Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Leukocytosis
- Sponsor
- Terumo BCT
- Enrollment
- 43
- Locations
- 3
- Primary Endpoint
- Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients having received a minimum of 1 white blood cell depletion procedure via the Spectra Optia Apheresis System
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100%
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
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)
Adverse Events
Time Frame: Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.
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.