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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Terumo BCT
ClinicalTrials.gov Identifier:
NCT01736657
First received: November 27, 2012
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Sickle Cell Disease
Device: Red blood cell exchange for patients with sickle cell disease

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Spectra Optia Apheresis Red Blood Cell Exchange Protocol in Patients With Sickle Cell Disease.

Resource links provided by NLM:


Further study details as provided by Terumo BCT:

Primary Outcome Measures:
  • Evaluate the mean ratio of FCRa to FCRp [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Procedural Success of the Spectra Optia system in the Evaluable population [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Spectra Optia system's ability to achieve the desired final hematocrit in the Evaluable population [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Device-related serious adverse events (SAE) in the Full Analysis Set [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Enrollment: 73
Study Start Date: November 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Red blood cell exchange for patients with sickle cell disease Device: Red blood cell exchange for patients with sickle cell disease
The purpose of this study is to evaluate the performance of the Spectra Optia system.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 12 years old
  • Enrolled in a program of regular 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, 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., 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736657

Locations
United States, Alabama
Children's of Alabama
Birmingham, Alabama, United States, 35233
United States, California
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609
United States, Colorado
University of Colorado at Denver
Aurora, Colorado, United States, 80045
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins Medical
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Terumo BCT
Investigators
Principal Investigator: Keith Quirolo, MD Children's Hospital and Research Center at Oakland
  More Information

No publications provided

Responsible Party: Terumo BCT
ClinicalTrials.gov Identifier: NCT01736657     History of Changes
Other Study ID Numbers: CTS-5001
Study First Received: November 27, 2012
Last Updated: July 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 15, 2014