Prehospital Whole Blood in Traumatic Hemorrhage - A Randomized Controlled Trial.

Methods

We conducted a pragmatic, phase 3, multicenter, unblinded, randomized, superiority trial across 10 air ambulance services in England.

我们在英格兰的10个空中救护服务中进行了一项实用的、第3阶段的、多中心的、未设盲的、随机的、优效性试验。

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.

参与的空中救护服务接诊的主要创伤性出血患者被随机分配接受全血输注（最多2单位）或标准护理，即在到达医院前接受最多2单位的红细胞和血浆成分输注。主要结果是随机化后24小时内因任何原因死亡或大量输血（≥10单位血液成分或制品）的复合结果。

Results

A total of 942 patients underwent randomization.

共有942名患者进行了随机化。

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).

在排除了非创伤性出血或创伤性心脏骤停的参与者后，共有616名参与者被纳入分析（全血组314人，标准护理组302人）。

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).

全血组中有48.7%的参与者发生了主要结果事件，而标准护理组中有47.7%的参与者发生了主要结果事件（相对风险，1.02；95%置信区间，0.80至1.31；P = 0.84）。

The incidenceof death from any cause at all time points, massive transfusion, and other secondary outcomes appeared to be similar in the two groups.

在所有时间点上，两组的全因死亡率、大量输血和其他次要结果似乎相似。

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.

在全血组中，40.7%的参与者凝血酶原时间超过正常范围，在标准护理组中这一比例为30.5%。

More serious adverse events occurred in the standard-care group than in the whole-blood group (37 and 31, respectively).

标准护理组中发生的严重不良事件比全血组多（分别为37例和31例）。

The incidenceof thrombotic events appeared to be similar in the two groups.

两组中血栓事件的发生率似乎相似。

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.

在面临生命威胁性出血的参与者中，院前输注2单位全血并不优于标准治疗，以减少24小时内死亡或大量输血的风险。

(Funded by NHS Blood and Transplant and others; ISRCTN Registry number, ISRCTN23657907.).

(该项目由NHS Blood and Transplant等资助；ISRCTN注册号，ISRCTN23657907。)