RePHILL: Protocol for a randomised controlled trial of pre-hospital blood product resuscitation for trauma
Research output: Contribution to journal › Article › peer-review
Colleges, School and Institutes
- University Hospital Birmingham Foundation NHS Trust
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.
|Early online date||28 Nov 2017|
|Publication status||Published - Oct 2018|
- Wounds and Injuries, Haemorrhage, Emergency Medical Services, Blood Transfusion, Randomised Controlled Trial