A prospective trial assessing the safety and efficacy of collecting up to 840 mL of plasma in conjunction with saline infusion during plasmapheresis.

BACKGROUND: The demand for plasma for manufacturing intravenous immunoglobulin and other plasma derivatives is increasing. A prospective study was conducted to determine whether up to 840 mL of plasma could be safely and effectively collected in conjunction with saline infusion during plasmapheresis. STUDY DESIGN AND METHODS: Ninety-one plasma donors were enrolled in a modified 3 × 3 crossover study to assess the equivalence of three plasma collection methods: 750 mL of plasma with no saline (control, Method 1), 840 mL of plasma with a 250-mL saline infusion during and at the end of the donation (Method 2), and 800 mL of plasma with a 500-mL saline infusion at the end of the donation (Method 3). The primary efficacy endpoint was the total protein concentration of the collected plasma. Secondary efficacy endpoints were immunoglobulin (Ig)G and Factor (F)VIII plasma concentration and donors' acceptance of the new procedures. Safety was determined from the adverse event (AE) rate. RESULTS: The total protein, IgG, and FVIII concentrations in plasma collected under Methods 2 and 3 were significantly lower than those in plasma collected under Method 1 (p < 0.0001). These variables were also significantly lower in plasma collected under Method 2 compared to Method 3. During the study, 75 AEs were recorded, 73 of which were mild to moderate. Significantly more donors (31%) preferred Method 2 compared to Method 3 (p = 0.006). CONCLUSIONS: Saline infusion during plasmapheresis led to hemodilution of plasma proteins. However, the benefits to donor safety and satisfaction are compelling reasons to implement saline infusion during plasmapheresis.

Evaluation of the automated collection and extended storage of apheresis platelets in additive solution.

BACKGROUND: Collecting apheresis platelets (PLTs) into additive solution has many potential benefits. The new Trima software (Version 6.0, CaridianBCT) allows automated addition of PLT additive solution (PAS) after collection, compared to Trima Version 5.1, which only collects PLTs into plasma. The aim of this study was to compare PLT quality during extended storage, after collection with the different Trima systems. STUDY DESIGN AND METHODS: Apheresis PLTs were collected using both Trima Accel apheresis systems. The test PLT units (n = 12) were collected using the new Trima Version 6.0 into PLT AS (PAS-IIIM), while the control units (n = 8) were collected into autologous plasma using Trima Version 5.1. All units were stored for 9 days, and in vitro cell quality variables were evaluated during this time. RESULTS: PLTs collected in PAS-IIIM maintained a stable pH between 7.2 and 7.4, whereas plasma-stored apheresis units exhibited significantly increased acidity during storage, due to lactate accumulation and bicarbonate exhaustion. Plasma-stored PLTs also demonstrated a more rapid consumption of glucose. However, there was little difference in PLT activation or cytokine secretion between PAS-IIIM and control PLTs. CONCLUSION: These data indicate that apheresis PLT concentrates collected in PAS-IIIM, using Trima Version 6.0 software, maintained acceptable PLT metabolic and cellular characteristics until Day 9 of storage.