N/A
N=43
Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion
Leukocytosis
Bottom Line
View on ClinicalTrials.gov: NCT02302365 ↗Enrolled (actual)
43
Serious AEs
1.3%
Results posted
Mar 2016
Primary outcome: Primary: Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure — 54.5 % change in subject's WBC count
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Spectra Optia® Apheresis System (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Terumo BCT
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure |
54.5 | — |
| PRIMARY Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia. |
58.7 | — |
| PRIMARY Adverse Events |
37; 30 | — |
Summary
This study is a multicenter, retrospective data collection of routine clinical use with the Spectra Optia® apheresis system for white blood cell depletion.
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
Data sourced from ClinicalTrials.gov (NCT02302365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.