The purpose of this study is to evaluate the performance of the AMICUS Red Blood Cell Exchange (RBCx) System (Exchange and Depletion/Exchange procedures) in patients with sickle cell disease.
The goal of Red Blood Cell Exchange is to remove a patient's red blood cells (RBCs) and replace the blood volume removed with either healthy donor RBCs and/or colloid/crystalloid solutions. Depending on the RF used, the procedure can be considered an RBC Exchange or RBC Depletion/Exchange procedure. The RBC Depletion/Exchange procedure is a modification of the RBC Exchange procedure. The AMICUS RBCx protocol provides the ability to use various RFs including healthy donor RBCs or a combination of fluids, such as saline followed by RBCs. In RBC Exchange and the exchange portion of the RBC Depletion/Exchange procedures, RBC units are used as the RF, while colloid and/or crystalloid solutions are used as the RF in the depletion portion of the RBC Depletion/Exchange procedures. A new operating protocol on the AMICUS Separator that enables the device to perform Red Blood Cell Exchange (RBCx) procedures in accordance with the replacement fluid(s) (RF) prescribed by a physician for patients with sickle cell disease
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
83
Each patient will be treated with one RBCx procedure using the AMICUS RBCx System
Phoenix Children's Hospital
Phoenix, Arizona, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Actual Fraction of Original Red Blood Cells Remaining to the Target Fraction of Cells Remaining (FCR).
The primary endpoint will evaluate the mean ratio of the Actual FCR (FCRa) to Target FCR (FCRt) as measured by the patient's Hb S pre-procedure and post-procedure. The predefined mean ratio of the FCRa to FCRt is 0.75 to 1.25.
Time frame: Actual FCR will be assessed by taking a pre-procedure sample from the patient on the day of the procedure and a post-procedure sample approximately 10-15 min after procedure completion.
Accuracy of Patient's End Hematocrit as Measured by the Patient's Post-procedure Hematocrit.
Evaluate the accuracy of subject hematocrit post-procedure (End Hematocrit) (as measured by the patient's hematocrit at the end of the procedure) compared to the target End Hematocrit.
Time frame: Actual End Hematocrit will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
Subject Cell Loss Post-Procedure (WBC)
WBC loss post-procedure as measured with a complete blood count
Time frame: Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
Serious Adverse Events
Evaluate the number of device related serious adverse events during the procedure and approximately 18-24 hours post-procedure.
Time frame: During the procedure up to 24 hours post-procedure.
Subject Cell Loss Post-Procedure (Platelets)
Platelet loss post-procedure as measured with a complete blood count
Time frame: Patient's blood cells will be measured by taking a sample from the patient approximately 10-15 min after procedure completion.
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
BloodCenter of Wisconsin
Milwaukee, Wisconsin, United States