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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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19 October 2017 |
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Main ID: |
NCT02308787 |
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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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Retrospective Data Collection of Routine Use With Spectra Optia® for Platelet Depletions
PLTD |
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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 Platelet Depletion Procedures. |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02308787 |
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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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N/A
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Countries of recruitment
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Denmark
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Hungary
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Contacts
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Name:
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Raymond P Goodrich, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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VP, Scientific and Clinical Affairs; Chief Science Officer-BBT |
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Key inclusion & exclusion 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:
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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Thrombocythemia
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Myeloproliferative Disease
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Thrombocytosis
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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: during the apheresis procedure (from the moment the patient is connected until he is disconnected from the device) and device or procedure related adverse events until discharge from Apheresis Unit (On average, half hour after end of procedure).]
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Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia.
[Time Frame: on average this will be within 15 minutes after the end of the procedure]
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Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure
[Time Frame: 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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