The purpose of this study is to evaluate the performance of the Spectra Optia system red blood cell exchange (RBCx) protocols (exchange and depletion/exchange) in study participants with sickle cell disease.
Evaluate the performance of the Spectra Optia system red blood cell exchange (RBCx) protocols (exchange and depletion/exchange) in study participants with sickle cell disease. Open label design.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
One Red Blood Cell Exchange using Spectra Optia Apheresis System per enrolled patient
Children's of Alabama
Birmingham, Alabama, United States
Children's Hospital and Research Center at Oakland
Oakland, California, United States
University of Colorado at Denver
Aurora, Colorado, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Mean Ratio Actual Fraction of Cells Remaining (FCRa; as Measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp; as Predicted by the Spectra Optia System FCR Algorithm Multiplied by the Pre-Procedure % HbS)
The primary endpoint evaluated the mean ratio of the Actual Fraction of Cells Remaining (FCRa: as measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp: as predicted by the Spectra Optia system FCR algorithm multiplied by the Pre-Procedure % HbS), in the evaluable population (60 pts). The pre-defined range for the mean ratio of the FCRa to the FCRp was 0.75 to 1.25.
Time frame: Length of the procedure
Procedural Success of the Spectra Optia System in the Evaluable Population
The procedural success of the Spectra Optia System is defined as the ability of the device to complete a red blood cell exchange (RBCx) and to obtain a satisfactory exchange by lowering the patient's hemoglobin S, as determined by the investigator in the evaluable population (60 pts).
Time frame: Length of the procedure
Spectra Optia System's Ability to Achieve the Desired Final Hematocrit in the Evaluable Population
Measurement of the patient post-procedure hematocrit compared to the final target hematocrit calculated by the Spectra Optia Apheresis System. Final target hematocrit was calculated by tracking the number of red cells coming into the system versus the number of red cells removed.
Time frame: Length of the procedure
Device-related Serious Adverse Events (SAE) in the Full Analysis Set
Device-related serious adverse events (SAE) in the Full Analysis Set (72 patients).
Time frame: upon signing consent to 24 hours post-procedure
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Johns Hopkins Medical
Baltimore, Maryland, United States