Evaluation of Spectra Optia Red Blood Cell Exchange in Sickle Cell Patients

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

At least 12 years old
Enrolled in a program of regular red blood cell exchange (RBCx) to prevent symptoms/complications of sickle cell disease (SCD) or Initiating a program of regular RBCx or Receiving RBCx as a pre-surgical procedure.
Medically stable
Previous documentation of diagnosis by hemoglobin electrophoresis of a type of sickle cell disorder requiring RBCx.
Sufficient vascular access to accommodate the RBCx procedure as determined by the apheresis technician performing the procedure or phlebotomist responsible for obtaining intravenous access.
Availability of sickle trait negative, leukoreduced, ABO blood group, Rhesus factor D (Rh (D)) compatible, unexpired replacement blood. See Glossary for definition of replacement blood.
Able to commit to the study follow-up schedule.
Agree to report adverse events (AEs) during the required reporting period.

Exclusion Criteria

Inability to obtain informed consent/assent from patient, or permission from parent or guardian.
Pregnancy (negative serum pregnancy test required for females of childbearing potential).
Life expectancy is fewer than 30 days from time of procedure.
Incarcerated or a ward of the court.
Refusal of blood products.
Failure to comply with site standard requirements for cessation of medications (e.g., angiotensin converting enzyme (ACE) inhibitors) that interfere with or increase risk of RBCx procedures.
History of drug or alcohol abuse that, in the opinion of the investigator, could affect the ability of the patient to comply with the study requirements Inability to comply with the protocol in the opinion of the investigator.

Arm && Interventions

Group	Intervention	Description
Red cell exchange in sickle cell	Red blood cell exchange in sickle cell	Open arm; Red cell blood exchange for patients with sickle cell disease

Primary Outcome Measures

Name	Time	Method
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)	Length of the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Procedural Success of the Spectra Optia System in the Evaluable Population	Length of the procedure	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).
Spectra Optia System's Ability to Achieve the Desired Final Hematocrit in the Evaluable Population	Length of the procedure	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.
Device-related Serious Adverse Events (SAE) in the Full Analysis Set	upon signing consent to 24 hours post-procedure	Device-related serious adverse events (SAE) in the Full Analysis Set (72 patients).

Locations (5): Children's of Alabama
🇺🇸
Birmingham, Alabama, United States
Children's Hospital and Research Center at Oakland
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Oakland, California, United States
Kosair Children's Hospital
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Louisville, Kentucky, United States
University of Colorado at Denver
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Aurora, Colorado, United States
Johns Hopkins Medical
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Baltimore, Maryland, United States