Evaluation of an automated system for the collection of packed RBCs, platelets, and plasma

BACKGROUND: This study evaluated the quality of WBC-reduced platelets, RBCs , and plasma collected on a new system (Trima, Gambro BCT) designed to auto mate the collection of all blood components. The study also evaluated donor safety and suitability of these components for transfusion. STUDY DESIGN AND METHODS: In Phase I, the quality of the components collect ed on the new system was evaluated by standard in vitro and in vivo testing methods. Results were compared to those from control components collected by currently approved standard methods. In Phase II, additional collections were performed to evaluate the acceptability of the new system and the saf ety of platelets collected. RESULTS: In vivo 24-hour RBC recovery was 76.8 +/- 3.1 percent for the test RBC units and 77.1 +/- 4.4 percent recovery for whole-blood (control) RBCs . The differences between test and control platelet results in the in vivo and in vitro assays were not clinically significant. Plasma clotting factor s and fibrinogen levels met international standards. The system was well ac cepted by donors, and no major adverse donor reactions were reported for th e 68 procedures performed. No problems were reported with transfusing the b lood components collected. CONCLUSION: Blood components collected with the Trima are equivalent to cur rently available components, and they meet the applicable regulatory standa rds. This system provides consistent, standardized components with predicta ble yields. It provides the option of fully automating the collection of al l blood components.