Thrombosomes® in Bleeding Thrombocytopenic Patients Study (NCT04631211) | Clinical Trial Compass
TerminatedPhase 2
Thrombosomes® in Bleeding Thrombocytopenic Patients Study
Stopped: This study was terminated due to loss of funding for this indication from the Biomedical Advanced Research and Development Authority (BARDA) in November 2022.
United States, Israel21 participantsStarted 2021-03-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults (≥18 years) with TCP as defined by BOTH (a) and (b):
✓. a platlet count of ≤ 70,000 platelets/μL blood
âś“. ANY ONE OR MORE of (1-3):
âś“. confirmed diagnosis of hematologic malignancy, myeloproliferative disorder, myelodysplastic syndrome, or aplasia
âś“. 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)
âś“. WHO Bleeding Score of 2 or 3
âś“. Able to provide informed consent directly or through legally authorized representative, and comply with treatment and monitoring
Exclusion criteria
âś•. Any disorder or condition related to any venous thrombosis, embolism, or ischemia within the past 3 months
What they're measuring
1
Primary Efficacy Endpoint
Timeframe: Evaluated at 24 hours post initial infusion