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[Lancet最新论文]: 紧急地面转运期间首先输注血浆治疗失血性休克
2018年08月12日 时讯速递, 进展交流 暂无评论

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Plasma-first resuscitation to treat haemorrhagic shock during emergency ground transportation in an urban area: a randomised trial

Hunter B Moore, Ernest E Moore, Michael P Chapman, et al

Lancet 2018; 392: 283-291

Summary

Background 背景

Plasma is integral to haemostatic resuscitation after injury, but the timing of administration remains controversial. Anticipating approval of lyophilised plasma by the US Food and Drug Administration, the US Department of Defense funded trials of prehospital plasma resuscitation. We investigated use of prehospital plasma during rapid ground rescue of patients with haemorrhagic shock before arrival at an urban level 1 trauma centre.

输注血浆作为创伤后止血复苏治疗的一部分,其确切时间仍存在疑问。由于预期冻存血浆将获得性美国FDA的批准,美国国防部资助了院前输注血浆进行复苏的临床试验。我们对失血性休克患者到达城市1级创伤中心前在快速地面转运期间院前输注血浆进行了研究。

Methods 方法

The Control of Major Bleeding After Trauma Trial was a pragmatic, randomised, single-centre trial done at the Denver Health Medical Center (DHMC), which houses the paramedic division for Denver city. Consecutive trauma patients in haemorrhagic shock (defined as systolic blood pressure [SBP] ≤70 mm Hg or 71–90 mm Hg plus heart rate ≥108 beats per min) were assessed for eligibility at the scene of the injury by trained paramedics. Eligible patients were randomly assigned to receive plasma or normal saline (control). Randomisation was achieved by preloading all ambulances with sealed coolers at the start of each shift. Coolers were randomly assigned to groups 1:1 in blocks of 20 according to a schedule generated by the research coordinators. If the coolers contained two units of frozen plasma, they were defrosted in the ambulance and the infusion started. If the coolers contained a dummy load of frozen water, this indicated allocation to the control group and saline was infused. The primary endpoint was mortality within 28 days of injury. Analyses were done in the as-treated population and by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01838863.

控制创伤后大出血试验是一项实效性、随机、单中心临床试验,在丹佛健康医学中心进行。丹佛市的医疗辅助救援部门也设置在这家医院。经过培训的医疗辅助人员在创伤现场对于连续收治的失血性休克(定义为收缩压 [SBP] ≤70 mm Hg 或 71–90 mm Hg 且心率 ≥108 bpm)创伤患者进行评估。符合入选标准的患者被随机分组,分别接受血浆输注或生理盐水输注(对照)。每个班次开始时,在所有救护车中准备好经过密封的冷藏箱。根据研究协调人制定的方案,按照1:1的比例,区组大小为20,将冷藏箱随机分组。如果冷藏箱中有2个单位冰冻血浆,则在救护车中进行解冻,并开始输注。如果冷藏箱中仅有冰冻盐水,则提示患者分配至对照组,开始输注生理盐水。主要预后终点为创伤后28天病死率。针对接受治疗人群采用意向治疗分析。试验在ClinicalTrials.gov注册,注册号NCT01838863

Findings 结果

From April 1, 2014, to March 31, 2017, paramedics randomly assigned 144 patients to study groups. The as-treated analysis included 125 eligible patients, 65 received plasma and 60 received saline. Median age was 33 years (IQR 25–47) and median New Injury Severity Score was 27 (10–38). 70 (56%) patients required blood transfusions within 6 h of injury. The groups were similar at baseline and had similar transport times (plasma group median 19 min [IQR 16–23] vs control 16 min [14–22]). The groups did not differ in mortality at 28 days (15% in the plasma group vs 10% in the control group, p=0·37). In the intention-to-treat analysis, we saw no significant differences between the groups in safety outcomes and adverse events. Due to the consistent lack of differences in the analyses, the study was stopped for futility after 144 of 150 planned enrolments.

从2014年4月1日至2017年3月31日,医疗辅助人员将144名患者进行随机分组。接受治疗分析纳入125名患者,其中65名患者接受血浆输注,60名患者接受生理盐水输注。中位年龄33岁(IQR 25–47,新创伤严重程度评分中位数为27 (10–38)。70名 (56%) 患者在创伤后6小时内需要输血。两组患者基线特征相似,转运时间也相似(血浆组中位时间 19 分钟 [IQR 16–23] vs 对照组 16 分钟 [14–22])。两组患者28天病死率没有差异(血浆组 15% vs 对照组 10%,p=0·37)。意向治疗分析中,两组患者安全性预后指标及不良事件并无差异,由于所有分析均未发现任何差异,因此,试验计划入选150名患者,但在入选144名患者后因缺乏疗效试验终止。

Interpretation 结论

During rapid ground rescue to an urban level 1 trauma centre, use of prehospital plasma was not associated with survival benefit. Blood products might be beneficial in settings with longer transport times, but the financial burden would not be justified in an urban environment with short distances to mature trauma centres.

在快速地面转运至城市1级创伤中心过程中,院前输注血浆并不伴有生存获益。在转运时间更长的情况下,血液制品或许有益,但在城市环境中仅需短途转运至有经验的创伤中心时,院前输注血浆的经济负担超过其获益。

Funding

US Department of Defense.

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