drugset / Trial / NCT02078284
Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is to evaluate the safety of intravenous (IV) infusion of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) in participants with World Health Organization (WHO) Grade 2 bleed in spite of receiving a transfusion of liquid stored platelets (LSP) in the past 48 hours by collecting adverse events (AEs) and by evaluating coagulation-related parameters to assess the evidence of any thrombotic events after CPP or LSP transfusion.
Timeline
- Start
- 2014-11-05
- Primary completion
- 2016-07
- Completion
- 2016-07-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) | Unknown | 0.5 unknown | Intravenous |
| Subject | dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) | Unknown | 1 unknown | Intravenous |
| Subject | dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) | Unknown | 2 unknown | Intravenous |
| Subject | dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) | Unknown | 3 unknown | Intravenous |
| Comparator | liquid stored platelets (LSP) | Unknown | 1 unknown | Intravenous |