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

NCT01736657 | Completed Results

• 1 other identifier: CTS-5001
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 5

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Procedural Success of the Spectra Optia System in the Evaluable Population

  Length of the procedure

• Spectra Optia System's Ability to Achieve the Desired Final Hematocrit in the Evaluable Population

  Length of the procedure

• Device-related Serious Adverse Events (SAE) in the Full Analysis Set

  upon signing consent to 24 hours post-procedure

Study Arms (1)

Red cell exchange in sickle cell

EXPERIMENTAL

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

Device: Red blood cell exchange in sickle cell

Interventions

Red blood cell exchange in sickle cell DEVICE

One Red Blood Cell Exchange using Spectra Optia Apheresis System per enrolled patient

Also known as: Specta Optia Apheresis System

Red cell exchange in sickle cell

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Terumo BCT: lead

Study Sites (5)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

Children's Hospital and Research Center at Oakland

Oakland, California, 94609, United States

Location

University of Colorado at Denver

Aurora, Colorado, 80045, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins Medical

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 25330984 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Ray Goodrich, Phd, VP Scientifc and Clinical Affairs
• Organization: Terumo BCT, Inc.

303-205-2680

Study Officials

• Keith Quirolo, MD

  Children's Hospital and Research Center at Oakland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 14, 2014
• Results First Posted: July 14, 2014

Record last verified: 2014-01

Locations

US (5)