Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion

Study 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.

Official Title
-----------------
Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion

Conditions
-----------------
Leukocytosis

Intervention / Treatment
-----------------
* Device: Spectra Optia® Apheresis System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having received a minimum of 1 white blood cell depletion procedure via the Spectra Optia Apheresis System Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Spectra Optia® Apheresis System|White Blood Cell Depletion|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure | Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100% | immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure | 
| Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia. | 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) | immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure | 
| Adverse Events | 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. | Participants were followed for the duration of the procedure and for up to 24 hours after the procedure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
white blood cell depletion, apheresis