IMPORTANCE Traumatic brain injury (TBI) is the leading cause of death and disability due to trauma. Early administration of tranexamic acid may benefit patients with TBI.OBJECTIVE To determine whether tranexamic acid treatment initiated in the out-of-hospital setting within 2 hours of injury improves neurologic outcome in patients with moderate or severe TBI. DESIGN, SETTING, AND PARTICIPANTS Multicenter, double-blinded, randomized clinical trial at 20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017. Eligible participants (N = 1280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher. INTERVENTIONS Three interventions were evaluated, with treatment initiated within 2 hours of TBI: out-of-hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n = 312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n = 345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n = 309). MAIN OUTCOMES AND MEASURESThe primary outcome was favorable neurologic function at 6 months (Glasgow Outcome Scale-Extended score >4 [moderate disability or good recovery]) in the combined tranexamic acid group vs the placebo group. Asymmetric significance thresholds were set at 0.1 for benefit and 0.025 for harm. There were 18 secondary end points, of which 5 are reported in this article: 28-day mortality, 6-month Disability Rating Scale score (range, 0 [no disability] to 30 [death]), progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events. RESULTS Among 1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 [74%] male participants; mean Glasgow Coma Scale score, 8). Of these participants, 819 (84.8%) were available for primary outcome analysis at 6-month followup. The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%; [90% 1-sided confidence limit for benefit, −0.9%]; P = .16; [97.5% 1-sided confidence limit for harm, 10.2%]; P = .84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, −2.9% [95% CI, −7.9% to 2.1%]; P = .26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, −0.9 [95% CI, −2.5 to 0.7]; P = .29), or progression of intracranial hemorrhage (16% vs 20%; difference, −5.4% [95% CI, −12.8% to 2.1%]; P = .16).CONCLUSIONS AND RELEVANCE Among patients with moderate to severe TBI, out-of-hospital tranexamic acid administration within 2 hours of injury compared with placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Ou...
Access to high quality acute trauma care is well established across parts of Canada but a clear urban/rural divide persists. Regional efforts to improve short- and long-term outcomes after severe trauma should focus on the optimization of access to pre-hospital care and acute trauma care in rural communities using locally relevant strategies or novel care delivery options.
Objectives:To examine the safety of emergency department (ED) procedural sedation and analgesia (PSA) and the patterns of use of pharmacologic agents at a Canadian adult teaching hospital. Methods: Retrospective analysis of the PSA records of 979 patients, treated between Aug. 1, 2004, and July 31, 2005, with descriptive statistical analysis. This represents an inclusive consecutive case series of all PSAs performed during the study period. Results: Hypotension (systolic blood pressure ≤ 85 mm Hg) was documented during PSA in 13 of 979 patients (1.3%; 95% confidence interval [CI] 0.3%-2.3%), and desaturation (SaO 2 ≤ 90) in 14 of 979 (1.4%; CI 0.1%-2.7%). No cases of aspiration, endotracheal intubation or death were recorded. The most common medication used was fentanyl (94.0% of cases), followed by propofol (61.2%), midazolam (42.5%) and then ketamine (2.7%). The most frequently used 2-medication combinations were propofol and fentanyl (P/F) followed by midazolam and fentanyl (M/F), used with similar frequencies 58.1% (569/979) and 41.0% (401/979) respectively. There was no significant difference in the incidence of hypotension or desaturation between the P/F and M/F treated groups. In these patients, 9.1% (90/979) of patients received more than 2 different drugs. Conclusions: Adverse events during ED PSA are rare and of doubtful clinical significance. Propofol/fentanyl and midazolam/fentanyl are used safely, and at similar frequencies for ED PSA in this tertiary hospital case series. The use of ketamine for adult PSA is unusual in our facility.
An interdisciplinary expert panel of medical and surgical specialists involved in the management of patients with potential spinal cord injuries (SCI) was assembled. Four key questions were created that were of significant interest. These were: (1) what is the optimal type and duration of pre-hospital spinal immobilization in patients with acute SCI?; (2) during airway manipulation in the pre-hospital setting, what is the ideal method of spinal immobilization?; (3) what is the impact of pre-hospital transport time to definitive care on the outcomes of patients with acute spinal cord injury?; and (4) what is the role of pre-hospital care providers in cervical spine clearance and immobilization? A systematic review utilizing multiple databases was performed to determine the current evidence about the specific questions, and each article was independently reviewed and assessed by two reviewers based on inclusion and exclusion criteria. Guidelines were then created related to the questions by a national Canadian expert panel using the Delphi method for reviewing the evidence-based guidelines about each question. Recommendations about the key questions included: the pre-hospital immobilization of patients using a cervical collar, head immobilization, and a spinal board; utilization of padded boards or inflatable bean bag boards to reduce pressure; transfer of patients off of spine boards as soon as feasible, including transfer of patients off spinal boards while awaiting transfer from one hospital institution to another hospital center for definitive care; inclusion of manual in-line cervical spine traction for airway management in patients requiring intubation in the pre-hospital setting; transport of patients with acute traumatic SCI to the definitive hospital center for care within 24 h of injury; and training of emergency medical personnel in the pre-hospital setting to apply criteria to clear patients of cervical spinal injuries, and immobilize patients suspected of having cervical spinal injury.
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