An interventional study of Red blood cell exchange in sickle cell in Sickle Cell Disease, sponsored by Terumo BCT. Completed at 5 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2014-07-14.
Sponsored by Terumo BCT · Not applicable, Interventional, and Treatment
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.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 73 is above the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Terumo BCT is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Open arm; Red cell blood exchange for patients with sickle cell disease
Device: Red blood cell exchange in sickle cell
One Red Blood Cell Exchange using Spectra Optia Apheresis System per enrolled patient
Also known as: Specta Optia Apheresis System
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
Recruitment period: Nov 2012 through May 2013
| Milestone | Red Blood Cell Exchange for Patients With Sickle Cell Disease |
|---|---|
| Started | 73 |
| Completed | 72 |
| Not completed | 1 |
| Withdrew: Insufficient vascular access | 1 |
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.
| ratio | Red Blood Cell Exchange for Patients With Sickle Cell Disease |
|---|---|
| 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 (0.855 to 0.941) |
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).
| percentage of participants | Red Blood Cell Exchange for Patients With Sickle Cell Disease |
|---|---|
| Procedural Success of the Spectra Optia System in the Evaluable Population | 100 |
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.
| ratio | Red Blood Cell Exchange for Patients With Sickle Cell Disease |
|---|---|
| Spectra Optia System's Ability to Achieve the Desired Final Hematocrit in the Evaluable Population | 1.03 (1.011 to 1.045) |
Device-related serious adverse events (SAE) in the Full Analysis Set (72 patients).
| participants | Red Blood Cell Exchange for Patients With Sickle Cell Disease |
|---|---|
| Device-related Serious Adverse Events (SAE) in the Full Analysis Set | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Red Blood Cell Exchange for Patients With Sickle Cell Disease | — | 0/72 (0%) | 10/72 (13.9%) |
| Event | Red Blood Cell Exchange for Patients With Sickle Cell Disease |
|---|---|
| DizzinessNervous system disorders | 6/72 |
| NauseaGastrointestinal disorders | 4/72 |
Seventy-two patients were in safety analysis and 60 patients (evaluable popluation) were analyzed in the efficacy analysis. The 12 patients not in the efficacy analysis were "lead-in" patients and the RBCX procedures were conducted as the last phase in Operator training on the device.
| Age, Categorical(Participants) | Red Blood Cell Exchange for Patients With Sickle Cell Disease |
|---|---|
| <=18 years | 26 |
| Between 18 and 65 years | 46 |
| >=65 years | 0 |
| Age, Continuous(years) | Red Blood Cell Exchange for Patients With Sickle Cell Disease |
|---|---|
| Mean | 23.0 ± 10.32 |
| Sex: Female, Male(Participants) | Red Blood Cell Exchange for Patients With Sickle Cell Disease |
|---|---|
| Female | 29 |
| Male | 43 |
| Region of Enrollment(participants) | Red Blood Cell Exchange for Patients With Sickle Cell Disease |
|---|---|
| United States | 72 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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