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

Terumo

Status

Completed

Conditions

Sickle Cell Disease

Treatments

Device: Red blood cell exchange in sickle cell

Study type

Interventional

Funder types

Industry

Identifiers

NCT01736657

CTS-5001

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

12+ years old

Volunteers

No 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.