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Mirasol-Treated Platelets - (Pathogen Reduction Extended Storage Study)

NCT01368211 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-06-28

Study results available
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Summary

The PRESS trial is a single-center, two-part, randomized cross-over pilot study in Copenhagen that will evaluate 1) the safety and performance of Mirasol-treated and untreated platelet products stored for 2-4 days and for 7-days in Platelet Additive Solution (PAS) and 2) the correlation between the TEG® parameters and platelet count increments after platelet transfusions in thrombocytopenic subjects.

Conditions

Interventions

BIOLOGICAL

2-4-day-old Mirasol-treated Platelets Transfusion

2-4-day-old Mirasol-treated Platelets Units with: * Platelet yield between 2.4x10e11 and 4.5x10e11 * Plasma carryover of \>32% * Cell count \> 800x103/µL

BIOLOGICAL

2-4-day-old Untreated Platelets Transfusion

2-4-day-old Untreated Platelets Units with: * Platelet yield between 2.4x10e11 and 4.5x10e11 * Plasma carryover of \>32% * Cell count \> 800x103/µL

Sponsors & Collaborators

  • Terumo BCTbio

    lead INDUSTRY

Principal Investigators

  • Pär Johansson, MD · Transfusion Service Rigshospitalet - Dept of Immunology, Copenhagen Denmark

  • Lene Udby, MD · Hematology Service Rigshospitalet, Copenhagen Denmark

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-04-30
Completion
2011-05-31

Countries

  • Denmark

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 NCT01368211 on ClinicalTrials.gov