CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
CPP +1 morebiological
Likely dose
CPP 20 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02078284
NCT02078284Phase 1Completed
CompareCT.gov

Dose Escalation Study Evaluating the Safety of Dimethyl Sulfoxide Cryopreserved Platelets Compared With Liquid Stored Platelets in Patients With Uncontrolled Bleeding

U.S. Army Medical Research and Development Command·interventional·Posted Mar 5, 2014·Updated May 20, 2021

In Brief

A Phase 1 clinical trial evaluating CPP and LSP for Thrombocytopenia. Completed, enrolled 28 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombocytopenia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 5, 2014
Enrollment StartNov 5, 2014
Primary CompletionJul 1, 2016
Study CompletionJul 17, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.3 years ago

Interventions

CPPbiological

One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.

LSPbiological