Nascimento B, Goodnough L T, Levy J H
Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.
Departments of Pathology and Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.
Br J Anaesth. 2014 Dec;113(6):922-34. doi: 10.1093/bja/aeu158. Epub 2014 Jun 27.
Cryoprecipitate, originally developed as a therapy for patients with antihaemophilic factor deficiency, or haemophilia A, has been in use for almost 50 yr. However, cryoprecipitate is no longer administered according to its original purpose, and is now most commonly used to replenish fibrinogen levels in patients with acquired coagulopathy, such as in clinical settings with haemorrhage including cardiac surgery, trauma, liver transplantation (LT), or obstetric haemorrhage. Cryoprecipitate is a pooled product that does not undergo pathogen inactivation, and its administration has been associated with a number of adverse events, particularly transmission of blood-borne pathogens and transfusion-related acute lung injury. As a result of these safety concerns, along with emerging availability of alternative fibrinogen preparations, cryoprecipitate has been withdrawn from use in a number of European countries. Compared with the plasma from which it is prepared, cryoprecipitate contains a high concentration of coagulation factor VIII, coagulation factor XIII, and fibrinogen. Cryoprecipitate is usually licensed by regulatory authorities for the treatment of hypofibrinogenaemia, and recommended for supplementation when plasma fibrinogen levels decrease below 1 g litre(-1); however, this threshold is empiric and is not based on solid clinical evidence. Consequently, there is uncertainty over the appropriate dosing and optimal administration of cryoprecipitate, with some guidelines from professional societies to guide clinical practice. Randomized, controlled trials are needed to determine the clinical efficacy of cryoprecipitate, compared with the efficacy of alternative preparations. These trials will allow the development of evidence-based guidelines in order to inform physicians and guide clinical practice.
冷沉淀最初是作为治疗抗血友病因子缺乏症(即甲型血友病)患者的一种疗法而研发的,至今已使用了近50年。然而,冷沉淀如今已不再按照其最初的用途给药,目前最常用于补充获得性凝血病患者的纤维蛋白原水平,比如在心脏手术、创伤、肝移植(LT)或产科出血等出血的临床情况下。冷沉淀是一种未经病原体灭活处理的混合制品,其使用与多种不良事件相关,尤其是血源性病原体的传播和输血相关的急性肺损伤。由于这些安全问题,再加上其他纤维蛋白原制剂的出现,冷沉淀在一些欧洲国家已不再使用。与制备冷沉淀所用的血浆相比,冷沉淀含有高浓度的凝血因子VIII、凝血因子 XIII 和纤维蛋白原。冷沉淀通常获监管机构批准用于治疗低纤维蛋白原血症,当血浆纤维蛋白原水平降至1 g/L以下时推荐补充使用;然而,这个阈值是经验性的,并非基于确凿的临床证据。因此,冷沉淀的合适剂量和最佳给药方式存在不确定性,专业学会有一些指南来指导临床实践。需要进行随机对照试验,以确定冷沉淀与其他制剂相比的临床疗效。这些试验将有助于制定循证指南,为医生提供参考并指导临床实践。