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

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Red blood cell exchange in sickle cell
Sponsored by
Terumo BCT
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's of Alabama
  • Children's Hospital and Research Center at Oakland
  • University of Colorado at Denver
  • Kosair Children's Hospital
  • Johns Hopkins Medical

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Red cell exchange in sickle cell

Arm Description

Open arm; Red cell blood exchange for patients with sickle cell disease

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
Device-related Serious Adverse Events (SAE) in the Full Analysis Set
Device-related serious adverse events (SAE) in the Full Analysis Set (72 patients).

Full Information

First Posted
November 27, 2012
Last Updated
July 10, 2014
Sponsor
Terumo BCT
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1. Study Identification

Unique Protocol Identification Number
NCT01736657
Brief Title
Evaluation of Spectra Optia Red Blood Cell Exchange in Sickle Cell Patients
Acronym
ESSENTIAL
Official Title
Evaluation of the Spectra Optia Apheresis Red Blood Cell Exchange Protocol in Patients With Sickle Cell Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Terumo BCT

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Red cell exchange in sickle cell
Arm Type
Experimental
Arm Description
Open arm; Red cell blood exchange for patients with sickle cell disease
Intervention Type
Device
Intervention Name(s)
Red blood cell exchange in sickle cell
Other Intervention Name(s)
Specta Optia Apheresis System
Intervention Description
One Red Blood Cell Exchange using Spectra Optia Apheresis System per enrolled patient
Primary Outcome Measure Information:
Title
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)
Description
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
Secondary Outcome Measure Information:
Title
Procedural Success of the Spectra Optia System in the Evaluable Population
Description
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
Title
Spectra Optia System's Ability to Achieve the Desired Final Hematocrit in the Evaluable Population
Description
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
Title
Device-related Serious Adverse Events (SAE) in the Full Analysis Set
Description
Device-related serious adverse events (SAE) in the Full Analysis Set (72 patients).
Time Frame
upon signing consent to 24 hours post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Quirolo, MD
Organizational Affiliation
Children's Hospital and Research Center at Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Children's Hospital and Research Center at Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
University of Colorado at Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Johns Hopkins Medical
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25330984
Citation
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.
Results Reference
derived

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

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