- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02302365
Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion (WBCD)
Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- UZ Gasthuisberg
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Frankfurt/Main, Germany, 60528
- Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden-Württemberg-Hessen gGmbH, Johann-Wolfgang-Goethe-University Hospital
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Budapest, Hungary, 1097
- Szent Istvan and Szent Laszlo Hospital of Budapest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients having received a minimum of 1 white blood cell depletion procedure via the Spectra Optia Apheresis System
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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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Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100%
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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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Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume)
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immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure
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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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Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure.
Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure.
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Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pre-procedure WBC Count
Time Frame: Prior to Each Spectra Optia Apheresis Procedure
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Pre-procedure WBC count
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Prior to Each Spectra Optia Apheresis Procedure
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Post-procedure WBC Count
Time Frame: Following apheresis procedure
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Post-procedure WBC count
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Following apheresis procedure
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Patient's Platelet Count Pre-depletion Procedure
Time Frame: Prior to Each Spectra Optia Apheresis Procedure
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Patient's platelet count pre-depletion procedure
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Prior to Each Spectra Optia Apheresis Procedure
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Patient's Platelet Count Post-depletion Procedure
Time Frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
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Patient's platelet count post-depletion procedure
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Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
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Whole Blood Processed (mL)
Time Frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
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Volume of patient's blood processed in mL during the apheresis procedure
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Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
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Whole Blood Flow mL/Min
Time Frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
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Whole Blood Flow in mL/min measured during the white blood cell depletion procedure
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Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
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Procedure Duration
Time Frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
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The duration of the WBCD procedure measured in minutes
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Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
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Platelet Change (% Change)
Time Frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
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% change in patient's pre and post-depletion procedure platelet counts
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Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
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Waste Bag Volume
Time Frame: Post each Spectra Optia Apheresis Procedure
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Volume of the depletion product
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Post each Spectra Optia Apheresis Procedure
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Isobelle Galeon, MD, MPH, MSCS, Medical Monitor, Clinical Safety
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTS-5043
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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