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NCT Number: NCT02302365

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.

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Key information

Conditions

Leukocytosis Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Gasthuisberg, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Spectra Optia® Apheresis System

Device

White Blood Cell Depletion

Primary outcomes

  1. Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure

    Time frame: 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%

  2. Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.

    Time frame: 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)

  3. Adverse Events

    Time frame: 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.

Other outcomes

  1. Pre-procedure WBC Count

    Time frame: Prior to Each Spectra Optia Apheresis Procedure

    Pre-procedure WBC count

  2. Post-procedure WBC Count

    Time frame: Following apheresis procedure

    Post-procedure WBC count

  3. Patient's Platelet Count Pre-depletion Procedure

    Time frame: Prior to Each Spectra Optia Apheresis Procedure

    Patient's platelet count pre-depletion procedure

  4. Patient's Platelet Count Post-depletion Procedure

    Time frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.

    Patient's platelet count post-depletion procedure

  5. Whole Blood Processed (mL)

    Time frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.

    Volume of patient's blood processed in mL during the apheresis procedure

  6. Whole Blood Flow mL/Min

    Time frame: 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 in mL/min measured during the white blood cell depletion procedure

  7. Procedure Duration

    Time frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.

    The duration of the WBCD procedure measured in minutes

  8. Platelet Change (% Change)

    Time frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.

    % change in patient's pre and post-depletion procedure platelet counts

  9. Waste Bag Volume

    Time frame: Post each Spectra Optia Apheresis Procedure

    Volume of the depletion product

Sponsors and collaborators

Lead sponsor

Terumo BCT

Industry

Registry information

Official study title

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

Acronym: WBCD

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 27, 2014
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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