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Tranexamic Acid for Traumatic Injury in the Emergency Setting: A Systematic Review and Bias-Adjusted Meta-Analysis of Randomized Controlled Trials
Fouche, P. F., Stein, C., Nichols, M., Meadley, B., Bendall, J. C., Smith, K., Anderson, D., Doi, S. A.
Annals of emergency medicine. 2023
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Editor's Choice
Abstract
STUDY OBJECTIVE Traumatic injury causes a significant number of deaths due to bleeding. Tranexamic acid (TXA), an antifibrinolytic agent, can reduce bleeding in traumatic injuries and potentially enhance outcomes. Previous reviews suggested potential TXA benefits but did not consider the latest trials. METHODS A systematic review and bias-adjusted meta-analysis were performed to assess TXA's effectiveness in emergency traumatic injury settings by pooling estimates from randomized controlled trials. Researchers searched Medline, Embase, and Cochrane Central for randomized controlled trials comparing TXA's effects to a placebo in emergency trauma cases. The primary endpoint was 1-month mortality. The methodological quality of the trials underwent assessment using the MASTER scale, and the meta-analysis applied the quality-effects method to adjust for methodological quality. RESULTS Seven randomized controlled trials met the set criteria. This meta-analysis indicated an 11% decrease in the death risk at 1 month after TXA use (odds ratio [OR] 0.89, 95% confidence interval [CI] 0.84 to 0.95) with a number needed to treat of 61 to avoid 1 additional death. The meta-analysis also revealed reduced 24-hour mortality (OR 0.76, 95% CI 0.65 to 0.88) for TXA. No compelling evidence of increased vascular occlusive events emerged (OR 0.96, 95% CI 0.73 to 1.27). Subgroup analyses highlighted TXA's effectiveness in general trauma versus traumatic brain injury and survival advantages when administered out-of-hospital versus inhospital. CONCLUSIONS This synthesis demonstrates that TXA use for trauma in emergencies leads to a reduction in 1-month mortality, with no significant evidence of problematic vascular occlusive events. Administering TXA in the out-of-hospital setting is associated with reduced mortality compared to inhospital administration, and less mortality with TXA in systemic trauma is noted compared with traumatic brain injury specifically.
PICO Summary
Population
Patients with traumatic injuries in emergency settings (7 randomised controlled trials).
Intervention
Tranexamic acid (TXA).
Comparison
Placebo.
Outcome
The primary endpoint was 1-month mortality. The meta-analysis indicated an 11% decrease in the death risk at 1 month after TXA use (odds ratio [OR] 0.89; 95% confidence interval (CI) [0.84, 0.95]) with a number needed to treat of 61 to avoid 1 additional death. The meta-analysis also revealed reduced 24-hour mortality (OR 0.76; 95% CI [0.65, 0.88]) for TXA. No compelling evidence of increased vascular occlusive events emerged (OR 0.96; 95% CI [0.73, 1.27]). Subgroup analyses highlighted TXA's effectiveness in general trauma versus traumatic brain injury and survival advantages when administered out-of-hospital versus in-hospital.
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Factors that influence the administration of tranexamic acid (TXA) to trauma patients in prehospital settings: a systematic review
Nicholson, H., Scotney, N., Briscoe, S., Kirby, K., Bedson, A., Goodwin, L., Robinson, M., Taylor, H., Thompson Coon, J., Voss, S., et al
BMJ open. 2023;13(5):e073075
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Editor's Choice
Abstract
OBJECTIVE In the UK there are around 5400 deaths annually from injury. Tranexamic acid (TXA) prevents bleeding and has been shown to reduce trauma mortality. However, only 5% of UK major trauma patients who are at risk of haemorrhage receive prehospital TXA. This review aims to examine the evidence regarding factors influencing the prehospital administration of TXA to trauma patients. DESIGN Systematic literature review. DATA SOURCES AMED, CENTRAL, CINAHL, Cochrane Database of Systematic Reviews, Conference Proceedings Citation Index-Science, Embase and MEDLINE were searched from January 2010 to 2020; searches were updated in June 2022. CLINICALTRIALS gov and OpenGrey were also searched and forward and backwards citation chasing performed. ELIGIBILITY CRITERIA All primary research reporting factors influencing TXA administration to trauma patients in the prehospital setting was included. DATA EXTRACTION AND SYNTHESIS Two independent reviewers performed the selection process, quality assessment and data extraction. Data were tabulated, grouped by setting and influencing factor and synthesised narratively. RESULTS Twenty papers (278 249 participants in total) were included in the final synthesis; 13 papers from civilian and 7 from military settings. Thirteen studies were rated as 'moderate' using the Effective Public Health Practice Project Quality Assessment Tool. Several common factors were identified: knowledge and skills; consequences and social influences; injury type (severity, injury site and mechanism); protocols; resources; priorities; patient age; patient sex. CONCLUSIONS This review highlights an absence of high-quality research. Preliminary evidence suggests a host of system and individual-level factors that may be important in determining whether TXA is administered to trauma patients in the prehospital setting. FUNDING AND REGISTRATION This review was supported by Research Capability Funding from the South Western Ambulance Service NHS Foundation Trust and the National Institute for Health Research Applied Research Collaboration South West Peninsula. PROSPERO REGISTRATION NUMBER CRD42020162943.
PICO Summary
Population
Any trauma patients in prehospital settings (20 studies, n= 278,249).
Intervention
Exposure: Factors influencing the decision to administer tranexamic acid (TXA).
Comparison
Outcome
This systematic review included 13 studies from civilian settings and 7 studies from military settings. This review highlighted a lack of high-quality research addressing the factors that influence prehospital TXA administration, particularly in children or patients with isolated head injuries. Common factors identified suggested a host of system and individual-level factors including: knowledge and skills, consequences and social influences, injury type (including severity, injury site and mechanism of injury), protocols, resources, priorities, patient age, and patient sex.
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Effects of tranexamic acid treatment in severely and non-severely injured trauma patients
Ageron FX, Shakur-Still H, Roberts I
Transfusion. 2022
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Editor's Choice
Abstract
BACKGROUND Urgent treatment with tranexamic acid (TXA) reduces bleeding deaths but there is disagreement about which patients should be treated. We examine the effects of TXA treatment in severely and non-severely injured trauma patients. STUDY DESIGN AND METHODS We did an individual patient data meta-analysis of randomized trials with over 1000 trauma patients that assessed the effects of TXA on survival. We defined the severity of injury according to characteristics at first assessment: systolic blood pressure of less than 90 mm Hg and a heart rate greater than 120 beats per minute or Glasgow Coma Scale score of less than nine or any GCS with one or more fixed dilated pupils. The primary measure was survival on the day of the injury. We examined the effect of TXA on survival in severely and non-severely injured patients and how these effects vary with the time from injury to treatment. RESULTS We obtained data for 32,944 patients from two randomized trials. Tranexamic acid significantly increased survival on the day of the injury (OR = 1.22, 95% CI 1.11-1.34; p < .01). The effect of tranexamic acid on survival in non-severely injured patients (OR = 1.25, 1.03-1.50) was similar to that in severely injured patients (OR = 1.22, 1.09-1.37) with no significant heterogeneity (p = .87). In severely and non-severely injured pateints, treatment within the first hour after injury was the most effective. DISCUSSION Early tranexamic acid treatment improves survival in both severely and non-severely injured trauma patients. Its use should not be restricted to the severely injured.
PICO Summary
Population
Severely and non-severely injured trauma patients enrolled in the two large randomised controlled trials: CRASH-2 and CRASH-3 (n= 32,944).
Intervention
Tranexamic acid (n= 16,499).
Comparison
Placebo (n= 16,445).
Outcome
Tranexamic acid significantly increased survival on the day of the injury (odd ratio (OR)= 1.22). The effect of tranexamic acid on survival in non-severely injured patients (OR= 1.25) was similar to that in severely injured patients (OR= 1.22) with no significant heterogeneity. In severely and non-severely injured patients, treatment within the first hour after injury was the most effective.
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The Impact of Pre-Hospital TXA on Mortality among Bleeding Trauma Patients: A Systematic Review and Meta-Analysis
Almuwallad A, Cole E, Ross J, Perkins Z, Davenport R
The journal of trauma and acute care surgery. 2021
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Editor's Choice
Abstract
BACKGROUND Tranexamic acid (TXA) is an antifibrinolytic drug associated with improved survival among trauma patients with haemorrhage. TXA is considered a primary haemostatic intervention in pre-hospital for treatment of bleeding alongside blood product transfusion. METHODS A Systematic Review and Meta-Analysis was conducted to investigate the impact of pre-hospital TXA on mortality among trauma patients with bleeding. A systematic search was conducted using the National Institute for Health and Care Excellence (NICE) Healthcare Databases Advanced Search (HDAS) library which contain the following of databases: EMBASE, Medline, PubMed, BNI, EMCARE, and HMIC. Other databases searched included SCOPUS and the Cochrane Central Register for Clinical Trials Library (CENTRAL). Quality assessment tools were applied among included studies; Cochrane Risk of Bias (ROB) for Randomised Control Trials RCTs and Newcastle-Ottawa Scale (NOS) for cohort observational studies. RESULTS A total of 797 publications were identified from the initial database search. After removing duplicates and applying inclusion/exclusion criteria, Four studies were included in the review and meta-analysis which identified a significant survival benefit in patients who received pre-hospital TXA vs no TXA. Three observational cohort and one RCT were included into the review with a total of 2347 patients (TXA: 1169 vs No TXA: 1178). There was a significant reduction in 24 hours mortality; Odds ratios (OR) 0.60 (95% CI: 0.37-0.99). No Statistical significant differences in 28 to 30 days mortality OR 0.69 (95% CI: 0.47-1.02), or VTE OR 1.49 (95% CI: 0.90 - 2.46) were found. CONCLUSION This review demonstrates that pre-hospital TXA is associated with significant reductions in the early (24 hour) mortality of trauma patients with suspected or confirmed haemorrhage but no increase in the incidence of VTE. LEVEL OF EVIDENCE (I) Systematic review and meta-analysis.
PICO Summary
Population
Trauma patients with bleeding (4 studies, n= 2,347).
Intervention
Prehospital tranexamic acid (TXA, n= 1,169).
Comparison
No TXA (n= 1,178).
Outcome
There was a significant reduction in 24 hour mortality with pre-hospital TXA; (Odds ratios (OR) 0.60.) There were no statistically significant differences in 28 to 30 day mortality (OR 0.69), or VTE (OR 1.49).
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Tranexamic acid is associated with reduced mortality, hemorrhagic expansion, and vascular occlusive events in traumatic brain injury - meta-analysis of randomized controlled trials
July J, Pranata R
BMC Neurol. 2020;20(1):119
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Editor's Choice
Abstract
BACKGROUND This systematic review and meta-analysis aimed to synthesize the latest evidence on the efficacy and safety of tranexamic acid (TXA) on traumatic brain injury (TBI). METHODS We performed a systematic literature search on topics that compared intravenous TXA to placebo in patients with TBI up until January 2020 from several electronic databases. RESULTS There were 30.522 patients from 7 studies. Meta-analysis showed that TXA was associated with reduced mortality (RR 0.92 [0.88, 0.97], p = 0.002; I(2): 0%) and hemorrhagic expansion (RR 0.79 [0.64, 0.97], p = 0.03; I(2): 0%). Both TXA and control group has a similar need for neurosurgical intervention (p = 0.87) and unfavourable Glasgow Outcome Scale (GOS) (p = 0.59). The rate for vascular occlusive events (p = 0.09), and its deep vein thrombosis subgroup (p = 0.23), pulmonary embolism subgroup (p = 1), stroke subgroup (p = 0.38), and myocardial infarction subgroup (p = 0.15) were similar in both groups. Subgroup analysis on RCTs with low risk of bias showed that TXA was associated with reduced mortality and hemorrhagic expansion. TXA was associated with reduced vascular occlusive events (RR 0.85 [0.73, 0.99], p = 0.04; I(2): 4%). GRADE was performed for the RCT with low risk of bias subgroup, it showed a high certainty of evidence for lower mortality, less hemorrhage expansion, and similar need for neurosurgical intervention in TXA group compared to placebo group. CONCLUSION TXA was associated with reduced mortality and hemorrhagic expansion but similar need for neurosurgical intervention and unfavorable GOS. Vascular occlusive events were slightly lower in TXA group on subgroup analysis of RCTs with low risk of bias.
PICO Summary
Population
Traumatic brain injury (TBI) patients (7 studies, n=30522).
Intervention
Tranexamic acid (TXA).
Comparison
Placebo.
Outcome
TXA was associated with reduced mortality and hemorrhagic expansion. Both TXA and control group has a similar need for neurosurgical intervention and unfavourable Glasgow Outcome Scale. The rate for vascular occlusive events, and its deep vein thrombosis subgroup, pulmonary embolism subgroup, stroke subgroup, and myocardial infarction subgroup were similar in both groups. Subgroup analysis on RCTs with low risk of bias showed that TXA was associated with reduced mortality and hemorrhagic expansion. TXA was associated with reduced vascular occlusive events.