drugset / Trial / NCT02078284

Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets

NCT02078284 ↗

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

EvaluationDrugModalityDoseRoute
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

Indications