Tranexamic Acid Use in Prehospital Uncontrolled Hemorrhage.
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ABSTRACT:
SUBMITTER: Huebner BR
PROVIDER: S-EPMC5567779 | biostudies-other | 2017 Jun
REPOSITORIES: biostudies-other
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Tranexamic Acid Use in Prehospital Uncontrolled Hemorrhage.
Huebner Benjamin R BR Dorlac Warren C WC Cribari Chris C
Wilderness & environmental medicine 20170601 2S
The use of tranexamic acid (TXA) in the treatment of trauma patients was relatively unexplored until the landmark Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage-2 (CRASH-2) trial in 2010 demonstrated a reduction in mortality with the use of TXA. Although this trial was a randomized, double-blinded, placebo-controlled study incorporating >20,000 patients, numerous limitations and weaknesses have been described. As a result, additional studies have followed, delineating t ...[more]
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Project description:BackgroundGrowing evidence supports improved survival with prehospital blood products. Recent trials show a benefit of prehospital tranexamic acid (TXA) administration in select subgroups. Our objective was to determine if receiving prehospital packed red blood cells (pRBC) in addition to TXA improved survival in injured patients at risk of hemorrhage.MethodsWe performed a secondary analysis of all scene patients from the Study of Tranexamic Acid during Air and ground Medical Prehospital transport trial. Patients were randomized to prehospital TXA or placebo. Some participating EMS services utilized pRBC. Four resuscitation groups resulted: TXA, pRBC, pRBC+TXA, and neither. Our primary outcome was 30-day mortality and secondary outcome was 24-hour mortality. Cox regression tested the association between resuscitation group and mortality while adjusting for confounders.ResultsA total of 763 patients were included. Patients receiving prehospital blood had higher Injury Severity Scores in the pRBC (22 [10, 34]) and pRBC+TXA (22 [17, 36]) groups than the TXA (12 [5, 21]) and neither (10 [4, 20]) groups (p < 0.01). Mortality at 30 days was greatest in the pRBC+TXA and pRBC groups at 18.2% and 28.6% compared with the TXA only and neither groups at 6.6% and 7.4%, respectively. Resuscitation with pRBC+TXA was associated with a 35% reduction in relative hazards of 30-day mortality compared with neither (hazard ratio, 0.65; 95% confidence interval, 0.45-0.94; p = 0.02). No survival benefit was observed in 24-hour mortality for pRBC+TXA, but pRBC alone was associated with a 61% reduction in relative hazards of 24-hour mortality compared with neither (hazard ratio, 0.39; 95% confidence interval, 0.17-0.88; p = 0.02).ConclusionFor injured patients at risk of hemorrhage, prehospital pRBC+TXA is associated with reduced 30-day mortality. Use of pRBC transfusion alone was associated with a reduction in early mortality. Potential synergy appeared only in longer-term mortality and further work to investigate mechanisms of this therapeutic benefit is needed to optimize the prehospital resuscitation of trauma patients.Level of evidenceTherapeutic/Care Management; Level III.
| S-EPMC9233003 | biostudies-literature
Project description:Many trauma systems are examining whether to implement prehospital tranexamic acid (TXA) protocols since hemorrhage remains the leading cause of potentially preventable early trauma mortality, and early in-hospital administration of TXA within 3?hours of injury is associated with reduced mortality. But robust evidence regarding the efficacy of prehospital administration of the antifibrinolytic drug TXA on trauma outcomes is lacking. This review examines the current evidence available regarding prehospital TXA efficacy in both military and civilian trauma, and updates available evidence regarding in-hospital TXA efficacy in trauma.
| S-EPMC5877891 | biostudies-other
Project description:BackgroundEvery 2 minutes, there is a pregnancy-related death worldwide, with one-third caused by severe postpartum hemorrhage. Although international trials demonstrated the efficacy of 1000 mg tranexamic acid in treating postpartum hemorrhage, to the best of our knowledge, there are no dose-finding studies of tranexamic acid on pregnant women for postpartum hemorrhage prevention.ObjectiveThis study aimed to determine the optimal tranexamic acid dose needed to prevent postpartum hemorrhage.Study designWe enrolled 30 pregnant women undergoing scheduled cesarean delivery in an open-label, dose ranging study. Subjects were divided into 3 cohorts receiving 5, 10, or 15 mg/kg (maximum, 1000 mg) of intravenous tranexamic acid at umbilical cord clamping. The inclusion criteria were ≥34 week's gestation and normal renal function. The primary endpoints were pharmacokinetic and pharmacodynamic profiles. Tranexamic acid plasma concentration of >10 μg/mL and maximum lysis of <17% were defined as therapeutic targets independent to the current study. Rotational thromboelastometry of tissue plasminogen activator-spiked samples was used to evaluate pharmacodynamic profiles at time points up to 24 hours after tranexamic acid administration. Safety was assessed by plasma thrombin generation, D-dimer, and tranexamic acid concentrations in breast milk.ResultsThere were no serious adverse events including venous thromboembolism. Plasma concentrations of tranexamic acid increased in a dose-proportional manner. The lowest dose cohort received an average of 448±87 mg tranexamic acid. Plasma tranexamic acid exceeded 10 μg/mL and maximum lysis was <17% at >1 hour after administration for all tranexamic acid doses tested. Median estimated blood loss for cohorts receiving 5, 10, or 15 mg/kg tranexamic acid was 750, 750, and 700 mL, respectively. Plasma thrombin generation did not increase with higher tranexamic acid concentrations. D-dimer changes from baseline were not different among the cohorts. Breast milk tranexamic acid concentrations were 1% or less than maternal plasma concentrations.ConclusionAlthough large randomized trials are necessary to support the clinical efficacy of tranexamic acid for prophylaxis, we propose an optimal dose of 600 mg in future tranexamic acid efficacy studies to prevent postpartum hemorrhage.
| S-EPMC8149481 | biostudies-literature
Project description:ImportanceIn-hospital administration of tranexamic acid after injury improves outcomes in patients at risk for hemorrhage. Data demonstrating the benefit and safety of the pragmatic use of tranexamic acid in the prehospital phase of care are lacking for these patients.ObjectiveTo assess the effectiveness and safety of tranexamic acid administered before hospitalization compared with placebo in injured patients at risk for hemorrhage.Design, setting, and participantsThis pragmatic, phase 3, multicenter, double-blind, placebo-controlled, superiority randomized clinical trial included injured patients with prehospital hypotension (systolic blood pressure ≤90 mm Hg) or tachycardia (heart rate ≥110/min) before arrival at 1 of 4 US level 1 trauma centers, within an estimated 2 hours of injury, from May 1, 2015, through October 31, 2019.InterventionsPatients received 1 g of tranexamic acid before hospitalization (447 patients) or placebo (456 patients) infused for 10 minutes in 100 mL of saline. The randomization scheme used prehospital and in-hospital phase assignments, and patients administered tranexamic acid were allocated to abbreviated, standard, and repeat bolus dosing regimens on trauma center arrival.Main outcomes and measuresThe primary outcome was 30-day all-cause mortality.ResultsIn all, 927 patients (mean [SD] age, 42 [18] years; 686 [74.0%] male) were eligible for prehospital enrollment (460 randomized to tranexamic acid intervention; 467 to placebo intervention). After exclusions, the intention-to-treat study cohort comprised 903 patients: 447 in the tranexamic acid arm and 456 in the placebo arm. Mortality at 30 days was 8.1% in patients receiving tranexamic acid compared with 9.9% in patients receiving placebo (difference, -1.8%; 95% CI, -5.6% to 1.9%; P = .17). Results of Cox proportional hazards regression analysis, accounting for site, verified that randomization to tranexamic acid was not associated with a significant reduction in 30-day mortality (hazard ratio, 0.81; 95% CI, 0.59-1.11, P = .18). Prespecified dosing regimens and post-hoc subgroup analyses found that prehospital tranexamic acid were associated with significantly lower 30-day mortality. When comparing tranexamic acid effect stratified by time to treatment and qualifying shock severity in a post hoc comparison, 30-day mortality was lower when tranexamic acid was administered within 1 hour of injury (4.6% vs 7.6%; difference, -3.0%; 95% CI, -5.7% to -0.3%; P < .002). Patients with severe shock (systolic blood pressure ≤70 mm Hg) who received tranexamic acid demonstrated lower 30-day mortality compared with placebo (18.5% vs 35.5%; difference, -17%; 95% CI, -25.8% to -8.1%; P < .003).Conclusions and relevanceIn injured patients at risk for hemorrhage, tranexamic acid administered before hospitalization did not result in significantly lower 30-day mortality. The prehospital administration of tranexamic acid after injury did not result in a higher incidence of thrombotic complications or adverse events. Tranexamic acid given to injured patients at risk for hemorrhage in the prehospital setting is safe and associated with survival benefit in specific subgroups of patients.Trial registrationClinicalTrials.gov Identifier: NCT02086500.
| S-EPMC7536625 | biostudies-literature
Project description:ImportanceThe development and expansion of intracranial hematoma are associated with adverse outcomes. Use of tranexamic acid might limit intracranial hematoma formation, but its association with outcomes of severe traumatic brain injury (TBI) is unclear.ObjectiveTo assess whether prehospital administration of tranexamic acid is associated with mortality and functional outcomes in a group of patients with severe TBI.Design, setting, and participantsThis multicenter cohort study is an analysis of prospectively collected observational data from the Brain Injury: Prehospital Registry of Outcome, Treatments and Epidemiology of Cerebral Trauma (BRAIN-PROTECT) study in the Netherlands. Patients treated for suspected severe TBI by the Dutch Helicopter Emergency Medical Services between February 2012 and December 2017 were included. Patients were followed up for 1 year after inclusion. Data were analyzed from January 10, 2020, to September 10, 2020.ExposuresAdministration of tranexamic acid during prehospital treatment.Main outcomes and measuresThe primary outcome was 30-day mortality. Secondary outcomes included mortality at 1 year, functional neurological recovery at discharge (measured by Glasgow Outcome Scale), and length of hospital stay. Data were also collected on demographic factors, preinjury medical condition, injury characteristics, operational characteristics, and prehospital vital parameters.ResultsA total of 1827 patients were analyzed, of whom 1283 (70%) were male individuals and the median (interquartile range) age was 45 (23-65) years. In the unadjusted analysis, higher 30-day mortality was observed in patients who received prehospital tranexamic acid (odds ratio [OR], 1.34; 95% CI, 1.16-1.55; P < .001), compared with patients who did not receive prehospital tranexamic acid. After adjustment for confounders, no association between prehospital administration of tranexamic acid and mortality was found across the entire cohort of patients. However, a substantial increase in the odds of 30-day mortality persisted in patients with severe isolated TBI who received prehospital tranexamic acid (OR, 4.49; 95% CI, 1.57-12.87; P = .005) and after multiple imputations (OR, 2.05; 95% CI, 1.22-3.45; P = .007).Conclusions and relevanceThis study found that prehospital tranexamic acid administration was associated with increased mortality in patients with isolated severe TBI, suggesting the judicious use of the drug when no evidence for extracranial hemorrhage is present.
| S-EPMC7953275 | biostudies-literature
Project description:BackgroundNewer research comparing routes of medication administration has extended beyond efficacy as a primary endpoint to incorporate patient preference. However, little is known about the preferences of pregnant women in terms of routes of medication administration, specifically with regards to hemorrhage prevention and control.ObjectiveThis study aimed to understand the preferences of pregnant women in terms of medical interventions to prevent hemorrhage at the time of delivery.Study designSurveys were distributed from April 2022 to September 2022 using electronic tablets at a single urban center with an annual delivery volume of 3000 women per year to women >18 years of age who were either currently pregnant or have been pregnant in the past. Subjects were asked to choose their preferred route of administration from the following options: intravenous, intramuscular, or subcutaneous. The primary outcome was patient preference on the route of medication administration during a hemorrhage event.ResultsThe study cohort included 300 patients, mostly African American (39.8%) followed by White (32.1%), and the majority of the participants ranged from 30 to 34 years of age (31.7%). When asked which method of administration they would prefer to prevent hemorrhage before birth, the results were as follows: 31.1% would prefer intravenous, 23.0% had no preference, 21.2% were unsure, 15.9% preferred subcutaneous, and 8.8% preferred intramuscular administration. In addition, 69.4% of respondents reported that they have never declined or avoided intramuscular administration of medication if recommended by their physician.ConclusionAlthough some survey participants preferred an intravenous route of administration, 68.9% of subjects were unsure, had no preference, or preferred nonintravenous routes. This information is helpful particularly in low-resource settings where intravenous treatments are not readily available or in urgent clinical situations in which intravenous administration routes are not easily obtainable in high-risk patients.
| S-EPMC10173762 | biostudies-literature
Project description:The prevalence of tranexamic acid (TXA) use for trauma and other conditions in children is unknown.The objective of this study was to describe the use of TXA in United States (US) children's hospitals for children in general, and specifically for trauma.We conducted a secondary analysis of a large, administrative database of 36 US children's hospitals. We included children <18 years of age who received TXA (based on pharmacy charge codes) between 2009 and 2013. Patients were grouped into the following diagnostic categories: trauma, congenital heart surgery, scoliosis surgery, craniosynostosis/craniofacial surgery, and other, based on the International Classification of Diseases, Ninth Revision principal procedure and diagnostic codes. TXA administration and dosage, in-hospital clinical variables, and diagnostic and procedure codes were documented.A total of 35,478 pediatric encounters with a TXA charge were included in the study cohort. The proportions of children who received TXA were similar across the years 2009 to 2013. Only 110 encounters (0.31%) were for traumatic conditions. Congenital heart surgery accounted for more than one-half of the encounters (22,863; 64%). Overall, the median estimated weight-based dose of TXA was 22.4 mg/kg (interquartile range, 7.3-84.9 mg/kg).We identified a wide frequency of use and range of doses of TXA for several diagnostic conditions in children. The use of TXA among injured children, however, appears to be rare despite its common use and efficacy among injured adults. Additional work is needed to identify appropriate indications for TXA and provide dosage guidelines among children with a variety of conditions, including trauma.
| S-EPMC4912435 | biostudies-literature
Project description:BackgroundThere is a potential role for tranexamic acid (TXA) use in foot and ankle procedures; however, the benefits of this intervention have not been fully elucidated. The purpose of this study was to explore the safety, outcomes, and medical complication profile of the use of intravenous TXA in patients undergoing foot and ankle surgery.MethodsA prospective study with retrospective review of 241 patients undergoing elective and traumatic foot and ankle procedures was performed. One gram of intravenous (IV) TXA was administered prior to incision. Patients were followed and evaluated for medical comorbidities, intraoperative blood loss, wound complication, superficial and deep infections, hematoma formation, medical complications, 30-day hospital readmission rate, and return visits to the emergency department or urgent care setting prior to first postoperative visit. Descriptive statistics were used for subgroup analysis. Mean postoperative follow-up was 4.5 months.ResultsEstimated blood loss in all cases was less than 20 mL. There was 1 case of superficial cellulitis (1/241, 0.4%), 1 deep infection after Achilles tendon repair (1/241, 0.4%), 4 cases of delayed wound healing (4/241, 1.6%), 1 instance of deep vein thrombosis (1/241, 0.4%), and 2 cases of postoperative pulmonary embolism (2/241, 0.8%). There were no instances of postoperative hematoma formation. There were no additional recorded thromboembolic events. There were no adverse drug reactions. There were no 30-day hospital readmissions or return visits to the emergency department or urgent care setting before the first postoperative visit. In a subgroup analysis, there was no significant difference in wound complications or infections between nondiabetics and diabetics (P > .05) and traumatic and nontraumatic cases (P > .05).ConclusionsThe use of IV TXA in foot and ankle surgeries was associated with low risk of wound complications, infections, hematoma formation, thromboembolic events, and overall complication rates with minimal side effect profile. Perioperative tranexamic acid use may prove to be beneficial in foot and ankle surgery patients but especially in higher-risk patients such as those with diabetes, trauma, and those that are immunocompromised.Level of evidenceLevel IV, case series.
| S-EPMC8564923 | biostudies-literature
Project description:Objective: Intracranial hemorrhage (ICH) is a common complication of traumatic brain, in which tranexamic acid has been recommended as an additional therapy to prevent a second bleeding. However, the effect of early administration of tranexamic acid for ICH patients remains controversial. Methods: A systematic search was performed in Cochrane Library, Medline, Embase, and Web of Science. Poor outcome refers to significant hemorrhage growth, new intracranial hemorrhage, new focal cerebral ischaemic lesions, the need for neurosurgery, or death. Study heterogeneity and publication bias were estimated. Results: Seven randomized controlled trials involving 3,192 participants were included in our meta-analysis. Tranexamic acid administration in ICH patients was associated with better outcomes of hematoma expansion (odd ratios [OR] 0.79; 95% confidence interval (CI) CI, 0.67-0.93; I 2 = 0%; P = 0.006) and growth of hemorrhagic lesions (weighted mean difference [WMD], -1.97 ml; 95% CI, -2.94 to -1.00; I 2 = 14%; P < 0.001) than the placebo. No difference was found between the mortality, poor outcome, neurosurgical intervention, new bleeding, and the duration of hospital stay. Moreover, no publication bias was found. Conclusion: Our analysis reveals that the early treatment with tranexamic acid can significantly reduce the incidence of hematoma expansion and the volume of hemorrhagic lesion, but does not exert considerable effects on mortality, poor outcome, neurosurgery, rebleeding, and the duration of stay.
| S-EPMC8685213 | biostudies-literature
Project description:BackgroundPrehospital tranexamic acid (TXA) may hold substantial benefits for trauma patients; however, the data underlying its efficacy and safety is scarce.MethodsWe searched PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov from inception to July 2023 for all randomized controlled trials (RCTs) investigating prehospital TXA in trauma patients as compared to placebo or standard care without TXA. Data were pooled under a random-effects model using RevMan 5.4 with risk ratio (RR) and mean difference (MD) as the effect measures.ResultsA total of three RCTs were included in this review. Regarding the primary outcomes, prehospital TXA reduced the risk of 1-month mortality (RR 0.82, 95% CI 0.69-0.97) but did not increase survival with a favorable functional outcome at 6 months (RR 1.00, 95% CI 0.93-1.09). Prehospital TXA also reduced the risk of 24-h mortality but did not affect the risk of mortality due to bleeding and traumatic brain injury. There was no significant difference between the TXA and control groups in the incidence of RBC transfusion, and the number of ventilator- and ICU-free days. Prehospital TXA did not increase the risk of adverse events except for a small increase in the incidence of infections.ConclusionPrehospital TXA is useful in reducing mortality in trauma patients without a notable increase in the risk of adverse events. However, there was no effect on the 6-month favorable functional status. Further large-scale trials are required to validate the aforementioned findings.Systematic review registrationPROSPERO (CRD42023451759).
| S-EPMC10623347 | biostudies-literature