N/A
N=73
Evaluation of Spectra Optia Red Blood Cell Exchange in Sickle Cell Patients
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT01736657 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: 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) — 0.9 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Red blood cell exchange in sickle cell (Device)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Terumo BCT
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
0.9 | — |
| SECONDARY Procedural Success of the Spectra Optia System in the Evaluable Population |
100 | — |
| SECONDARY Spectra Optia System's Ability to Achieve the Desired Final Hematocrit in the Evaluable Population |
1.03 | — |
| SECONDARY Device-related Serious Adverse Events (SAE) in the Full Analysis Set |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01736657). 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.