Expedited transfer from the scene for refractory out-of-hospital cardiac arrest in Australia: a prospective, multicentre, parallel, open label, randomised clinical trial.

We aimed to determine whether expedited intra-arrest transfer to hospital in adults with refractory OHCA improves favourable neurological outcomes.

我们旨在确定对于难治性OHCA的成年患者，是否加速转运至医院能够改善良好的神经系统预后。

Methods

We conducted a prospective, parallel, multi-centre, open-label randomised, superiority trial across greater Sydney, NSW, Australia.

我们在澳大利亚新南威尔士州的大悉尼地区进行了一项前瞻性、平行、多中心、开放标签的随机优越性试验。

Patients aged 18-70 years with a witnessed OHCA of presumed medical cause, bystander cardiopulmonary resuscitation (CPR), and an initial shockable rhythm or pulseless electrical activity without return of spontaneous circulation after 15 mins of advanced life support or three rounds of professional resuscitation were randomly assigned (1:1) at the scene by New South Wales Ambulance paramedics using a secure online randomisation system.

年龄在18-70岁之间，有目击的院外心脏骤停（OHCA）且原因被认为是医疗性的患者，旁观者进行了心肺复苏（CPR），并且初始可除颤心律或无脉性电活动，在经过15分钟的高级生命支持或三次专业复苏后没有恢复自主循环，这些患者在现场由新南威尔士州救护车的医务人员使用安全的在线随机系统随机分配（1:1）。

Masking of allocation from ambulance staff and hospital staff receiving the patients was not possible.

无法实现对救护车工作人员和接收患者的医院工作人员进行分配的掩蔽。

The intervention consisted of a predefined expedited bundle of pre-hospital care followed by intra-arrest transport with mechanical compression to a cardiac catheterisation centre (15 receiving hospitals) for immediate assessment for coronary angiography, extracorporeal cardiopulmonary resuscitation (ECPR), or both.

干预措施包括一系列预先定义的急救护理措施，随后进行院内心脏骤停的转运，使用机械压迫方式转运至心脏导管中心（15家接收医院），以便立即进行冠状动脉造影、体外心肺复苏（ECPR）或两者兼施。

The control arm consisted of a standard transport strategy of more extended on-scene advanced life support before considering transport and the same therapies.

对照组采用了一种标准的转运策略，即在考虑转运之前进行更长时间的现场高级生命支持，并采用相同的治疗方法。

The primary outcome was survival with a good neurological outcome (defined as Cerebral Performance Category [CPC] score of 1-2) at hospital discharge, stratified by initial rhythm.

主要结果是出院时具有良好神经功能的结果（定义为脑功能类别[CPC]评分为1-2），并根据初始节律进行分层。

Patients were followed-up until death or for 6 months (last patient followed-up Aug 29, 2024).

患者随访至死亡或6个月（最后一名患者随访至2024年8月29日）。

All analyses were done on an intention-to-treatbasis.

所有分析均基于意向治疗原则进行。

The trial was prospectively registered with the Australian Clinical Trials Registry, ACTRN12621000668808 and is now complete.

该试验已在澳大利亚临床试验注册处前瞻性注册，注册号为ACTRN12621000668808，目前已完成。

Data on safety and adverse events were collected throughout the study period and reported to a data safety monitoring board on a 6 monthly basis.

在整个研究期间收集了关于安全性和不良事件的数据，并每六个月向数据安全监测委员会报告一次。

Results

Between July 15, 2021 and March 3, 2024, we enrolled 206 patients.

2021年7月15日至2024年3月3日期间，我们共招募了206名患者。

Eight patients were later deemed to be ineligible and one patient was excluded due to a randomisation application failure. 197 patients were therefore enrolled; 102 to the expedited strategy (intervention) and 95 to the standard strategy (control).

后来有8名患者被认为不符合资格，另有1名患者因随机化申请失败被排除。因此，共有197名患者被纳入研究；其中102名患者接受加速策略（干预组），95名患者接受标准策略（对照组）。

The median age was 57·0 years (range 47-64); 161 (82%) were men and 78 (40%) were White.

中位年龄为57.0岁（范围47-64岁）；161名（82%）为男性，78名（40%）为白人。

At hospital discharge, 15 (15%) of 102 patients in the expedited transportation group were alive with a favourable neurological outcome, compared with 15 (16%) of 95 patients in the standard care group (risk difference -1·1% [95% CI -12·2% to 10·0%]; adjusted relative risk 0·95 [95% CI 0·50 to 1·8], p=0·87). 38 patients had a serious adverse event(19%)-35 (92%) were diagnosed with a hypoxic brain injury (17 [49%] in the expedited arm, 18 [51%] in the standard arm), one (3%) had a cerebral stroke, one (3%) had a pulmonary haemorrhage, and one (3%) had a gastrointestinal haemorrhage (all in the standard arm).

在出院时，102名患者中，有15名（15%）在快速转运组的患者存活并具有良好的神经系统结果，而在标准护理组的95名患者中，有15名（16%）具有良好的神经系统结果（风险差异-1.1% [95% 置信区间 -12.2% 至 10.0%]；调整后的相对风险为0.95 [95% 置信区间 0.50 至 1.8]，p=0.87）。有38名患者发生了严重不良事件（19%）-35名（92%）被诊断为缺氧性脑损伤（快速转运组17名，标准护理组18名），一名（3%）患有脑卒中，一名（3%）患有肺出血，一名（3%）患有胃肠道出血（均在标准护理组）。

Adverse events were evenly distributed between treatment arms.

不良事件在治疗组之间均匀分布。

No unanticipated (ie, expected sequelae seen in a cardiac arrest trial or in intensive care) adverse events were identified.

未识别出任何未预料到的（即，在心脏骤停试验或重症监护中预期的后果）不良事件。

interpretation

Among patients with refractory out-of-hospital cardiac arrest, expedited intra-arrest transport did not significantly improve survival with neurologically favourable outcome.

在难治性院外心脏骤停患者中，加快心搏骤停期间的转运并没有显著改善神经功能良好的生存率。

However, the study might have been underpowered to detect a smaller than expected treatment effect.

然而，该研究可能因样本量不足而未能检测到比预期更小的治疗效果。

funding

New South Wales Health Translational Research Grant Scheme (H20/93572).

新南威尔士州卫生部转化研究资助计划（H20/93572）。