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

This study is a multicenter, retrospective data collection of routine clinical use with the Spectra Optia® apheresis system for white blood cell depletion.

Study Overview

• Status: Completed
• Conditions: Leukocytosis
• Intervention / Treatment: Device: Spectra Optia® Apheresis System

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: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Uz Gasthuisberg
• Germany
  • 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
• Hungary
  • Budapest, Hungary, 1097
    • Szent Istvan and Szent Laszlo Hospital of Budapest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone white blood cell depletion via the Spectra Optia Apheresis System which is likely to include patients with severe leukocytosis in acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, or in chronic myelogenous leukemia) or to prevent tumor lysis syndrome.

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?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-procedure WBC Count	Pre-procedure WBC count	Prior to Each Spectra Optia Apheresis Procedure
Post-procedure WBC Count	Post-procedure WBC count	Following apheresis procedure
Patient's Platelet Count Pre-depletion Procedure	Patient's platelet count pre-depletion procedure	Prior to Each Spectra Optia Apheresis Procedure
Patient's Platelet Count Post-depletion Procedure	Patient's platelet count post-depletion procedure	Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
Whole Blood Processed (mL)	Volume of patient's blood processed in mL during the apheresis procedure	Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
Whole Blood Flow mL/Min	Whole Blood Flow in mL/min measured during the white blood cell depletion procedure	Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
Procedure Duration	The duration of the WBCD procedure measured in minutes	Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
Platelet Change (% Change)	% change in patient's pre and post-depletion procedure platelet counts	Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
Waste Bag Volume	Volume of the depletion product	Post each Spectra Optia Apheresis Procedure

Collaborators and Investigators

• Sponsor: Terumo BCT
• Investigators: Study Director: Isobelle Galeon, MD, MPH, MSCS, Medical Monitor, Clinical Safety

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 27, 2014

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: apheresis; white blood cell depletion
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Leukocyte Disorders; Leukocytosis
• Other Study ID Numbers: CTS-5043