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

Iain M Smith, Nicholas Crombie, Jonathan R B Bishop, Aisling McLaughlin, David Naumann, James Hancox, Gemma Slinn, Natalie Ives, Margaret Grant, Gavin D Perkins, Heidi Doughty, Mark Midwinter

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17 Citations (Scopus)
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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 versus 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<90mmHg 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. 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 4 boluses of 250ml 0.9% saline). The primary outcome measure is a composite of failure to achieve lactate clearance of ≥20% per hour over the first two 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. Conclusions RePHILL will provide high quality evidence regarding the efficacy and safety of PHBP resuscitation for trauma.
Original languageEnglish
Pages (from-to)346-356
JournalTransfusion Medicine
Volume28
Issue number5
Early online date28 Nov 2017
DOIs
Publication statusPublished - Oct 2018

Keywords

  • Wounds and Injuries
  • Haemorrhage
  • Emergency Medical Services
  • Blood Transfusion
  • Randomised Controlled Trial

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