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Evaluation of Spectra Optia Red Blood Cell Exchange in Sickle Cell Patients (ESSENTIAL)

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ClinicalTrials.gov Identifier: NCT01736657
Recruitment Status : Completed
First Posted : November 29, 2012
Results First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Terumo BCT

Tracking Information
First Submitted Date  ICMJE November 27, 2012
First Posted Date  ICMJE November 29, 2012
Results First Submitted Date  ICMJE August 22, 2013
Results First Posted Date  ICMJE July 14, 2014
Last Update Posted Date July 14, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
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) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
Evaluate the mean FCRa and FCRp [ Time Frame: Six months ]
The primary endpoint will evaluate 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), in the Evaluable subject population.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • Procedural Success of the Spectra Optia System in the Evaluable Population [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: upon signing consent to 24 hours post-procedure ]
    Device-related serious adverse events (SAE) in the Full Analysis Set (72 patients).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
  • Procedural Success of the Spectra Optia System in the Evaluable Population [ Time Frame: Six months ]
  • Spectra Optia System's Ability to Achieve the Desired Final Hematocrit in the Evaluable Population [ Time Frame: Six months ]
  • Device-related Serious Adverse Events (SAE) in the Full Analysis Set [ Time Frame: Six months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Spectra Optia Red Blood Cell Exchange in Sickle Cell Patients
Official Title  ICMJE Evaluation of the Spectra Optia Apheresis Red Blood Cell Exchange Protocol in Patients With Sickle Cell Disease.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Device: Red blood cell exchange in sickle cell
One Red Blood Cell Exchange using Spectra Optia Apheresis System per enrolled patient
Other Name: Specta Optia Apheresis System
Study Arms  ICMJE Experimental: Red cell exchange in sickle cell
Open arm; Red cell blood exchange for patients with sickle cell disease
Intervention: Device: Red blood cell exchange in sickle cell
Publications * Quirolo K, Bertolone S, Hassell K, Howard T, King KE, Rhodes DK, Bill J. The evaluation of a new apheresis device for automated red blood cell exchange procedures in patients with sickle cell disease. Transfusion. 2015 Apr;55(4):775-81. doi: 10.1111/trf.12891. Epub 2014 Oct 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2013)
73
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2012)
60
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01736657
Other Study ID Numbers  ICMJE CTS-5001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Terumo BCT
Study Sponsor  ICMJE Terumo BCT
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Keith Quirolo, MD Children's Hospital and Research Center at Oakland
PRS Account Terumo BCT
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP