I M Smith1, N Crombie1,2,3,4, J R Bishop1,5, A McLaughlin1, D N Naumann1, M Herbert6, J M Hancox1,4, G Slinn5, N Ives5, M Grant5, G D Perkins3,7,8, H Doughty9, M J Midwinter1,10. 1. NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK. 2. Department of Anaesthesia, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. 3. West Midlands Ambulance Service Medical Emergency Response Incident Team, Brierley Hill, UK. 4. Midlands Air Ambulance, Stourbridge, UK. 5. Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK. 6. Department of Haematology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK. 7. Warwick Clinical Trials Unit, University of Warwick, Coventry, UK. 8. Critical Care Unit, Heart of England NHS Foundation Trust, Birmingham, UK. 9. NHS Blood and Transplant, Birmingham, UK. 10. School of Biomedical Sciences, University of Queensland, Brisbane, Queensland, Australia.
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 theintervention (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.
RCT Entities:
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.
Authors: Marco Tartaglione; Luca Carenzo; Lorenzo Gamberini; Cristian Lupi; Aimone Giugni; Carlo Alberto Mazzoli; Valentina Chiarini; Silvia Cavagna; Davide Allegri; John B Holcomb; David Lockey; Giovanni Sbrana; Giovanni Gordini; Carlo Coniglio Journal: BMJ Open Date: 2022-05-30 Impact factor: 3.006
Authors: David N Naumann; James M Hancox; James Raitt; Iain M Smith; Nicholas Crombie; Heidi Doughty; Gavin D Perkins; Mark J Midwinter Journal: BMJ Open Date: 2018-01-23 Impact factor: 2.692
Authors: J E Griggs; J Jeyanathan; M Joy; M Q Russell; N Durge; D Bootland; S Dunn; E D Sausmarez; G Wareham; A Weaver; R M Lyon Journal: Scand J Trauma Resusc Emerg Med Date: 2018-11-20 Impact factor: 2.953
Authors: Nicholas Crombie; Heidi A Doughty; Jonathan R B Bishop; Amisha Desai; Emily F Dixon; James M Hancox; Mike J Herbert; Caroline Leech; Simon J Lewis; Mark R Nash; David N Naumann; Gemma Slinn; Hazel Smith; Iain M Smith; Rebekah K Wale; Alastair Wilson; Natalie Ives; Gavin D Perkins Journal: Lancet Haematol Date: 2022-03-07 Impact factor: 18.959