A Prospective, Multicenter, Randomized, Open-Label Phase 2, Parallel, Dose Ranging Multidose Study of Thrombosomes® vs Liquid Stored Platelets (LSP) in Bleeding Thrombocytopenic Patients
This prospective, multicenter, randomized, open-label, Phase 2, parallel, dose ranging, multidose trial will enroll patients into 3 Thrombosomes dose groups and 1 control liquid stored platelets (LSP) group in order to evaluate, in a dose-escalation manner, the safety, and impact on bleeding, and the preliminary effect on coagulation measures of increasing doses of allogeneic Thrombosomes in comparison to standard of care, LSP.
• Adults (≥18 years) with TCP as defined by BOTH (a) and (b):
‣ a platlet count of ≤ 70,000 platelets/μL blood
⁃ ANY ONE OR MORE of (1-3):
• confirmed diagnosis of hematologic malignancy, myeloproliferative disorder, myelodysplastic syndrome, or aplasia
∙ undergoing chemotherapy, immunotherapy, radiation therapy or hematopoietic stem cell transplantation
∙ refractory to platelet transfusion defined as two 1-hour CCI of \<5,000 on consecutive transfusions of LSP or as defined by local site policy (Sacher, 2003)
• WHO Bleeding Score of 2 or 3
• Able to provide informed consent directly or through legally authorized representative, and comply with treatment and monitoring
• Negative pregnancy test for women of childbearing potential