Clinical trial NCT01736657: Evaluation of Spectra Optia Red Blood Cell Exchange in Sickle Cell Patients
Official title: Evaluation of the Spectra Optia Apheresis Red Blood Cell Exchange Protocol in Patients With Sickle Cell Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: Terumo BCT
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 73
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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)
timeFrame: Length of the procedure
Secondary outcomes:
measure: Procedural Success of the Spectra Optia System in the Evaluable Population
timeFrame: Length of the procedure
measure: Spectra Optia System's Ability to Achieve the Desired Final Hematocrit in the Evaluable Population
timeFrame: Length of the procedure
measure: Device-related Serious Adverse Events (SAE) in the Full Analysis Set
timeFrame: upon signing consent to 24 hours post-procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
city: Oakland
country: United States
facility: Children's Hospital and Research Center at Oakland
state: California
city: Aurora
country: United States
facility: University of Colorado at Denver
state: Colorado
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Medical
state: Maryland
Study officials:
affiliation: Children's Hospital and Research Center at Oakland
name: Keith Quirolo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.