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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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.


Sponsor: Terumo BCT

Current Primary Outcome:

  • Percent Change in White Blood Cell Count in Patient Following Apheresis Procedure [ Time Frame: immediately after procedure: on average this will be within 15minutes after the end of the procedure ]
    (WBCpre - WBCpost) / WBCpre x 100%
  • Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia. [ Time Frame: immediately: on average this will be within 15minutes after the end of the procedure ]
    (WBC/µL product x product volume) / ((WBCpre + WBCpost) / 2) x total processed blood volume)
  • Adverse Events [ 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. ]


Original Primary Outcome:

  • Percent decrease in white blood cell count in patient following apheresis procedure [ Time Frame: immediately after procedure: on average this will be within 15minutes after the end of the procedure ]
    (WBCpre - WBCpost) / WBCpre x 100%
  • Collection efficiency for WBC achieved by Spectra Optia. ((WBC/µL product x product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume) [ Time Frame: immediately: on average this will be within 15minutes after the end of the procedure ]
    (WBC/µL product x product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume
  • Adverse Events [ Time Frame: during the white blood cell apheresis procedure and for 2 hours post-procedure ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Terumo BCT

Dates:
Date Received: November 18, 2014
Date Started: April 2014
Date Completion:
Last Updated: February 3, 2016
Last Verified: November 2015