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期刊来源：JAMA

文献发表时间：2023-10-12

原文链接：https://jamanetwork.com/journals/jama/article-abstract/2810756

关键点内容如下：

问题

在标准护理的基础上输注早期和经验性高剂量冷沉淀是否能提高需要启动严重出血方案的创伤出血患者的生存率？

调查结果

在这项多中心、国际、随机临床试验中，1604名创伤患者接受了标准护理与常规护理加3组早期冷沉淀的比较，全因28天死亡率没有差异（26.1%vs 25.3%）。各研究组的安全性结果、输血需求或血栓事件发生率没有差异。

意义

在常规护理中增加早期和经验性高剂量冷沉淀并不能改善创伤和出血患者的临床结果。

摘要内容如下：

重要性

严重出血与创伤患者的高死亡率相关。复杂的凝血功能紊乱（包括急性纤维蛋白原缺乏）会加重出血。治疗方法是用冷沉淀输血或纤维蛋白原浓缩物替代纤维蛋白原，通常在出血期间相对较晚给药。

目的

评估是否可以通过对所有需要启动严重出血方案的创伤和出血患者给予早期和经验性高剂量冷沉淀来提高生存率。

研究设计和参与者

Cryostat-2是一项干预性、随机、开放标签、平行组对照、国际、多中心研究。从2017年8月到2021年11月，在26个英国和美国主要创伤中心招募患者。符合条件的患者是需要激活医院的主要出血方案的受伤成人，有活动性出血的证据，收缩压在任何时候都低于90毫米汞柱，并接受至少1 U的血液成分输血。

数据提取和分析

患者被随机分配（以1:1的比例）接受标准护理，即局部严重出血方案（回顾指南的依从性），或冷沉淀，其中在随机分组后90分钟和受伤后3小时内，除了标准护理外，还将给予3组冷沉淀（6-G纤维蛋白原当量）。

主要结局和措施

主要转归是意向治疗人群28天时的全因死亡率。

结果

在1604名符合条件的患者中，799名患者被随机分配到冷沉淀组，805名患者被随机分配到标准护理组。73名患者（主要是由于撤回同意书）的主要结果数据缺失，1531名（95%）患者被纳入主要分析人群。参与者的中位（IQR）年龄为39（26-55）岁，1251（79%）为男性，中位（IQR）损伤严重程度评分为29（18-43），36%有穿透性损伤，33%在到达医院时收缩压低于90 mm Hg。意向治疗人群的28天全因死亡率在标准治疗组中为26.1%，在冷沉淀治疗组中为25.3%（比值比为0.96[95%CI，0.75-1.23]；P=.74）。标准治疗组与冷沉淀组的安全性结果或血栓事件发生率无差异（12.9%vs 12.7%）。

结论和相关性

在需要激活大出血方案的创伤和出血患者中，在标准治疗中加入早期和经验性大剂量冷沉淀并不能改善全因 28 天死亡率。

英文原文如下：

Key Points

Question  Does transfusion of early and empirical high-dose cryoprecipitate in addition to standard care improve survival in bleeding patients with trauma who require activation of a major hemorrhage protocol?

Findings  In this multicenter, international, randomized clinical trial of 1604 patients with trauma comparing standard care vs usual care plus 3 early pools of cryoprecipitate, there was no difference in all-cause 28-day mortality (26.1% vs 25.3%). There was no difference in safety outcomes, transfusion requirements, or incidence of thrombotic events across study groups.

Meaning  The addition of early and empirical high-dose cryoprecipitate to usual care did not improve clinical outcomes in patients with trauma and bleeding.

Abstract

Importance  Critical bleeding is associated with a high mortality rate in patients with trauma. Hemorrhage is exacerbated by a complex derangement of coagulation, including an acute fibrinogen deficiency. Management is fibrinogen replacement with cryoprecipitate transfusions or fibrinogen concentrate, usually administered relatively late during hemorrhage.

Objective  To assess whether survival could be improved by administering an early and empirical high dose of cryoprecipitate to all patients with trauma and bleeding that required activation of a major hemorrhage protocol.

Design, Setting, and Participants  CRYOSTAT-2 was an interventional, randomized, open-label, parallel-group controlled, international, multicenter study. Patients were enrolled at 26 UK and US major trauma centers from August 2017 to November 2021. Eligible patients were injured adults requiring activation of the hospital’s major hemorrhage protocol with evidence of active hemorrhage, systolic blood pressure less than 90 mm Hg at any time, and receiving at least 1 U of a blood component transfusion.

Intervention  Patients were randomly assigned (in a 1:1 ratio) to receive standard care, which was the local major hemorrhage protocol (reviewed for guideline adherence), or cryoprecipitate, in which 3 pools of cryoprecipitate (6-g fibrinogen equivalent) were to be administered in addition to standard care within 90 minutes of randomization and 3 hours of injury.

Main Outcomes and Measures  The primary outcome was all-cause mortality at 28 days in the intention-to-treat population.

Results  Among 1604 eligible patients, 799 were randomized to the cryoprecipitate group and 805 to the standard care group. Missing primary outcome data occurred in 73 patients (principally due to withdrawal of consent) and 1531 (95%) were included in the primary analysis population. The median (IQR) age of participants was 39 (26-55) years, 1251 (79%) were men, median (IQR) Injury Severity Score was 29 (18-43), 36% had penetrating injury, and 33% had systolic blood pressure less than 90 mm Hg at hospital arrival. All-cause 28-day mortality in the intention-to-treat population was 26.1% in the standard care group vs 25.3% in the cryoprecipitate group (odds ratio, 0.96 [95% CI, 0.75-1.23]; P = .74). There was no difference in safety outcomes or incidence of thrombotic events in the standard care vs cryoprecipitate group (12.9% vs 12.7%).

Conclusions and Relevance  Among patients with trauma and bleeding who required activation of a major hemorrhage protocol, the addition of early and empirical high-dose cryoprecipitate to standard care did not improve all cause 28-day mortality.

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