Resuscitation with pre-hospital blood products in adults with trauma-related haemorrhagic shock: the RePHILL RCT
Author
Crombie, NicholasDoughty, Heidi A
Bishop, Jonathan
Desai, Amisha
Dixon, Emily
Hancox, James
Herbert, Mike J
Leech, Caroline
Lewis, Simon J
Nash, Mark
Naumann, David
Piper, Karen
Slinn, Gemma
Smith, Hazel
Smith, Iain M
Wale, Rebekah
Wilson, Alastair
Crombie, Aisling
Midwinter, Mark
Ives, Natalie
Perkins, Gavin
Publication date
2024-01Subject
Practice of medicine
Metadata
Show full item recordAbstract
Background: The treatment of traumatic haemorrhagic shock has been transformed through better haemorrhage control, use of tranexamic acid and use of blood products. The improved survival seen from these strategies has stimulated an interest in pre-hospital transfusion. Objectives: To determine if the clinical effectiveness of resuscitation with red blood cells and lyophilised plasma was superior to 0.9% saline for improving tissue perfusion and reducing mortality in adults with haemorrhagic shock following major trauma. Design: A multi-centre, allocation concealed, open-label, parallel group, randomised controlled trial (with internal pilot). Setting: The trial was conducted in four civilian pre-hospital critical care services who operated within the National Health Service (NHS) England Major Trauma Networks. Participants: Adults (aged ≥16 years) who had sustained traumatic injuries, were attended by a pre-hospital emergency medical team and were hypotensive (systolic blood pressure <90 mmHg or absence of radial pulse) as a consequence of traumatic haemorrhage were eligible for inclusion. The exclusion criteria were known or apparently <16 years, blood administered on scene prior to arrival of the RePHILL team, traumatic cardiac arrest where (1) the arrest occurred prior to arrival of the team and/or (2) the primary cause is not hypovolaemia, refusal of blood product administration, known Jehovah’s Witness, pregnancy, isolated head injury without evidence of external haemorrhage, prisoners in the custody of HM Prison and Probation Service. Interventions: Participants were randomised to receive up to either two units each of red blood cells and lyophilised plasma or up to 1 L 0.9% saline. Treatment was administered through the intravenous or intraosseous route. Main outcome measures: The primary outcome was a composite of episode mortality and/or impaired lactate clearance. The secondary outcomes included the individual components of the primary outcome. Results: From 6 December 2016 to 2 January 2021, pre-hospital medical teams randomised 432 participants to red blood cell/lyophilised plasma (n = 209) or 0.9% saline (n = 223) out of a target sample size of 490. Most participants were white (62%), males (82%), median age 38 (interquartile range 26 to 58), involved in a road traffic collision (62%) with severe injuries (median injury severity score 36, interquartile range 25 to 50). Prior to randomisation participants had received on average 430 ml crystalloid fluids and tranexamic acid (90%). The primary outcome occurred in 128/199 (64.3%) of participants randomised to red blood cell/lyophilised plasma and 136/210 (64.8%) randomised to 0.9% saline [adjusted risk difference –0.025% (95% confidence interval –9.0% to 9.0%), p = 0.996]. The event rates for the individual components of the primary outcome, episode mortality and lactate clearance were not statistically different between groups [adjusted average differences −3% (−12% to 7%); p = 0.57 and −5% (−14% to 5%), p = 0.33, respectively]. Limitations: Recruitment stopped prematurely due to disruption caused by the COVID-19 pandemic. Future work: Identify the characteristics of patients who may benefit from pre-hospital blood products and whether alternative transfusion regimens are superior to standard care. Conclusions: The trial did not demonstrate that pre-hospital red blood cell/lyophilised plasma resuscitation was superior to 0.9% saline for trauma-related haemorrhagic shock.Citation
Crombie N, Doughty HA, Bishop JRB, Desai A, Dixon EF, Hancox JM, Herbert MJ, Leech C, Lewis SJ, Nash MR, Naumann DN, Piper K, Slinn G, Smith H, Smith IM, Wale RK, Wilson A, Crombie A, Midwinter M, Ives N, Perkins GD. Resuscitation with pre-hospital blood products in adults with trauma-related haemorrhagic shock: the RePHILL RCT. Southampton (UK): National Institute for Health and Care Research; 2024 Jan.Type
ArticleAdditional Links
https://www.ncbi.nlm.nih.gov/books/NBK599229/DOI
10.3310/TDNB9214PMID
38224557Publisher
NIHR Journals Libraryae974a485f413a2113503eed53cd6c53
10.3310/TDNB9214