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

Leukocytosis Clinical Trial

— WBCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302365
• Other study ID #: CTS-5043
• Status: Completed
• Start date: April 2014
• Est. completion date: July 2017

Study information

• Verified date: July 2018
• Source: Terumo BCT
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Leukocytosis

Intervention

Device:
• Spectra Optia® Apheresis System
White Blood Cell Depletion

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg	Leuven
Germany	Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden-Württemberg-Hessen gGmbH, Johann-Wolfgang-Goethe-University Hospital	Frankfurt/Main
Hungary	Szent Istvan and Szent Laszlo Hospital of Budapest	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Terumo BCT

Countries where clinical trial is conducted

Belgium,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pre-procedure WBC Count	Pre-procedure WBC count	Prior to Each Spectra Optia Apheresis Procedure
Other	Post-procedure WBC Count	Post-procedure WBC count	Following apheresis procedure
Other	Patient's Platelet Count Pre-depletion Procedure	Patient's platelet count pre-depletion procedure	Prior to Each Spectra Optia Apheresis Procedure
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	Waste Bag Volume	Volume of the depletion product	Post each Spectra Optia Apheresis Procedure
Primary	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
Primary	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
Primary	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.