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

Completed · Not applicable

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT01736657

Run by

Terumo BCT

People needed

73

Starts

2012-11-01

Expected to finish

2013-06-01

Last updated by the study team

2014-07-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• University of Colorado at Denver — Aurora, Colorado, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• Johns Hopkins Medical — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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