A Prospective, Multicenter, Randomized, Open-Label, Phase 2, Parallel, Dose Ranging Multidose Study Of Thrombosomes® Vs Liquid Stored Platelets (Lsp) In Bleeding Thrombocytopenic Patients
Posted Date: Apr 18, 2024
- Investigator: Jose Cancelas
- Type of Study: Drug
This is a prospective, multicenter, randomized, open-label, Phase 2, parallel, dose ranging multidose study of Thrombosomes versus LSP in bleeding patients with TCP as manifested by a platelet count = 70,000 platelets/µL blood, and also having one or more of the following: (1) confirmed primary bone marrow disorders; (2) undergoing chemotherapy, immunotherapy, radiation therapy or hematopoietic stem cell transplantation; or (3) refractory response to platelet concentrate transfusion. Patients must have a WHO Bleeding Score of 2 or 3 excluding WHO Bleeding Score of 2 due solely to lumbar puncture, retinal bleeding or GI bleeding or WHO Bleeding Score of 3 due solely to lumbar puncture. Adult (=18 years) patients will be included in this trial.
Criteria:
1. Adults (=18 Years) With Tcp As Defined By Both (A) And (B): A) A Platelet Count = 70,000 Platelets/Μl Blood B) Any One Or More Of (1–3): 1) Confirmed Diagnosis Of Hematologic Malignancy, Myeloproliferative Disorder, Myelodysplastic Syndrome, Or Aplasia 2) Undergoing Chemotherapy, Immunotherapy, Radiation Therapy Or Hematopoietic Stem Cell Transplantation 3) 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) 2. Who Bleeding Score Of 2 Or 3 3. Able To Provide Informed Consent Directly Or Through Legally Authorized Representative, And Comply With Treatment And Monitoring 4. Negative Pregnancy Test For Women Of Childbearing Potential
Keywords:
Lyophilized Platelets, Transfusion, Thrombocytopenic Hem/Onc Patients
For More Information:
Jose A Cancelas
15133760250
jose.cancelas@uc.edu