Retrospective Data Collection of Routine Use With Spectra Optia® for Platelet Depletions

NCT ID: NCT02308787

Last Updated: 2016-06-15

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

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-05-31

Brief Summary

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Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia® Apheresis System for Platelet Depletion Procedures.

Detailed Description

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This is a multicenter, retrospective data collection to evaluate the in routine use performance and safety of platelet depletions performed via the Spectra Optia system. Data collection will include procedures in 2- 3 different centers in Europe done between November 2011 and April 2014.

Conditions

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Thrombocythemia Myeloproliferative Disease Thrombocytosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Spectra Optia Apheresis System

Platelet Depletion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients having received a minimum of one platelet depletion procedure via the Spectra Optia system.
* Availability of complete blood count results prior to starting and after completing the platelet depletion procedure via the Spectra Optia 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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Raymond P Goodrich, PhD

Role: STUDY_DIRECTOR

VP, Scientific and Clinical Affairs; Chief Science Officer-BBT

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

University of Pécs

Pécs, , Hungary

Site Status

Countries

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Denmark Hungary

Other Identifiers

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CTS-5052

Identifier Type: -

Identifier Source: org_study_id

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