baseline thrombogenicity
Improvement in thrombogenicity
Secondary outcome measures
Comparison of pre-and post-transfusion thrombogenicity
Correlation with bleeding risk
Prediction of future platelet transfusions

Trial Design

2Treatment groups
Experimental Treatment
Group I: Thrombocytopenia PatientsExperimental Treatment1 Intervention
Subjects with thrombocytopenia who are planned to receive a platelet transfusion who have pre-transfusion and post-transfusion blood samples collected for testing
Group II: Healthy DonorsExperimental Treatment1 Intervention
Ostensibly healthy subjects with a normal platelet count and without a history of hemostasis abnormalities, for establishing expected values for quality control

Find a Location

Who is running the clinical trial?

Hikari Dx, Inc.Lead Sponsor
2 Previous Clinical Trials
757 Total Patients Enrolled
Fujimori Kogyo Co., Ltd.UNKNOWN
1 Previous Clinical Trials
307 Total Patients Enrolled
Jeffrey Dahlen, Ph.D.Study DirectorHikari Dx, Inc.
1 Previous Clinical Trials
307 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
University of Colorado Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Clinical Performance Evaluation of T-TAS®01 HD Chip
2023. "Clinical Performance Evaluation of T-TAS®01 HD Chip". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06087198.
All > Omaha
~88 spots leftby Apr 2025
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