The purpose of this study is to compare the procedures for the collection PMN cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems.
The purpose of this study is to compare the procedures for the collection of granulocyte/ polymorphonuclear (PMN) cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems and to establish the non-inferiority of the Spectra Optia Apheresis System with respect to the primary study endpoint, granulocyte/PMN cell collection efficiency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
42
In Arm 1 the first PMN cell collection will be performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System.
In Arm 2 the first PMN cell collection will be performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System.
Bonfils Blood Center
Denver, Colorado, United States
Hoxworth Blood Center
Cincinnati, Ohio, United States
Blood Centers of Wisconsin
Milwaukee, Wisconsin, United States
Granulocyte/PMN Cell Collection Efficiency
The primary endpoint is the granulocyte/PMN cell collection efficiency (CE) associated with the Granulocyte (PMN) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the PMN collection procedure.
Time frame: within 1 hour prior and within 5 minutes after each collection procedure
Performance
Comparison of collection efficiencies associated with the Granulocyte Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for white blood cells and platelets. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure.
Time frame: within 1 hour prior and within 5 minutes after each collection procedure
Characterization of Blood Product - PMN Cell Yield
Characterization of the collected blood product, specifically total PMN cell yield. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product.
Time frame: within 5 minutes after each collection procedure
Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed
Characterization of the collected blood product, specifically PMN cell yield per liter blood processed. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product and blood processed measured by the device.
Time frame: within 5 minutes after each collection procedure
Characterization of the Blood Product - PMN Cell Viability
Characterization of the collected blood product, specifically PMN cell viability measured by an assay preformed on the collected blood product.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: within 5 minutes after collection procedure
Characterization of the Blood Product - RBC Contamination
Characterization of the collected blood product, specifically red blood cell (RBC) contamination as measured by hematocrit in the collected PMN product.
Time frame: within 5 minutes after collection procedure
Characterization of the Blood Product - Volume
Characterization of the collected blood product, specifically product volume.
Time frame: within 5 minutes after collection procedure
Usability/Assessment of System Operation - Time
Procedure time for collections on the Spectra Optia vs. the COBE Spectra.
Time frame: Result captured immediately upon completion of procedure
Usability/Assessment of System Operation - Adjustments
Number of operator adjustments aimed at establishing and maintaining the plasma/ cellular interface: namely, on Spectra Optia, the adjustment of collection preference and, on COBE Spectra, the adjustment of the plasma pump flow rate.
Time frame: Adjustments known immediately upon completion of the procedure
Usability/Assessment of System Operation - Device Malfunctions
Time frame: Result know immediately upon successful completion of procedure
Safety
* Serious adverse events (SAEs) and unanticipated (serious) adverse device/procedure- related events (UADEs), adverse events (AEs). * any clinically significant changes to Complete Blood Count with differential white cell count (CBCD) and any significant changes to vital signs (temperature, heart rate, blood pressure) were captured as AEs. Also provided in full report to FDA.
Time frame: 48-hours after last procedure