OA1-AM24-SN-23 - Clinical Evaluation of Leukoreduced Red Blood Cells After Automated Separation of Whole Blood by the Reveos™ System and Storage for 42 Days

Ensuring standardized and consistent blood components is imperative for meeting the medical demands for life-saving blood transfusions. The Reveos™ Automated Blood Processing System (Reveos System) reduces logistical issues with manual blood processing and provides consistent blood component yield and quality. The objective of this study was to evaluate whether leukoreduced red blood cells (LR-RBCs) derived from whole blood (WB) and processed with the Reveos System met the United States Food and Drug Administration (FDA) criteria for in vivo 24-hour RBC recovery after 42-day storage.

Study

Design/Methods:

This was a prospective, open-label in vivo study (n=26) conducted at two sites. A unit of citrate phosphate dextrose (CPD) WB (500mL ±10%) was collected from healthy volunteers, processed, and separated into components (red blood cells [RBCs], plasma, and platelets). The RBCs were diluted with Additive Solution Formula 5 (AS-5) and leukoreduced with a filter integrated into the Reveos SELECT Set. They were then measured for mass recovery and leukoreduction and stored at 1-6°C for 42 days.

On Day 42, stored LR-RBC units were radiolabeled with chromium-51 (⁵¹Cr). An aliquot of freshly collected and prepared RBCs was also radiolabeled with technetium-99m (^99mTc). The labeled aliquots were then combined and autologously infused into the participant. Blood samples were collected from the participants at approximately 5-, 7.5-, 10-, 12.5-, 15-, 20-, and 30-minutes post-infusion and 24 (± 2) hours post-infusion. The primary endpoint was the 24-hour in vivo % RBC recovery based on the FDA criteria of a 24-hour recovery ≥ 75% with standard deviation (SD) ≤ 9% and a one-sided lower confidence limit for the population proportion of RBCs in vivo recovery of 70% with a “success” being LR-RBC recovery >75%.

Results/Findings: This study enrolled 37 participants to achieve 26 evaluable recovery endpoints. For the single label method (⁵¹Cr), there were 23 successes and three failures with a mean 24-hour RBC recovery of 83% (SD = 9%) and a one-sided 95% lower confidence limit for the proportion of successes of 73%. For the dual label method (⁵¹Cr /^99mTc), there were 24 successes and two failures, with a mean 24-hour RBC recovery value of 90% (SD = 9%) and a one-sided 95% lower confidence limit of 78%. Both single-label and dual-label met the FDA criteria. In all units, red cell mass was > 85% at Day 0, residual white blood cell content was < 5x10⁶ at Day 0, and hemolysis levels were < 1% at Day 42.

Conclusions: The Reveos System worked as expected, performed safely, and met the FDA’s criteria for 24-hour in vivo RBC recovery after 42-day storage. This technology will assist in providing standardized RBC products for transfusion while optimizing blood center efficiency.