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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02302365 |
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Date of registration:
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18/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion
WBCD |
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Scientific title:
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Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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43 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02302365 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Belgium
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Germany
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Hungary
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Contacts
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Name:
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Isobelle Galeon, MD, MPH, MSCS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Monitor, Clinical Safety |
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Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Leukocytosis
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Intervention(s)
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Device: Spectra Optia® Apheresis System
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Primary Outcome(s)
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Adverse Events
[Time Frame: Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.]
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Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure
[Time Frame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure]
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Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.
[Time Frame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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