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Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products

NCT00263809 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2009-10-07

No results posted yet for this study

Summary

The primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device (test product) versus untreated (reference product).

Conditions

Interventions

DEVICE

Pathogen Reduction Technology

Sponsors & Collaborators

  • Terumo BCTbio

    lead INDUSTRY

Principal Investigators

  • Jean-Pierre Cazenave, MD · Director - EFS Alsace - France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • France

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 NCT00263809 on ClinicalTrials.gov