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

Completed

• Conditions: Leukocytosis

• Registration Number: NCT02302365
• Lead Sponsor: Terumo BCT

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-27
• Results First Submitted: 2015-11-12
• Results First Submitted QC: 2016-02-03
• Results First Posted: 2016-03-03
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Patients having received a minimum of 1 white blood cell depletion procedure via the Spectra Optia Apheresis System

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure	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.	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	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.

Trial Locations

Locations (3)

Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden-Württemberg-Hessen gGmbH, Johann-Wolfgang-Goethe-University Hospital; 🇩🇪 Frankfurt/Main, Germany

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

Szent Istvan and Szent Laszlo Hospital of Budapest; 🇭🇺 Budapest, Hungary