Research priorities for the management of major trauma: an international priority setting partnership with the James Lind Alliance.

OBJECTIVE: The objective of this study is to determine research priorities for the management of major trauma, representing the shared priorities of patients, their families, carers and healthcare professionals. DESIGN/SETTING: An international research priority-setting partnership. PARTICIPANTS: People who have experienced major trauma, their carers and relatives, and healthcare professionals involved in treating patients after major trauma. The scope included chest, abdominal and pelvic injuries as well as major bleeding, multiple injuries and those that threaten life or limb. METHODS: A multiphase priority-setting exercise was conducted in partnership with the James Lind Alliance over 24 months (November 2021-October 2023). An international survey asked respondents to submit their research uncertainties which were then combined into several indicative questions. The existing evidence was searched to ensure that the questions had not already been sufficiently answered. A second international survey asked respondents to prioritise the research questions. A final shortlist of 19 questions was taken to a stakeholder workshop, where consensus was reached on the top 10 priorities. RESULTS: A total of 1572 uncertainties, submitted by 417 respondents (including 132 patients and carers), were received during the initial survey. These were refined into 53 unique indicative questions, of which all 53 were judged to be true uncertainties after reviewing the existing evidence. 373 people (including 115 patients and carers) responded to the interim prioritisation survey and 19 questions were taken to a final consensus workshop between patients, carers and healthcare professionals. At the final workshop, a consensus was reached for the ranking of the top 10 questions. CONCLUSIONS: The top 10 research priorities for major trauma include patient-centred questions regarding pain relief and prehospital management, multidisciplinary working, novel technologies, rehabilitation and holistic support. These shared priorities will now be used to guide funders and teams wishing to research major trauma around the globe.

Airway management in patients with suspected or confirmed cervical spine injury: Guidelines from the Difficult Airway Society (DAS), Association of Anaesthetists (AoA), British Society of Orthopaedic Anaesthetists (BSOA), Intensive Care Society (ICS), Neuro Anaesthesia and Critical Care Society (NACCS), Faculty of Prehospital Care and Royal College of Emergency Medicine (RCEM).

BACKGROUND: There are concerns that airway management in patients with suspected or confirmed cervical spine injury may exacerbate an existing neurological deficit, cause a new spinal cord injury or be hazardous due to precautions to avoid neurological injury. However, there are no evidence-based guidelines for practicing clinicians to support safe and effective airway management in this setting. METHODS: An expert multidisciplinary, multi-society working party conducted a systematic review of contemporary literature (January 2012-June 2022), followed by a three-round Delphi process to produce guidelines to improve airway management for patients with suspected or confirmed cervical spine injury. RESULTS: We included 67 articles in the systematic review, and successfully agreed 23 recommendations. Evidence supporting recommendations was generally modest, and only one moderate and two strong recommendations were made. Overall, recommendations highlight key principles and techniques for pre-oxygenation and facemask ventilation; supraglottic airway device use; tracheal intubation; adjuncts during tracheal intubation; cricoid force and external laryngeal manipulation; emergency front-of-neck airway access; awake tracheal intubation; and cervical spine immobilisation. We also signpost to recommendations on pre-hospital care, military settings and principles in human factors. CONCLUSIONS: It is hoped that the pragmatic approach to airway management made within these guidelines will improve the safety and efficacy of airway management in adult patients with suspected or confirmed cervical spine injury.

Shock in Trauma.

Shock is a life-threatening condition of circulatory failure leading to inadequate organ perfusion and tissue oxygenation. In a trauma patient, shock may be due to hypovolemia, cardiogenic, obstructive or distributive causes individually or in combination. The physiological response to major hemorrhage is dependent on a variety of autonomic reflexes, mechanism of injury, bleeding source, and baseline physiology of the patient. This article discusses the common causes of shock and the accompanying physiology, how clinical assessment can support the diagnosis and effective treatment of shock, and the common pitfalls in trauma patients.

Pre-hospital blood products and calcium replacement protocols in UK critical care services: A survey of current practice.

Introduction: In the United Kingdom, prehospital blood products are increasingly carried for the early resuscitation of hypovolaemia in patients who are shocked or in cardiac arrest. There is an association between hypocalcaemia and mortality in trauma patients, but no current national guidelines on the timing or dose of calcium replacement exist. The objective of this study was to establish the availability of prehospital blood products, and the current calcium replacement protocols used by UK prehospital services. Methods: A cross sectional survey of all UK air ambulances and additional prehospital critical care organisations was conducted in April-May 2022 via an on-line questionnaire. The survey asked 11 questions about availability of prehospital blood products, calcium replacement for patients requiring prehospital blood products, and the use of point of care testing. Results: There was a 100% response rate with 20/22 UK air ambulances carrying blood products and five additional prehospital services identified. There were 15 different combinations of prehospital blood products. 23/25 services had a standard operating procedure for the replacement of calcium. This was recommended before any blood product administration in 5 services (22%), during or after the 1st unit in 5 services (22%), during or after the 2nd unit in 6 services (26%) and during or after the 4th unit in 7 services (30%). Only six services carried point of care testing and no services routinely used this to measure calcium levels in patients requiring prehospital blood products. Conclusion: In 2022, 91% of UK air ambulances carry prehospital blood products and there is significant variation between services in the combination of blood products provided. There is no consensus on the timing or dose of calcium replacement. Further prospective research should examine the association between traumatic bleeding and ionized calcium levels before and during blood product transfusion in order to produce more robust guidelines for routine calcium replacement.

Resuscitation with blood products in patients with trauma-related haemorrhagic shock receiving prehospital care (RePHILL): a multicentre, open-label, randomised, controlled, phase 3 trial.

BACKGROUND: Time to treatment matters in traumatic haemorrhage but the optimal prehospital use of blood in major trauma remains uncertain. We investigated whether use of packed red blood cells (PRBC) and lyophilised plasma (LyoPlas) was superior to use of 0·9% sodium chloride for improving tissue perfusion and reducing mortality in trauma-related haemorrhagic shock. METHODS: Resuscitation with pre-hospital blood products (RePHILL) is a multicentre, allocation concealed, open-label, parallel group, randomised, controlled, phase 3 trial done in four civilian prehospital critical care services in the UK. Adults (age ≥16 years) with trauma-related haemorrhagic shock and hypotension (defined as systolic blood pressure <90 mm Hg or absence of palpable radial pulse) were assessed for eligibility by prehospital critial care teams. Eligible participants were randomly assigned to receive either up to two units each of PRBC and LyoPlas or up to 1 L of 0·9% sodium chloride administered through the intravenous or intraosseous route. Sealed treatment packs which were identical in external appearance, containing PRBC-LyoPlas or 0·9% sodium chloride were prepared by blood banks and issued to participating sites according to a randomisation schedule prepared by the co-ordinating centre (1:1 ratio, stratified by site). The primary outcome was a composite of episode mortality or impaired lactate clearance, or both, measured in the intention-to-treat population. This study is completed and registered with ISRCTN.com, ISRCTN62326938. FINDINGS: From Nov 29, 2016 to Jan 2, 2021, prehospital critical care teams randomly assigned 432 participants to PRBC-LyoPlas (n=209) or to 0·9% sodium chloride (n=223). Trial recruitment was stopped before it achieved the intended sample size of 490 participants due to disruption caused by the COVID-19 pandemic. The median follow-up was 9 days (IQR 1 to 34) for participants in the PRBC-LyoPlas group and 7 days (0 to 31) for people in the 0·9% sodium chloride group. Participants were mostly white (62%) and male (82%), had a median age of 38 years (IQR 26 to 58), and were mostly involved in a road traffic collision (62%) with severe injuries (median injury severity score 36, IQR 25 to 50). Before randomisation, participants had received on average 430 mL crystalloid fluids and tranexamic acid (90%). The composite primary outcome occurred in 128 (64%) of 199 participants randomly assigned to PRBC-LyoPlas and 136 (65%) of 210 randomly assigned to 0·9% sodium chloride (adjusted risk difference -0·025% [95% CI -9·0 to 9·0], p=0·996). The rates of transfusion-related complications in the first 24 h after ED arrival were similar across treatment groups (PRBC-LyoPlas 11 [7%] of 148 compared with 0·9% sodium chloride nine [7%] of 137, adjusted relative risk 1·05 [95% CI 0·46-2·42]). Serious adverse events included acute respiratory distress syndrome in nine (6%) of 142 patients in the PRBC-LyoPlas group and three (2%) of 130 in 0·9% sodium chloride group, and two other unexpected serious adverse events, one in the PRBC-LyoPlas (cerebral infarct) and one in the 0·9% sodium chloride group (abnormal liver function test). There were no treatment-related deaths. INTERPRETATION: The trial did not show that prehospital PRBC-LyoPlas resuscitation was superior to 0·9% sodium chloride for adult patients with trauma related haemorrhagic shock. Further research is required to identify the characteristics of patients who might benefit from prehospital transfusion and to identify the optimal outcomes for transfusion trials in major trauma. The decision to commit to routine prehospital transfusion will require careful consideration by all stakeholders. FUNDING: National Institute for Health Research Efficacy and Mechanism Evaluation.

Community emergency medicine throughout the UK and Ireland: a comparison of current national activity.

BACKGROUND: Community emergency medicine (CEM) aims to bring highly skilled, expert medical care to the patient outside of the traditional ED setting. Currently, there are several different CEM models in existence within the UK and Ireland which confer multiple benefits including provision of a senior clinical decision-maker early in the patient's journey, frontloading of time-critical interventions, easing pressure on busy EDs and reducing inpatient bed days. This is achieved through increased community-based management supplemented by utilisation of alternative care pathways. This study aimed to undertake a national comparison of CEM services currently in operation. METHOD: A data collection tool was distributed to CEM services by the Pre-Hospital trainee Operated Research Network in October 2020 which aimed to establish current practice among services in the UK and Ireland. It focused on six key sections: service aims; staffing and training; job tasking and patient selection; funding and vehicles used; equipment and medication; data collection, governance and research activity. RESULTS: Seven services responded from across England, Wales and Ireland. Similarities were found with the aims of each service, staffing structures and operational times. There were large differences in equipment carried, categories of patient targeted and with governance and research activity. CONCLUSION: While some national variations in services are explained by funding and geographical location, this review process revealed several differences in practice under the umbrella term of CEM. A national definition of CEM and its aim, with guidance on scope of practice and measurable outcomes, should be generated to ensure high standard and cost-effective emergency care is delivered in the community.

Use of a modified Delphi process to develop research priorities in major trauma.

PURPOSE: The burden of major trauma within the UK is ever increasing. There is a need to establish research priorities within the field. Delphi methodology can be used to develop consensus opinion amongst a group of stakeholders. This can be used to prioritise clinically relevant, patient-centred research questions to guide future funding allocations. The aim of our study was to identify key future research priorities pertaining to the management of major trauma in the UK. METHODS: A three-phased modified Delphi process was undertaken. Phase 1 involved the submission of research questions by members of the trauma community using an online survey (Phase 1). Phases 2 and 3 involved two consecutive rounds of prioritisation after questions were subdivided into 6 subcategories: Brain Injury, Rehabilitation, Trauma in Older People, Pre-hospital, Interventional, and Miscellaneous (Phases 2 and 3). Cut-off points were agreed by consensus amongst the steering subcommittees. This established a final prioritised list of research questions. RESULTS: In phase 1, 201 questions were submitted by 65 stakeholders. After analysis and with consensus achieved, 186 questions were taken forward for prioritisation in phase 2 with 114 included in phase 3. 56 prioritised major trauma research questions across the 6 categories were identified with a clear focus on long-term patient outcomes. Research priorities across the patient pathway from roadside to rehabilitation were deemed of importance. CONCLUSIONS: Consensus within the major trauma community has identified 56 key research questions across 6 categories. Dissemination of these questions to funding bodies to allow for the development of high-quality research is now required. There is a clear indication for targeted multi-centre multi-disciplinary research in major trauma.

Effect of tranexamic acid on intracranial haemorrhage and infarction in patients with traumatic brain injury: a pre-planned substudy in a sample of CRASH-3 trial patients.

BACKGROUND: Early tranexamic acid (TXA) treatment reduces head injury deaths after traumatic brain injury (TBI). We used brain scans that were acquired as part of the routine clinical practice during the CRASH-3 trial (before unblinding) to examine the mechanism of action of TXA in TBI. Specifically, we explored the potential effects of TXA on intracranial haemorrhage and infarction. METHODS: This is a prospective substudy nested within the CRASH-3 trial, a randomised placebo-controlled trial of TXA (loading dose 1 g over 10 min, then 1 g infusion over 8 hours) in patients with isolated head injury. CRASH-3 trial patients were recruited between July 2012 and January 2019. Participants in the current substudy were a subset of trial patients enrolled at 10 hospitals in the UK and 4 in Malaysia, who had at least one CT head scan performed as part of the routine clinical practice within 28 days of randomisation. The primary outcome was the volume of intraparenchymal haemorrhage (ie, contusion) measured on a CT scan done after randomisation. Secondary outcomes were progressive intracranial haemorrhage (post-randomisation CT shows >25% of volume seen on pre-randomisation CT), new intracranial haemorrhage (any haemorrhage seen on post-randomisation CT but not on pre-randomisation CT), cerebral infarction (any infarction seen on any type of brain scan done post-randomisation, excluding infarction seen pre-randomisation) and intracranial haemorrhage volume (intraparenchymal + intraventricular + subdural + epidural) in those who underwent neurosurgical haemorrhage evacuation. We planned to conduct sensitivity analyses excluding patients who were severely injured at baseline. Dichotomous outcomes were analysed using relative risks (RR) or hazard ratios (HR), and continuous outcomes using a linear mixed model. RESULTS: 1767 patients were included in this substudy. One-third of the patients had a baseline GCS (Glasgow Coma Score) of 3 (n=579) and 24% had unilateral or bilateral unreactive pupils. 46% of patients were scanned pre-randomisation and post-randomisation (n=812/1767), 19% were scanned only pre-randomisation (n=341/1767) and 35% were scanned only post-randomisation (n=614/1767). In all patients, there was no evidence that TXA prevents intraparenchymal haemorrhage expansion (estimate=1.09, 95% CI 0.81 to 1.45) or intracranial haemorrhage expansion in patients who underwent neurosurgical haemorrhage evacuation (n=363) (estimate=0.79, 95% CI 0.57 to 1.11). In patients scanned pre-randomisation and post-randomisation (n=812), there was no evidence that TXA reduces progressive haemorrhage (adjusted RR=0.91, 95% CI 0.74 to 1.13) and new haemorrhage (adjusted RR=0.85, 95% CI 0.72 to 1.01). When patients with unreactive pupils at baseline were excluded, there was evidence that TXA prevents new haemorrhage (adjusted RR=0.80, 95% CI 0.66 to 0.98). In patients scanned post-randomisation (n=1431), there was no evidence of an increase in infarction with TXA (adjusted HR=1.28, 95% CI 0.93 to 1.76). A larger proportion of patients without (vs with) a post-randomisation scan died from head injury (38% vs 19%: RR=1.97, 95% CI 1.66 to 2.34, p<0.0001). CONCLUSION: TXA may prevent new haemorrhage in patients with reactive pupils at baseline. This is consistent with the results of the CRASH-3 trial which found that TXA reduced head injury death in patients with at least one reactive pupil at baseline. However, the large number of patients without post-randomisation scans and the possibility that the availability of scan data depends on whether a patient received TXA, challenges the validity of inferences made using routinely collected scan data. This study highlights the limitations of using routinely collected scan data to examine the effects of TBI treatments. TRIAL REGISTRATION NUMBER: ISRCTN15088122.

Man or machine? An experimental study of prehospital emergency amputation.

OBJECTIVE: Prehospital emergency amputation is a rare procedure, which may be necessary to free a time-critical patient from entrapment. This study aimed to evaluate four techniques of cadaveric lower limb prehospital emergency amputation. METHOD: A guillotine amputation of the distal femur was undertaken in fresh frozen self-donated cadavers. A prehospital doctor conducted a surgical amputation with Gigli saw or hacksaw for bone cuts and firefighters carried out the procedure using the reciprocating saw and Holmatro device. The primary outcome measures were time to full amputation and the number of attempts required. The secondary outcomes were observed quality of skin cut, soft tissue cut and CT assessment of the proximal bone. Observers also noted the potential risks to the rescuer or patient during the procedure. RESULTS: All techniques completed amputation within 91 s. The reciprocating saw was the quickest technique (22 s) but there was significant blood spattering and continuation of the cut to the surface under the leg. The Holmatro device took less than a minute. The quality of the proximal femur was acceptable with all methods, but 5 cm more proximal soft tissue damage was made by the Holmatro device. CONCLUSIONS: Emergency prehospital guillotine amputation of the distal femur can effectively be performed using scalpel and paramedic shears with bone cuts by the Gigli saw or fire service hacksaw. The reciprocating saw could be used to cut bone if no other equipment was available but carried some risks. The Holmatro cutting device is a viable option for a life-threatening entrapment where only firefighters can safely access the patient, but would not be a recommended primary technique for medical staff.