Plasma-first resuscitation to treat haemorrhagic shock during emergency ground transportation in an urban area: a randomised trial.

BACKGROUND: Plasma is integral to haemostatic resuscitation after injury, but the timing of administration remains controversial. Anticipating approval of lyophilised plasma by the US Food and Drug Administration, the US Department of Defense funded trials of prehospital plasma resuscitation. We investigated use of prehospital plasma during rapid ground rescue of patients with haemorrhagic shock before arrival at an urban level 1 trauma centre. METHODS: The Control of Major Bleeding After Trauma Trial was a pragmatic, randomised, single-centre trial done at the Denver Health Medical Center (DHMC), which houses the paramedic division for Denver city. Consecutive trauma patients in haemorrhagic shock (defined as systolic blood pressure [SBP] ≤70 mm Hg or 71-90 mm Hg plus heart rate ≥108 beats per min) were assessed for eligibility at the scene of the injury by trained paramedics. Eligible patients were randomly assigned to receive plasma or normal saline (control). Randomisation was achieved by preloading all ambulances with sealed coolers at the start of each shift. Coolers were randomly assigned to groups 1:1 in blocks of 20 according to a schedule generated by the research coordinators. If the coolers contained two units of frozen plasma, they were defrosted in the ambulance and the infusion started. If the coolers contained a dummy load of frozen water, this indicated allocation to the control group and saline was infused. The primary endpoint was mortality within 28 days of injury. Analyses were done in the as-treated population and by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01838863. FINDINGS: From April 1, 2014, to March 31, 2017, paramedics randomly assigned 144 patients to study groups. The as-treated analysis included 125 eligible patients, 65 received plasma and 60 received saline. Median age was 33 years (IQR 25-47) and median New Injury Severity Score was 27 (10-38). 70 (56%) patients required blood transfusions within 6 h of injury. The groups were similar at baseline and had similar transport times (plasma group median 19 min [IQR 16-23] vs control 16 min [14-22]). The groups did not differ in mortality at 28 days (15% in the plasma group vs 10% in the control group, p=0·37). In the intention-to-treat analysis, we saw no significant differences between the groups in safety outcomes and adverse events. Due to the consistent lack of differences in the analyses, the study was stopped for futility after 144 of 150 planned enrolments. INTERPRETATION: During rapid ground rescue to an urban level 1 trauma centre, use of prehospital plasma was not associated with survival benefit. Blood products might be beneficial in settings with longer transport times, but the financial burden would not be justified in an urban environment with short distances to mature trauma centres. FUNDING: US Department of Defense.

Alcohol as a Factor in 911 Calls in Denver.

BACKGROUND: Excessive alcohol consumption is associated with a substantial number of emergency department visits annually and is responsible for a significant number of lives lost each year in the United States. However, a minimal amount is known about the impact of alcohol on the EMS system. OBJECTIVES: The primary objective was to determine the proportion of 9-1-1 calls in Denver, Colorado in which (1) alcohol was a contributing factor or (2) the individual receiving EMS services had recently ingested alcohol. The secondary objectives were to compare the characteristics of EMS calls and to estimate the associated costs. METHODS: This was a prospective observational cohort study of EMS calls for adults from July 1, 2012, to June 30, 2014. Primary outcomes for the study were alcohol as a contributing factor to the EMS call and recent alcohol consumption by the patient receiving EMS services. Logistic regression was utilized to determine the associations between EMS call characteristics and the outcomes. Cost was estimated using historic data. RESULTS: During the study period, 169,642 EMS calls were completed by the Denver Health Paramedic Division. Of these 71% were medical and 29% were trauma-related. The median age was 45 (interquartile range [IQR] 29-59) years, and 55% were male. 50,383 calls (30%) had alcohol consumption, and 49,165 (29%) had alcohol as a contributing factor. Alcohol related calls were associated with male sex, traumatic injuries including head trauma, emergent response, use of airway adjuncts, cardiac monitoring, glucose measurement, use of restraints, use of spinal precautions, and administration of medications for sedation. Estimated costs to the EMS system due to alcohol intoxication exceeded $14 million dollars over the study period and required in excess of 37 thousand hours of paramedic time. CONCLUSIONS: Compared to 9-1-1 calls that do not involve alcohol, alcohol-related calls are more likely to involve male patients, emergent response, traumatic injuries, advanced monitoring, airway adjuncts, and medications for sedation. This represents a significant burden on the emergency system and society. Further studies are needed to evaluate whether additional interventions such as social services could be used to lessen this burden.