Pathogen Reduction Evaluation & Predictive Analytical Rating Score

NCT02783313 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 567

Last updated 2018-08-23

No results posted yet for this study

Summary

The objective of this study is to determine if pooled buffy coat-derived pathogen reduced plasma-stored platelet concentrates are non-inferior compared to plasma-stored platelet concentrates in terms of WHO bleeding complications in hemato-oncological patients with thrombocytopenia.

Conditions

Interventions

DEVICE

Pathogen reduced plasma-stored platelet concentrates

Platelet concentrates treated with the Mirasol PRT system (pathogen reduction technology) and stored in plasma.

OTHER

Plasma-stored platelet concentrates

Platelet concentrates stored in plasma

Sponsors & Collaborators

  • Terumo BCT

    collaborator INDUSTRY
  • Sanquin Research & Blood Bank Divisions

    lead OTHER

Principal Investigators

  • Jean-Louis Kerkhoffs, MD, PhD · Sanquin Blood Bank

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-17
Primary Completion
2016-04-30
Completion
2016-06-30

Countries

  • Canada
  • Netherlands
  • Norway

Study Locations

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Entities

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 NCT02783313 on ClinicalTrials.gov