Clinical trial NCT02302365: Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion
Official title: Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukocytosis
Keywords: white blood cell depletion
apheresis
Lead sponsor: Terumo BCT
Sponsor class: INDUSTRY
First posted: 2014-11-27
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure
timeFrame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure
measure: Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.
timeFrame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure
measure: Adverse Events
timeFrame: Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.
Secondary outcomes:
Other outcomes:
measure: Pre-procedure WBC Count
timeFrame: Prior to Each Spectra Optia Apheresis Procedure
measure: Post-procedure WBC Count
timeFrame: Following apheresis procedure
measure: Patient's Platelet Count Pre-depletion Procedure
timeFrame: Prior to Each Spectra Optia Apheresis Procedure
measure: Patient's Platelet Count Post-depletion Procedure
timeFrame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
measure: Whole Blood Processed (mL)
timeFrame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
measure: Whole Blood Flow mL/Min
timeFrame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
measure: Procedure Duration
timeFrame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
measure: Platelet Change (% Change)
timeFrame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
measure: Waste Bag Volume
timeFrame: Post each Spectra Optia Apheresis Procedure
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Frankfurt/Main
country: Germany
facility: Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden-Württemberg-Hessen gGmbH, Johann-Wolfgang-Goethe-University Hospital
city: Budapest
country: Hungary
facility: Szent Istvan and Szent Laszlo Hospital of Budapest
Study officials:
affiliation: Medical Monitor, Clinical Safety
name: Isobelle Galeon, MD, MPH, MSCS
role: STUDY_DIRECTOR
References: