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创伤大出血的输血策略

Blood transfusion strategies for major bleeding in trauma.

作者信息

Brunskill Susan J, Disegna Arthur, Wong Henna, Fabes Jeremy, Desborough Michael Jr, Dorée Carolyn, Davenport Ross, Curry Nicola, Stanworth Simon J

机构信息

Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK.

Nuffield Department of Clinical Laboratory Sciences, University of Oxford, Oxford, UK.

出版信息

Cochrane Database Syst Rev. 2025 Apr 24;4(4):CD012635. doi: 10.1002/14651858.CD012635.pub2.

Abstract

BACKGROUND

Trauma is a leading cause of morbidity and mortality worldwide. Research shows that haemorrhage and trauma-induced coagulopathy are reversible components of traumatic injury, if identified and treated early. Lack of consensus on definitions and transfusion strategies hinders the translation of this evidence into clinical practice.

OBJECTIVES

To assess the beneficial and harmful effects of transfusion strategies started within 24 hours of traumatic injury in adults (aged 16 years and over) with major bleeding.

SEARCH METHODS

CENTRAL, MEDLINE, Embase, five other databases, and three trial registers were searched on 20 November 2023. We also checked reference lists of included studies to identify any additional studies.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) of adults (aged 16 years and over) receiving blood products for the management of bleeding within 24 hours of traumatic injury.

DATA COLLECTION AND ANALYSIS

We used standard Cochrane methodology to perform the review and assessed the certainty of the evidence using GRADE.

MAIN RESULTS

We included 18 RCTs with 5041 participants. Comparison 1: Prehospital transfusion strategies Five studies compared use of plasma (fresh frozen plasma (FFP) or lyophilised plasma) versus 'standard of care'. We are uncertain of the effect of plasma on all-cause mortality at 24 hours (risk ratio (RR) 1.05, 95% confidence interval (CI), 0.48 to 2.30; 3 studies, 279 participants; very low certainty evidence). There is probably no difference between plasma and standard of care in all-cause mortality at 30 days (RR 0.95, 95% CI 0.78 to 1.17; 3 studies, 664 participants; moderate-certainty evidence). However, the results of one cluster-RCT that could not be included in our meta-analysis suggested that plasma may be associated with a lower risk of death at 30 days (RR 0.54, 95% CI 0.42 to 0.70; 1 study, 481 participants; low-certainty evidence). There may be no difference between plasma and standard of care in the total number of thromboembolic events in 30 days (RR 1.23, 95% CI 0.67 to.2.27; 4 studies, 586 participants; low-certainty evidence). Comparison 2: In-hospital transfusion strategies Ten studies evaluated this comparison, seven providing usable data. The studies evaluated cryoprecitate (three studies); fixed-ratio blood component transfusion (three studies); fresh frozen plasma (FFP) (one study); lyophilised plasma (one study); leucoreduced red blood cells (one study); and a restrictive transfusion strategy (one study). All-cause mortality at 24 hours For all-cause mortality at 24 hours, there is probably no difference between: • cryoprecipitate plus a major haemorrhage protocol (MHP) versus MHP alone (RR 0.92, 95% CI 0.70 to 1.21; 1 study, 1577 participants; moderate-certainty evidence); and • blood products (plasma:platelets:red blood cells (RBCs)) transfused in 1:1:1 ratio versus 1:1:2 ratio (RR 0.75, 95% CI 0.52 to 1.08; 1 study, 680 participants; moderate-certainty evidence). We are uncertain of the effect on all-cause mortality at 24 hours for: • blood products (RBCs:FFP) transfused in 1:1 ratio versus transfusion according to coagulation and full blood count results (Peto odds ratio (POR) 0.45, 0.17 to 1.22; 1 study, 434 participants; very low certainty evidence); and • lyophilised (FlyP) plasma versus FFP (POR 1.04, 95% CI 0.06 to 17.23; 1 study, 47 participants; very low certainty evidence); All-cause mortality at 30 days For all-cause mortality at 30 days, there is probably no difference between blood products (plasma:platelets:RBCs) transfused in a 1:1:1 ratio versus a 1:1:2 ratio (RR 0.85, 95% CI 0.65 to 1.11; 1 study, 680 participants; moderate-certainty evidence). There may be little to no difference between the following interventions in all-cause mortality at 30 days: • cryoprecipitate plus MHP versus MHP alone (RR 0.77, 95% CI 0.33 to 1.78; 2 studies, 1572 participants; low-certainty evidence); and •leucoreduced RBCs versus standard RBCs (RR 1.20, 95% CI 0.74 to 1.95; 1 study,55 participants; low certainty evidence). We are uncertain of the effect on all-cause mortality at 30 days for: •lyophilised plasma versus FFP (RR 0.75, 95% CI 0.28 to 2.02; 1 study, 47 participants; very low certainty evidence); and • blood products (plasma:platelets:RBCs) transfused in 1:1:1 ratio versus standard MHP (RR 2.25, 95% CI 0.90 to 5.62; 1 study, 69 participants; very low certainty evidence). Total number of thromboembolic events at 30 days There may be little to no difference between the following interventions for total thromboembolic events at 30 days: • cryoprecipitate plus MHP versus MHP alone (RR 0.55, 95% CI 0.08 to 3.72; 2 studies, 1645 participants; low-certainty evidence); and • blood products (plasma:platelets:RBCs) transfused in 1:1:1 ratio versus 1:1:2 ratio (RR 1.03, 95% CI 0.75 to 1.42; 1 study, 680 participants; low-certainty evidence). We are uncertain of the effect on the total number of thromboembolic events at 30 days for: •blood products (plasma:platelets:RBCs) transfused in 1:1:1 ratio versus standard MHP (POR 6.83, 95% CI 0.68 to 68.35; 1 study, 69 participants; very low certainty evidence). Comparison 3: Whole blood versus individual blood products We are uncertain of the effect of modified (leucoreduced) whole blood versus blood products (RBCs:plasma) transfused in a 1:1 ratio on all-cause mortality at 24 hours (RR 1.13, 95% CI 0.37 to 3.49) or 30 days (RR 1.62, 95% CI 0.69 to 3.80) (1 study, 107 participants; very low certainty evidence). Comparison 4: Goal-directed blood transfusion strategy of viscoelastic haemostatic assay (VHA) versus conventional laboratory coagulation tests (CCT) to guide haemostatic therapy There may be little or no difference in all-cause mortality at 24 hours between VHA and CCT (RR 0.85, 95% CI 0.54 to 1.35; 1 study, 396 participants; low-certainty evidence). We are uncertain of the effects on all-cause mortality at 30 days (RR 0.75, 95% CI 0.48 to 1.17; 2 studies, 506 participants; very low certainty evidence). There is probably no difference between VHA and CCT in total thromboembolic events at 30 days (RR 0.65, 95% CI 0.35 to 1.18; 1 study 396 participants; moderate-certainty evidence).

AUTHORS' CONCLUSIONS: Overall, there was little to no evidence of a difference between blood transfusion strategies for mortality or thromboembolic events. The studies covered a wide range of interventions, and the comparators and standard of care practice varied between trials, thereby limiting the pooling of data. Further research is needed.

摘要

背景

创伤是全球发病和死亡的主要原因。研究表明,如果早期识别并治疗,出血和创伤性凝血病是创伤性损伤的可逆组成部分。在定义和输血策略上缺乏共识阻碍了将这一证据转化为临床实践。

目的

评估在创伤后24小时内开始的输血策略对有大出血的成人(16岁及以上)的有益和有害影响。

检索方法

于2023年11月20日检索了CENTRAL、MEDLINE、Embase、其他五个数据库以及三个试验注册库。我们还检查了纳入研究的参考文献列表以识别任何其他研究。

选择标准

我们纳入了关于16岁及以上成人在创伤后24小时内接受血液制品以管理出血的随机对照试验(RCT)。

数据收集与分析

我们使用标准的Cochrane方法进行综述,并使用GRADE评估证据的确定性。

主要结果

我们纳入了18项RCT,共5041名参与者。比较1:院前输血策略 五项研究比较了血浆(新鲜冰冻血浆(FFP)或冻干血浆)与“标准治疗”的使用情况。我们不确定血浆对24小时全因死亡率的影响(风险比(RR)1.05,95%置信区间(CI)0.48至2.30;3项研究,279名参与者;极低确定性证据)。血浆与标准治疗在30天全因死亡率上可能没有差异(RR 0.95,95%CI 0.78至1.17;3项研究,664名参与者;中度确定性证据)。然而,一项无法纳入我们荟萃分析的整群RCT结果表明,血浆可能与30天死亡风险较低相关(RR 0.54,95%CI 0.42至0.70;1项研究,481名参与者;低确定性证据)。血浆与标准治疗在30天血栓栓塞事件总数上可能没有差异(RR 1.23,95%CI 0.67至2.27;4项研究,586名参与者;低确定性证据)。比较2:院内输血策略 十项研究评估了这一比较,七项提供了可用数据。这些研究评估了冷沉淀(三项研究);固定比例血液成分输血(三项研究);新鲜冰冻血浆(FFP)(一项研究);冻干血浆(一项研究);白细胞滤除红细胞(一项研究);以及限制性输血策略(一项研究)。24小时全因死亡率 对于24小时全因死亡率,以下情况之间可能没有差异:• 冷沉淀加大出血方案(MHP)与单独的MHP相比(RR 0.92,95%CI 从0.70至1.21;1项研究,1577名参与者;中度确定性证据);以及• 以1:1:1比例输注血液制品(血浆:血小板:红细胞(RBC))与1:1:2比例相比(RR 0.75,95%CI 0.52至1.08;1项研究,680名参与者;中度确定性证据)。我们不确定以下情况对24小时全因死亡率的影响:• 以1:1比例输注血液制品(RBC:FFP)与根据凝血和全血细胞计数结果进行输血相比(Peto比值比(POR)0.45,0.17至1.22;一项研究,434名参与者;极低确定性证据);以及• 冻干(FlyP)血浆与FFP相比(POR 1.04,95%CI 0.06至17.23;一项研究,47名参与者;极低确定性证据);30天全因死亡率 对于30天全因死亡率,以1:1:1比例输注血液制品(血浆:血小板:RBC)与1:1:2比例相比可能没有差异(RR 0.85,95%CI 0.65至1.11;1项研究,680名参与者;中度确定性证据)。以下干预措施在30天全因死亡率上可能几乎没有差异:• 冷沉淀加MHP与单独的MHP相比(RR 0.77,95%CI 0.33至1.78;2项研究,1572名参与者;低确定性证据);以及• 白细胞滤除红细胞与标准红细胞相比(RR 1.20,95%CI 0.74至1.95;1项研究,55名参与者;低确定性证据)。我们不确定以下情况对30天全因死亡率的影响:• 冻干血浆与FFP相比(RR 0.75,95%CI 0.28至2.02;1项研究,47名参与者;极低确定性证据);以及• 以1:1:1比例输注血液制品(血浆:血小板:RBC)与标准MHP相比(RR 2.25,95%CI 0.90至5.62;1项研究,69名参与者;极低确定性证据)。30天血栓栓塞事件总数 以下干预措施在30天血栓栓塞事件总数上可能几乎没有差异:• 冷沉淀加MHP与单独的MHP相比(RR 0.55,95%CI 0.08至3.72;2项研究,1645名参与者;低确定性证据);以及• 以1:1:1比例输注血液制品(血浆:血小板:RBC)与1:1:2比例相比(RR 1.03,95%CI 0.75至1.42;1项研究,680名参与者;低确定性证据)。我们不确定以下情况对30天血栓栓塞事件总数的影响:• 以1:1:1比例输注血液制品(血浆:血小板:RBC)与标准MHP相比(POR 6.83,95%CI 0.68至68.35;1项研究,69名参与者;极低确定性证据)。比较3:全血与单个血液制品 我们不确定改良(白细胞滤除)全血与以1:1比例输注的血液制品(RBC:血浆)对24小时(RR 1.13,95%CI 0.37至3.49)或30天(RR 1.62,95%CI 0.69至3.80)全因死亡率的影响(1项研究,107名参与者;极低确定性证据)。比较4:基于粘弹性止血测定(VHA)的目标导向输血策略与传统实验室凝血试验(CCT)以指导止血治疗 在24小时全因死亡率方面,VHA与CCT之间可能几乎没有差异(RR 0.85,95%CI 0.54至1.35;1项研究,396名参与者;低确定性证据)。我们不确定其对30天全因死亡率的影响(RR 0.75,95%CI 0.48至1.17;2项研究,506名参与者;极低确定性证据)。在30天血栓栓塞事件总数方面,VHA与CCT之间可能没有差异(RR 0.65,95%CI 0.35至1.18;1项研究,396名参与者;中度确定性证据)。

作者结论

总体而言,几乎没有证据表明输血策略在死亡率或血栓栓塞事件方面存在差异。这些研究涵盖了广泛的干预措施,且各试验中的对照和标准治疗实践各不相同,从而限制了数据的汇总。需要进一步的研究。

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