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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.
Full 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):
Enrollment
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Inclusion and exclusion criteria
Healthy Donors:
Inclusion Criteria:
Exclusion Criteria:
Thrombocytopenia Patients
Inclusion Criteria:
Exclusion Criteria:
140 participants in 2 patient groups
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Central trial contact
Jeffrey Dahlen, Ph.D.
Data sourced from clinicaltrials.gov
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