RePHILL：创伤院前血液制品复苏随机对照试验方案

RePHILL: protocol for a randomised controlled trial of pre-hospital blood product resuscitation for trauma.

作者信息

Smith I M, Crombie N, Bishop J R, McLaughlin A, Naumann D N, Herbert M, Hancox J M, Slinn G, Ives N, Grant M, Perkins G D, Doughty H, Midwinter M J

机构信息

NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK.

Department of Anaesthesia, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.

出版信息

Transfus Med. 2018 Oct;28(5):346-356. doi: 10.1111/tme.12486. Epub 2017 Nov 28.

DOI:10.1111/tme.12486

PMID:29193548

Abstract

OBJECTIVES

To describe the 'Resuscitation with Pre-HospItaL bLood products' trial (RePHILL) - a multi-centre randomised controlled trial of pre-hospital blood product (PHBP) administration vs standard care for traumatic haemorrhage.

BACKGROUND

PHBP are increasingly used for pre-hospital trauma resuscitation despite a lack of robust evidence demonstrating superiority over crystalloids. Provision of PHBP carries additional logistical and regulatory implications, and requires a sustainable supply of universal blood components.

METHODS

RePHILL is a multi-centre, two-arm, parallel group, open-label, phase III randomised controlled trial currently underway in the UK. Patients attended by a pre-hospital emergency medical team, with traumatic injury and hypotension (systolic blood pressure <90 mmHg or absent radial pulse) believed to be due to traumatic haemorrhage are eligible. Exclusion criteria include age <16 years, blood product receipt on scene prior to randomisation, Advanced Medical Directive forbidding blood product administration, pregnancy, isolated head injury and prisoners. A total of 490 patients will be recruited in a 1 : 1 ratio to receive either the intervention (up to two units of red blood cells and two units of lyophilised plasma) or the control (up to four boluses of 250 mL 0.9% saline). The primary outcome measure is a composite of failure to achieve lactate clearance of ≥20%/h over the first 2 hours after randomisation and all-cause mortality between recruitment and discharge from the primary receiving facility to non-acute care. Secondary outcomes include pre-hospital time, coagulation indices, in-hospital transfusion requirements and morbidity.

RESULTS

Pilot study recruitment began in December 2016. Approval to proceed to the main trial was received in June 2017. Recruitment is expected to continue until 2020.

CONCLUSIONS

RePHILL will provide high-quality evidence regarding the efficacy and safety of PHBP resuscitation for trauma.

摘要

目的

描述“院前血液制品复苏”试验（RePHILL）——一项关于院前血液制品（PHBP）输注与创伤性出血标准治疗的多中心随机对照试验。

背景

尽管缺乏有力证据表明PHBP优于晶体液，但PHBP在院前创伤复苏中的应用越来越广泛。提供PHBP带来了额外的后勤和监管问题，并且需要可持续供应通用血液成分。

方法

RePHILL是一项多中心、双臂、平行组、开放标签的III期随机对照试验，目前正在英国进行。由院前紧急医疗团队接诊、有创伤性损伤且低血压（收缩压<90 mmHg或桡动脉搏动消失）且认为是由创伤性出血所致的患者符合条件。排除标准包括年龄<16岁、随机分组前在现场接受血液制品、有禁止输注血液制品的预立医疗指示、怀孕、单纯性头部损伤和囚犯。总共将按1∶1的比例招募490例患者，分别接受干预措施（最多两单位红细胞和两单位冻干血浆）或对照措施（最多四次250 mL 0.9%生理盐水推注）。主要结局指标是随机分组后最初2小时内乳酸清除率未达到≥20%/小时以及从主要接收机构招募到出院至非急症护理期间的全因死亡率的复合指标。次要结局包括院前时间、凝血指标、院内输血需求和发病率。