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

Sickle Cell Disease Clinical Trial

— ESSENTIAL  

Official title:

Evaluation of the Spectra Optia Apheresis Red Blood Cell Exchange Protocol in Patients With Sickle Cell Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736657
• Other study ID #: CTS-5001
• Status: Completed
• Phase: N/A
• First received: November 27, 2012
• Last updated: July 10, 2014
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Terumo BCT
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Device:
• Red blood cell exchange in sickle cell
One Red Blood Cell Exchange using Spectra Optia Apheresis System per enrolled patient

Locations

Country	Name	City	State
United States	University of Colorado at Denver	Aurora	Colorado
United States	Johns Hopkins Medical	Baltimore	Maryland
United States	Children's of Alabama	Birmingham	Alabama
United States	Kosair Children's Hospital	Louisville	Kentucky
United States	Children's Hospital and Research Center at Oakland	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Terumo BCT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	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.	Length of the procedure	No
Secondary	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).	Length of the procedure	No
Secondary	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.	Length of the procedure	No
Secondary	Device-related Serious Adverse Events (SAE) in the Full Analysis Set	Device-related serious adverse events (SAE) in the Full Analysis Set (72 patients).	upon signing consent to 24 hours post-procedure	No