近日，英国伦敦玛丽女王大学Laura Green团队报道了院前全血治疗创伤性出血的随机对照试验。相关论文于2026年3月17日发表在《新英格兰医学杂志》上。

全血输注在严重出血救治中的应用近期受到关注，但评估其临床有效性和安全性的大型临床试验数据仍较缺乏。

这项实效性3期多中心非盲随机优效性试验在英国10家空中救护服务机构开展。由参与研究的空中救护服务机构接诊的创伤性大出血患者被随机分配接受院前全血输注（最多2单位）或标准成分血输注（红细胞和血浆各最多2单位）。主要结局为随机分组后24小时内全因死亡或大量输血（输注血液成分或制品≥10单位）的复合终点。

共942例患者接受随机分组。排除非创伤性出血或创伤性心脏骤停患者后，共616例纳入分析（全血组314例，标准治疗组302例）。全血组48.7%的患者发生主要结局事件，标准治疗组为47.7%（相对危险度为1.02；95%置信区间为0.80～1.31；P=0.84）。两组在各时间点全因死亡率、大量输血发生率及其他次要结局方面均未见显著差异。全血组40.7%的患者凝血酶原时间超出正常范围，标准治疗组为30.5%。标准治疗组的严重不良事件（37例）多于全血组（31例）。两组血栓事件发生率未见显著差异。

研究结果表明，在危及生命的出血患者中，院前输注2单位全血在降低24小时内死亡或大量输血风险方面并不优于标准治疗。

附：英文原文

Title: Prehospital Whole Blood in Traumatic Hemorrhage — a Randomized Controlled Trial

Author: Jason E. Smith, Rebecca Cardigan, Emily Sanderson, Laura Silsby, Claire Rourke, Ed B.G. Barnard, Peter Basham, Grazia Antonacci, Richard Charlewood, Nikki Dallas, Jane Davies, Elizabeth Goodwin, Annie Hawton, Cara Hudson, Joanne Lucas, Katie Keen, Richard M. Lyon, Brodie Nolan, Gavin D. Perkins, Viona Rundell, Laura Smith, Simon J. Stanworth, Anne Weaver, Tom Woolley, Laura Green

Issue&Volume: 2026-03-17

Abstract:

Background

Whole-blood transfusion has recently gained favor in the management of severe hemorrhage; however, data from large clinical trials evaluating its clinical effectiveness and safety are lacking.

Methods

We conducted a pragmatic, phase 3, multicenter, unblinded, randomized, superiority trial across 10 air ambulance services in England. Patients with major traumatic hemorrhage who were attended by a participating air ambulance service were randomly assigned to receive either whole-blood transfusion (up to 2 units) or standard care with blood components (up to 2 units each of red cells and plasma) before arrival at the hospital. The primary outcome was a composite of death from any cause or massive transfusion (≥10 units of blood components or products) within 24 hours after randomization.

Results

A total of 942 patients underwent randomization. After the exclusion of participants with nontraumatic hemorrhage or traumatic cardiac arrest, 616 were included in the analysis (314 in the whole-blood group and 302 in the standard-care group). A primary-outcome event occurred in 48.7% of the participants in the whole-blood group and in 47.7% of those in the standard-care group (relative risk, 1.02; 95% confidence interval, 0.80 to 1.31; P=0.84). The incidence of death from any cause at all time points, massive transfusion, and other secondary outcomes appeared to be similar in the two groups. Prothrombin times were above the normal range in 40.7% of the participants in the whole-blood group and in 30.5% of those in the standard-care group. More serious adverse events occurred in the standard-care group than in the whole-blood group (37 and 31, respectively). The incidence of thrombotic events appeared to be similar in the two groups.

Conclusions

Among participants with life-threatening hemorrhage, prehospital transfusion of 2 units of whole blood was not superior to standard care in reducing the risk of death or massive transfusion within 24 hours.

DOI: NJ202603170000005

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2516043