Research and Development, Australian Red Cross Blood Service, Alexandria, New South Wales, Australia.
Transfusion. 2012 Aug;52(8):1806-13. doi: 10.1111/j.1537-2995.2012.03561.x. Epub 2012 Feb 20.
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.
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.
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).
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.
对用于制造静脉注射免疫球蛋白和其他血浆衍生物的血浆的需求正在增加。进行了一项前瞻性研究，以确定在血浆分离期间联合盐水输注是否可以安全有效地采集多达 840 毫升的血浆。
91 名血浆供体参加了一项改良的 3×3 交叉研究，以评估三种血浆采集方法的等效性：无盐水的 750 毫升血浆（对照，方法 1）、捐赠过程中和结束时输注 250 毫升盐水的 840 毫升血浆（方法 2），以及捐赠结束时输注 500 毫升盐水的 800 毫升血浆（方法 3）。主要疗效终点是采集的血浆的总蛋白浓度。次要疗效终点是免疫球蛋白（IgG）和因子（F）VIII 血浆浓度以及供体对新程序的接受程度。从不良事件（AE）发生率确定安全性。
方法 2 和 3 下采集的血浆中的总蛋白、IgG 和 FVIII 浓度明显低于方法 1 下采集的血浆（p<0.0001）。与方法 3 相比，方法 2 下采集的这些变量也明显更低。在研究期间，记录了 75 例不良事件，其中 73 例为轻度至中度。与方法 3 相比，明显更多的供体（31%）更喜欢方法 2（p=0.006）。
血浆分离期间的盐水输注导致血浆蛋白的血液稀释。然而，对供体安全性和满意度的好处是实施血浆分离期间盐水输注的有力理由。
