NHS Blood and Transplant, Oxford Radcliffe Hospitals NHS Trust and University of Oxford, Headley Way, Oxford, OX3 9BQ, UK.
Crit Care. 2011;15(2):R92. doi: 10.1186/cc10096. Epub 2011 Mar 9.
Worldwide, trauma is a leading cause of death and disability. Haemorrhage is responsible for up to 40% of trauma deaths. Recent strategies to improve mortality rates have focused on optimal methods of early hemorrhage control and correction of coagulopathy. We undertook a systematic review of randomized controlled trials (RCT) which evaluated trauma patients with hemorrhagic shock within the first 24 hours of injury and appraised how the interventions affected three outcomes: bleeding and/or transfusion requirements; correction of trauma induced coagulopathy and mortality.
Comprehensive searches were performed of MEDLINE, EMBASE, CENTRAL (The Cochrane Library Issue 7, 2010), Current Controlled Trials, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP) and the National Health Service Blood and Transplant Systematic Review Initiative (NHSBT SRI) RCT Handsearch Database.
A total of 35 RCTs were identified which evaluated a wide range of clinical interventions in trauma hemorrhage. Many of the included studies were of low methodological quality and participant numbers were small. Bleeding outcomes were reported in 32 studies; 7 reported significantly reduced transfusion use following a variety of clinical interventions, but this was not accompanied by improved survival. Minimal information was found on traumatic coagulopathy across the identified RCTs. Overall survival was improved in only three RCTs: two small studies and a large study evaluating the use of tranexamic acid.
Despite 35 RCTs there has been little improvement in outcomes over the last few decades. No clear correlation has been demonstrated between transfusion requirements and mortality. The global trauma community should consider a coordinated and strategic approach to conduct well designed studies with pragmatic endpoints.
在全球范围内,创伤是导致死亡和残疾的主要原因。出血导致多达 40%的创伤死亡。最近提高死亡率的策略主要集中在早期出血控制和纠正凝血功能障碍的最佳方法上。我们对评价创伤失血性休克患者的随机对照试验(RCT)进行了系统评价,这些患者在受伤后 24 小时内接受评估,并评估了干预措施对以下三个结果的影响:出血和/或输血需求;纠正创伤引起的凝血功能障碍和死亡率。
对 MEDLINE、EMBASE、CENTRAL(Cochrane 图书馆 2010 年第 7 期)、当前对照试验、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台(ICTRP)和英国国家卫生服务局血液与移植系统评价倡议(NHSBT SRI)RCT 手工检索数据库进行了全面检索。
共确定了 35 项 RCT,评估了创伤性出血中广泛的临床干预措施。许多纳入的研究方法学质量较低,参与者人数较少。32 项研究报告了出血结果;7 项研究报告了多种临床干预措施后输血使用显著减少,但这并没有带来生存率的提高。在确定的 RCT 中,关于创伤性凝血功能障碍的信息很少。只有三项 RCT 总体生存率得到改善:两项小型研究和一项大型研究评估了氨甲环酸的使用。
尽管进行了 35 项 RCT,但在过去几十年中,结果几乎没有改善。输血需求和死亡率之间没有明显的相关性。全球创伤界应考虑采取协调一致的策略,开展设计合理、具有实用终点的研究。