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.
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
43
Disposable flow chamber microchip containing thrombogenic path to facilitate thrombus formation and occlusion
San Francisco General Hospital
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Denver, Colorado, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Baseline thrombogenicity
Proportion of T-TAS 01 HD area under the curve (AUC) \< 700
Time frame: Baseline
Improvement in thrombogenicity
Difference in proportion of T-TAS 01 HD AUC \< 700 between pre-transfusion and post-transfusion measurements
Time frame: Day 1 after platelet transfusion
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
Time frame: 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
Time frame: Day 1 after platelet transfusion
Comparison of pre-and post-transfusion thrombogenicity
Quantitative comparison of TEG results before and after platelet transfusion
Time frame: 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
Time frame: Day 1 after platelet transfusion
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Duke University
Durham, North Carolina, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States