(P-TA-14) Retrospective Analysis of Performance Metrics in Automated Red Blood Cell Exchange Procedures: A Single-Center Study

Background/Case Studies: Red blood cell (RBC) exchange and depletion/exchange are critical therapeutic procedures for patients with sickle cell disease. Reduction of patient %Hemoglobin S (HbS) and accurate achievement of prescribed post-procedure hematocrit are important for ensuring treatment efficacy and patient safety. This single-center retrospective study evaluates the accuracy of an automated cell separator in achieving target post-procedure hematocrit levels and reducing %HbS during RBC exchange and depletion/exchange treatments, based on data from the first 10 months of procedure implementation at the site.

Study

Design/Methods: A retrospective analysis was conducted on combined data from RBC exchange and depletion/exchange procedures in adult patients (N=76; Amicus Separator, 2 instruments) collected over a 10-month period (June 2023 – April 2024) at the University of Alabama Birmingham (Apheresis Services). Data collected included: procedure time, patient post-procedure %Hemoglobin S (%HbS), patient hematocrit, anticoagulant (AC) to patient, AC used, whole blood processed volume, saline to patient, and fluid balance. The accuracy of the device in meeting the target hematocrit was evaluated by calculating the ratio of the laboratory measured post-procedure hematocrit (Actual) to the target values (A:T Ratio). A 95% Confidence Interval was determined using a 1-sample t-test and compared to literature reported performance criteria indicative of an acceptable hematocrit A:T ratio (0.85 – 1.15).

Results/Findings: Procedure times averaged 75 ± 21 minutes with a total whole blood processed volume of 4553 ± 1376 mL. Patient post-procedure %HbS was 15.0 ± 2.6% and met prescribed requirements. Additional summary statistics for procedural parameters are presented in Table 1. The mean (±SD) post-procedure hematocrit (HCT) values demonstrated strong agreement with predicted values based on A:T ratio calculations (HCT: 0.96 ± 0.06), and the 95% confidence interval (HCT: 0.95–0.97) was well within the defined reference range.

Conclusions: In this retrospective analysis of RBC exchange and depletion/exchange procedures, the Amicus Separator met operator defined hematocrit targets and achieved post-procedure %HbS levels consistent with therapeutic goals. The results demonstrate the system’s capability of achieving target procedural parameters in a real world setting.