2012年1月17日美国食品和药品监督管理局(FDA)P批准Octaplas，一种合并血浆(人)血液制品在某些患者水平不够充分的医学情况为替代凝血蛋白(凝血因子)。凝固蛋白缺乏可能引起过量出血或过量凝固。
Octaplas是一种无菌，来自几位供体的合并人血浆的冷冻溶液，曾经溶剂去垢剂过程处理。这个过程杀死某些病毒因而缩小严重病毒传播的风险。用于制造Octaplas的血浆从美国供体采集，曾被筛选和检验通过血液传播的疾病，和被确定是适宜的供体。
美国FDA生物制品评价和研究中心主任Karen Midthun，M.D. 说：“对于有凝血障碍患者，这个产品提供一种单个供体新鲜冰冻血浆有生活力替代品和提供减低某些病毒传播的风险。”
像新鲜冰冻血浆一样，Octaplas应与接受者的血型匹配避免输血反应。Octaplas增加的优点是每批产品都检验关键性凝血因子的组成和只有水平在接受范围内才发放。
Octaplas曾在欧洲和其他国家被广泛使用。既往Octaplas代产品在1992年首次上市，而当前版本自从2006上市。所有各代产品有相似的制造过程和可比的有效成分即性质。在美国以外，总共曾治疗超过2 百万患者用超过7百万剂量的 Octaplas。
Octaplas的许可主要根据在有肝脏疾病，肝脏移植，心脏手术和TTP患者中的临床研究。支持Octaplas在美国市场安全使用的另外数据来自欧洲和其他被批准上市既往使用产品。产品在欧洲使用不伴随输血相关急性肺损伤，一种使用血浆单个单元输注时不常见但严重风险。
在临床研究中观察到最常见不良反应包括气短，眩晕，胸部不适，皮肤瘙痒和皮疹，头痛和刺痛感觉。
产品由奥地利维也纳Octapharma公司制造。
Clotting factor activity in thawed Octaplas® LG during storage at 2–6°C for 6days from a quality assurance point of view
Introduction
Octaplas® LG is a second-generation solvent/detergent-treated plasma that offers an additional safety benefit by prion elimination. The stability of clotting factors of the new S/D plasma after thawing has not been investigated yet. This study intended to measure the time course of fibrinogen, FII, FV, FVII, FVIII, FIX, PC, fPS and PI through storage at 2–6°C over 6days.
Materials and methods
We investigated 20 plasma bags (five bags per blood group) and measured fibrinogen, FII, FV, FVII, FVIII, FIX, PC, fPS and PI immediately after thawing and after 2, 4, 6, 24, 48, 72, 96, 120 and 144h storage at 2–6°C. Five separate plasma bags were thawed and stored at 2–6°C for microbiological assessment. After 6days samples were drawn for blood cultures that were incubated for six more days.
Results
After 6days FII, FIX and PC showed no significant changes. FV (−16%, p<0.001), FVII (−19%, p<0.001), FVIII (−19%, p<0.001), FXI (−13%, p<0.0001) and fPS (−4%, p<0.0007) decreased significantly. PI levels were stable at 56%. The microbiological investigation showed no bacterial contamination.
Conclusions
In Octaplas® LG plasma clotting factors decreased slightly through storage of 6days. PI levels were remarkably higher and stable over time in the new Octaplas® LG. Stability of stored Octaplas® LG was limited by the decrease of FVIII to 53%, which may warrant storage up to 24h from a quality assurance point of view. This could result in reduced plasma wastage and costs for healthcare givers.