Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion

NCT ID: NCT02302365

Last Updated: 2018-07-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-07-31

Brief Summary

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This study is a multicenter, retrospective data collection of routine clinical use with the Spectra Optia® apheresis system for white blood cell depletion.

Detailed Description

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The goal of this study is to gather a broader knowledge and information from routine clinical use on the performance and safety of white blood cell depletion procedures with the Spectra Optia® apheresis system.

In order to do so, retrospective data on white blood cell depletion procedures with the Spectra Optia® apheresis system done in routine use in 3 different centers will be collected and analyzed.

Conditions

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Leukocytosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Spectra Optia® Apheresis System

White Blood Cell Depletion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients having received a minimum of 1 white blood cell depletion procedure via the Spectra Optia Apheresis System

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Terumo BCT

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isobelle Galeon, MD, MPH, MSCS

Role: STUDY_DIRECTOR

Medical Monitor, Clinical Safety

Locations

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UZ Gasthuisberg

Leuven, , Belgium

Site Status

Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden-Württemberg-Hessen gGmbH, Johann-Wolfgang-Goethe-University Hospital

Frankfurt am Main, , Germany

Site Status

Szent Istvan and Szent Laszlo Hospital of Budapest

Budapest, , Hungary

Site Status

Countries

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Belgium Germany Hungary

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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CTS-5043

Identifier Type: -

Identifier Source: org_study_id

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