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Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets

NCT02078284 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-05-20

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

CPP

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.

BIOLOGICAL

LSP

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Sherrill J Slichter, MD · Bloodworks

  • Terry B Gernsheimer, MD · University of Washington, Division of Hematology

  • Zbigniew Szczepiorkowski, MD, PhD · Center for Transfusion Medicine Research, Lebanon, NH

  • Jose A Cancelas-Perez, MD, PhD · Hoxworth Blood Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-05
Primary Completion
2016-07-31
Completion
2016-07-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02078284 on ClinicalTrials.gov