TY - JOUR
T1 - RePHILL
T2 - Protocol for a randomised controlled trial of pre-hospital blood product resuscitation for trauma
AU - Smith, Iain M
AU - Crombie, Nicholas
AU - Bishop, Jonathan R B
AU - McLaughlin, Aisling
AU - Naumann, David
AU - Hancox, James
AU - Slinn, Gemma
AU - Ives, Natalie
AU - Grant, Margaret
AU - Perkins, Gavin D
AU - Doughty, Heidi
AU - Midwinter, Mark
PY - 2018/10
Y1 - 2018/10
N2 - 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.
AB - 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.
KW - Wounds and Injuries
KW - Haemorrhage
KW - Emergency Medical Services
KW - Blood Transfusion
KW - Randomised Controlled Trial
U2 - 10.1111/tme.12486
DO - 10.1111/tme.12486
M3 - Article
SN - 0958-7578
VL - 28
SP - 346
EP - 356
JO - Transfusion Medicine
JF - Transfusion Medicine
IS - 5
ER -