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

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. and Midwinter, M. J. (2017) RePHILL: protocol for a randomised controlled trial of pre-hospital blood product resuscitation for trauma. Transfusion Medicine (Oxford, England), . doi:10.1111/tme.12486

Author 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.
Title RePHILL: protocol for a randomised controlled trial of pre-hospital blood product resuscitation for trauma
Journal name Transfusion Medicine (Oxford, England)   Check publisher's open access policy
ISSN 1365-3148
Publication date 2017-11-28
Year available 2017
Sub-type Article (original research)
DOI 10.1111/tme.12486
Open Access Status Not yet assessed
Total pages 11
Place of publication West Sussex, United Kingdom
Publisher Wiley-Blackwell Publishing
Abstract 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.

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.

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.

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.

RePHILL will provide high-quality evidence regarding the efficacy and safety of PHBP resuscitation for trauma.
Keyword blood transfusion
emergency medical services
randomised controlled trial
wounds and injuries
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: HERDC Pre-Audit
School of Biomedical Sciences Publications
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Created: Wed, 10 Jan 2018, 14:00:29 EST