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1.
Characterization and Analysis of Chitosan-Gelatin Composite-Based Biomaterial Effectivity as Local Hemostatic Agent: A Systematic Review
Herliana H, Yusuf HY, Laviana A, Wandawa G, Cahyanto A
Polymers. 2023;15(3)
Abstract
Chitosan and gelatin were the most widely used natural materials in pharmaceutical and medical fields, especially as local hemostatic agents, independently or as a composite material with the addition of other active substances. Chitosan and gelatin have excellent properties in biocompatibility, biodegradability, non-toxicity and water absorption capacity. The objective of this review was to analyze the characteristics of chitosan-gelatin (CG) composite-based biomaterial and its effectivity as a local hemostatic agent. We used PRISMA guidelines and the PICO framework to compile this review. The findings demonstrated that the CG composite-based biomaterial had excellent physical, chemical, mechanical properties and local hemostatic agent activity by adding other active substances such as oxidized fibers (OF), silica nanoparticles (SiNPs), calcium (Ca) and biphasic calcium phosphate (BCP) or by setting the CG composite proportion ratio.
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2.
Efficacy of high dose tranexamic acid (TXA) for hemorrhage: A systematic review and meta-analysis
Hmidan Simsam M, Delorme L, Grimm D, Priestap F, Bohnert S, Descoteaux M, Hilsden R, Laverty C, Mickler J, Parry N, et al
Injury. 2023
Abstract
BACKGROUND Standard dose (≤ 1 g) tranexamic acid (TXA) has established mortality benefit in trauma patients. The role of high dose IV TXA (≥2 g or ≥30 mg/kg as a single bolus) has been evaluated in the surgical setting, however, it has not been studied in trauma. We reviewed the available evidence of high dose IV TXA in any setting with the goal of informing its use in the adult trauma population. METHODS We searched MEDLINE, EMBASE and unpublished sources from inception until July 27, 2022 for studies that compared standard dose with high dose IV TXA in adults (≥ 16 years of age) with hemorrhage. Screening and data abstraction was done independently and in duplicate. We pooled trial data using a random effects model and considered randomized controlled trials (RCTs) and observational cohort studies separately. We assessed the individual study risk of bias using the Cochrane Risk of Bias for RCTs and the Newcastle-Ottawa Scale for observational cohort studies. The overall certainty of evidence was assessed using the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation). RESULTS We included 20 studies with a combined total of 12,523 patients. Based on pooled RCT data, and as compared to standard dose TXA, high dose IV TXA probably decreases transfusion requirements (odds ratio [OR] 0.86, 95% confidence interval [CI] 0.76 to 0.97, moderate certainty) but with possibly no effect on blood loss (mean difference [MD] 43.31 ml less, 95% CI 135.53 to 48.90 ml less, low certainty), and an uncertain effect on thromboembolic events (OR 1.33, 95% CI 0.86 to 2.04, very low certainty) and mortality (OR 0.70, 95% CI 0.37 to 1.32, very low certainty). CONCLUSION When compared to standard dose, high dose IV TXA probably reduces transfusion requirements with an uncertain effect on thromboembolic events and mortality. LEVEL OF EVIDENCE Systematic review and meta-analysis, level IV.
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3.
Impact of time and distance on outcomes following tourniquet use in civilian and military settings: A scoping review
Joarder M, Noureddine El Moussaoui H, Das A, Williamson F, Wullschleger M
Injury. 2023
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Editor's Choice
Abstract
BACKGROUND The last two decades have seen the reintroduction of tourniquets into guidelines for the management of acute limb trauma requiring hemorrhage control. Evidence supporting tourniquet application has demonstrated low complication rates in modern military settings involving rapid evacuation timeframes. It is unclear how these findings translate to patients who have prolonged transport times from injury in rural settings. This scoping review investigates the relationship between time and distance on metabolic complications, limb salvage and mortality following tourniquet use in civilian and military settings. METHODS A systematic search strategy was conducted using PubMed, Embase, and SafetyLit databases. Study characteristics, setting, mechanism of injury, prehospital time, tourniquet time, distance, limb salvage, metabolic response, mortality, and tourniquet removal details were extracted from eligible studies. Descriptive statistics were recorded, and studies were grouped by ischemia time (< 2 h, 2-4 h, or > 4 h). RESULTS The search identified 3103 studies, from which 86 studies were included in this scoping review. Of the 86 studies, 55 studies were primarily in civilian environments and 32 were based in military settings. One study included both settings. Blast injury was the most common mechanism of injury sustained by patients in military settings (72.8% [5968/8200]) followed by penetrating injury (23.5% [1926/8200]). In contrast, in civilian settings penetrating injury was the most common mechanism (47.7% [1633/3426]) followed by blunt injury (36.4% [1246/3426]). Tourniquet time was reported in 66/86 studies. Tourniquet time over four hours was associated with reduced limb salvage rates (57.1%) and higher mortality rates (7.1%) compared with a tourniquet time of less than two hours. The overall limb salvage and mortality rates were 69.6% and 6.7% respectively. Metabolic outcomes were reported in 28/86 studies with smaller sample sizes and inconsistencies in which parameters were reported. CONCLUSION This scoping review presents literature describing comparatively safe tourniquet application when used for less than two hours duration. However, there is limited research describing prolonged tourniquet application or when used for protracted distances, such that the impact of tourniquet release time on metabolic outcomes and complications remains unclear. Prospective studies utilizing the development of an international database to provide this dataset is required.
PICO Summary
Population
Patients in civilian and military settings who had a tourniquet applied for the management of acute limb trauma (86 studies).
Intervention
Scoping review investigating the relationship between time and distance on metabolic complications, limb salvage and mortality following tourniquet use.
Comparison
Outcome
Most included studies (55) were based in civilian environments, 32 were based in military settings, and 1 included both settings. Blast injury was the most common mechanism of injury sustained by patients in military settings (72.8% [5968/8200]) followed by penetrating injury (23.5% [1926/8200]). In civilian settings, penetrating injury was the most common mechanism (47.7% [1633/3426]) followed by blunt injury (36.4% [1246/3426]). Tourniquet time was reported in 66/86 studies. Tourniquet time over four hours was associated with reduced limb salvage rates (57.1%) and higher mortality rates (7.1%) compared with a tourniquet time of less than two hours. The overall limb salvage and mortality rates were 69.6% and 6.7% respectively. Metabolic outcomes were reported in 28/86 studies with smaller sample sizes and inconsistencies in which parameters were reported.
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4.
The Efficacy of Tranexamic Acid for the Treatment of Traumatic Hip Fractures: A Network Meta-Analysis
Bloom DA, Lin CC, Manzi JE, Mojica ES, Telgheder ZL, Chapman CB
Journal of orthopaedic trauma. 2023
Abstract
OBJECTIVES Network meta-analysis to compare the efficacy of different dosages of intravenous(IV) acid(TXA) in the treatment of traumatic hip fractures against the control group of no TXA. DATA SOURCES This study utilized the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to perform a network meta-analysis on the use of TXA for the treatment of hip fractures. The study team utilized Ovid MEDLINE, Cochrane Reviews, Scopus, Embase, and Web of Science databases to perform the search. Studies were selected that were published in English between the years 2010 and 2020. STUDY SELECTION/DATA EXTRACTION For inclusion in this study, selected manuscripts were required to be randomized controlled trials with at least one control group had no anti-fibrinolytic intervention to serve as a control, IV formulations of TXA were utilized as part of the treatment group. Furthermore, all study participants must have undergone surgical intervention for traumatic hip fractures. Studies that did not immediately meet criteria for inclusion were saved for review by the full investigating team and were included based on consensus. DATA SYNTHESIS All statistical analyses conducted for this study were performed using R (R Foundation for Statistical Computing, Vienna, Austria). Network meta-analyses were conducted with a frequentist approach with a random effects model using the netmeta package version 0.9-6 in R. The frequentist equivalent to surface under the cumulative ranking (SUCRA) probabilities, termed "P-Score" was used to rank different treatments. CONCLUSION The use of TXA in the surgical management of traumatic hip fractures reduces the number of transfusions and perioperative blood loss, with minimal to no increased incidence of thrombotic events when compared to control. When comparing formulations, no route of administration is clearly superior in reducing perioperative blood loss.
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5.
The risk of thromboembolic events with early intravenous 2- and 4-g bolus dosing of tranexamic acid compared to placebo in patients with severe traumatic bleeding: A secondary analysis of a randomized, double-blind, placebo-controlled, single-center trial
Spinella PC, Bochicchio K, Thomas KA, Staudt A, Shea SM, Pusateri AE, Schuerer D, Levy JH, Cap AP, Bochicchio G
Transfusion. 2022
Abstract
BACKGROUND Screening for the risk of thromboembolism (TE) due to tranexamic acid (TXA) in patients with severe traumatic injury has not been performed in randomized clinical trials. Our objective was to determine if TXA dose was independently-associated with thromboembolism. STUDY DESIGN AND METHODS This is a secondary analysis of a single-center, double-blinded, randomized controlled trial comparing placebo to a 2-g or 4-g intravenous TXA bolus dose in trauma patients with severe injury. We used multivariable discrete-time Cox regression models to identify associations with risk for thromboembolic events within 30 days post-enrollment. Event curves were created using discrete-time Cox regression. RESULTS There were 50 patients in the placebo group, 49 in the 2-g, and 50 in the 4-g TXA group. In adjusted analyses for thromboembolism, a 2-g dose of TXA had an hazard ratio (HR, 95% confidence interval [CI]) of 3.20 (1.12-9.11) (p = .029), and a 4-g dose of TXA had an HR (95% CI) of 5.33 (1.94-14.63) (p = .001). Event curves demonstrated a higher probability of thromboembolism for both doses of TXA compared to placebo. Other parameters independently associated with thromboembolism include time from injury to TXA administration, body mass index, and total blood products transfused. DISCUSSION In patients with severe traumatic injury, there was a dose-dependent increase in the risk of at least one thromboembolic event with TXA. TXA should not be withheld, but thromboembolism screening should be considered for patients receiving a dose of at least 2-g TXA intravenously for traumatic hemorrhage.
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6.
Permissive hypotension compared to fluid therapy for the management of traumatic haemorrhage: a rapid review
Clarke R, Dippenaar E
British paramedic journal. 2022;7(3):34-43
Abstract
BACKGROUND Haemorrhage and subsequent hypovolemia from traumatic injury is a potentially reversible cause of cardiac arrest, as interventions can be made to increase circulatory volume and organ perfusion. Traditionally, intravenous (IV) fluid therapy is recommended for all patients who have experienced a haemorrhagic emergency. There has been some argument, however, that this may not be the most effective treatment as isotonic fluids can dilute coagulation factors and further stimulate bleeding. Permissive hypotension, also known as hypotensive resuscitation within the context of damage control resuscitation, is a method of managing haemorrhagic trauma patients by restricting IV fluid administration to allow for a reduced blood pressure. It is important to evaluate and compare current research literature on the effects of both permissive hypotension and fluid therapy on patients suffering from traumatic haemorrhage. METHODS A rapid review was conducted by systematically searching and identifying literature to narratively compare permissive hypotension and fluid therapy. Searches were carried out across two databases to find relevant primary research containing quantitative data that provide contextual and statistical evidence to achieve the aim of this review. Papers were narratively synthesised to produce key themes for discussion. RESULTS The database searches identified 125 records, 78 from PubMed and 47 from ScienceDirect. Eleven duplicates were removed, and 114 titles screened. Ninety-four records were initially excluded and nine more after abstract review. Eleven papers were critiqued using Benton and Cormack's framework, with eight articles included in the final review. CONCLUSION Permissive hypotension may have a positive impact on 30-day mortality, when compared with fluid resuscitation methods, however there is evidence to suggest that hypotensive resuscitation may be more effective for blunt force injuries. Some studies even suggest a reduction in the treatment cost when reducing fluid volumes. Penetrating injuries are usually more likely to be a compressible source of haemorrhage within which haemorrhage control can be gained much more easily. There are recommendations for the use of permissive hypotension in both compressible and non-compressible injuries. It is difficult at this time to draw definitive conclusions for the treatment of every case related to traumatic haemorrhage given the variability and unpredictability of trauma.
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7.
Simulation-based Education Improves Military Trainees' Skill Performance and Self- Confidence in Tourniquet Placement: A Randomized Controlled Trial
Scalese RJ, Issenberg SB, Hackett M, Rodriguez RD, Brotons AA, Gonzalez M, Geracci JJ, Schulman CI
The journal of trauma and acute care surgery. 2022
Abstract
BACKGROUND Tactical Combat Casualty Care (TCCC) is the standard of care for stabilization and treatment of military trauma patients. The DoD has mandated that all Service members receive role-based TCCC training and certification. Simulation education can increase procedural skills by providing opportunities for deliberate practice in safe, controlled environments. We developed and evaluated the effectiveness of a simulation-based TCCC training intervention to improve participants' skill performance and self-confidence in tourniquet placement. METHODS This study was a single-blinded, randomized trial with waitlist controls. Army ROTC cadets from a single training battalion comprised the study population. After randomization and baseline assessment of all participants, Group A alone received focused, simulation-based TCCC tourniquet application training. Three months later, all participants underwent repeat testing, and after crossover, the waitlist Group B received the same intervention. Two months later, all cadets underwent a third/final assessment. The primary outcome was tourniquet placement proficiency assessed by total score achieved on a standardized 8-item skill checklist. A secondary outcome was self-confidence in tourniquet application skill as judged by participants' Likert scale ratings. RESULTS Forty-three Army ROTC cadets completed the study protocol. Participants in both Group A (n = 25) and Group B (n = 18) demonstrated significantly higher performance from baseline to final assessment at five months and two months, respectively, following the intervention. Mean total checklist score of the entire study cohort increased significantly from 5.53 (SD = 2.00) at baseline to 7.56 (SD = 1.08) at Time 3, a gain of 36.7% (p < 0.001). Both groups rated their self-confidence in tourniquet placement significantly higher following the training. CONCLUSIONS A simulation-based TCCC curriculum resulted in significant, consistent, and sustained improvement in participants' skill proficiency and self-confidence in tourniquet placement. Participants maintained these gains two to five months after initial training. LEVEL OF EVIDENCE Level II - RCT with significant difference and only one negative criterion (<80% follow-up).
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A Systematic Review of Tranexamic Acid-Associated Venous Thromboembolic Events in Combat Casualties and Considerations for Prolonged Field Care
Russo RM, Lozano R, Ruf AC, Ho JW, Strayve D, Zakaluzny SA, Keeney-Bonthrone TP
Military medicine. 2022
Abstract
INTRODUCTION Tranexamic acid (TXA) is a standard component of Tactical Combat Casualty Care. Recent retrospective studies have shown that TXA use is associated with a higher rate of venous thromboembolic (VTE) events in combat-injured patients. We aim to determine if selective administration should be considered in the prolonged field care environment. MATERIALS AND METHODS We performed a systematic review using the 2020 Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. Clinical trials and observational studies of combat casualties published between January 1, 1960, and June 20, 2022, were included. We analyzed survival and VTE outcomes in TXA recipients and non-recipients. We discussed the findings of each paper in the context of current and future combat environments. RESULTS Six articles met criteria for inclusion. Only one study was powered to report mortality data, and it demonstrated a 7-fold increase in survival in severely injured TXA recipients. All studies reported an increased risk of VTE in TXA recipients, which exceeded rates in civilian literature. However, five of the six studies used overlapping data from the same registry and were limited by a high rate of missingness in pertinent variables. No VTE-related deaths were identified. CONCLUSIONS There may be an increased risk of VTE in combat casualties that receive TXA; however, this risk must be considered in the context of improved survival and an absence of VTE-associated deaths. To optimize combat casualty care during prolonged field care, it will be essential to ensure the timely administration of VTE chemoprophylaxis as soon as the risk of significant hemorrhage permits.
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9.
Measuring the Effect of Audio Instructions on the Time and Effectiveness of Tourniquet Application by Laypeople
Dayal S, Portela R, Taylor S, Byquist BR, Piner A, Adams J, March J
Prehospital emergency care. 2022;:1-7
Abstract
Objective: The "Stop the Bleed" campaign was created to educate laypeople about bleeding control and make bleeding control kits available in public locations. Unfortunately, previous research has indicated that up to half of all laypeople cannot effectively apply a tourniquet. The purpose of this study was to determine if laypeople could apply tourniquets more effectively with just-in-time training using combined audio-written instructions versus written-only instructions.Methods: We conducted a prospective randomized study comparing the application of a tourniquet using a simulated bleeding arm. Participants were laypeople 18 years and older and excluded those with any previous tourniquet experience or training. Participants were randomized to just-in-time training using either audio-written or written-only instructions. Time in seconds to tourniquet application and the effectiveness of the tourniquet application was recorded. Effective application was defined as stopping the flow or significantly slowing the flow to a slow drip. Ineffective tourniquet placement was defined as not significantly changing the flow. Statistical analysis was performed using Fisher's exact, t-test, and linear regression.Results: Eighty-two participants were included; 40 were in the audio-written instructions group, and 58.5% were male. The audio-written group's effective application rate was 92.5% and that of the written-only group was 76.2%. A significantly higher rate of ineffective tourniquet application was noted for the written-only group, (23.8%), versus the audio-written group (7.5%), p=.04. Regardless of the type of instructions used, time to effective application of the tourniquet decreased as participant age increased (p = 0.02, 95%CI (-1.24, -0.13). There was no relationship between age and effective tourniquet application (p = 0.06). Time for tourniquet placement was not different between the audio-written (mean 100.4 seconds) and written-only (mean 106.1 seconds) groups (p = 0.58).Conclusion: This study suggests that combined audio-written instructions decrease the rate of ineffective tourniquet application by laypeople compared with written-only instructions. Further studies are needed to assess if audio instructions and just-in-time training can further maximize effective tourniquet application.
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10.
Balanced crystalloid vs saline in adults with traumatic brain injury: secondary analysis of a clinical trial
Lombardo S, Smith MC, Semler MW, Wang L, Dear ML, Lindsell C, Freundlich RE, Guillamondegui OD, Self WH, Rice TW
Journal of neurotrauma. 2022
Abstract
Balanced crystalloids may improve outcomes compared to saline for some critically ill adults. Lower tonicity of balanced crystalloids could worsen cerebral edema in patients with intracranial pathology. The effect of balanced crystalloids versus saline on clinical outcomes in patients with traumatic brain injury (TBI) requires further study. We planned an a priori subgroup analysis of TBI patients enrolled in the pragmatic, cluster-randomized, multiple-crossover Isotonic Solutions and Major Adverse Renal Events Trial (SMART) (ClinicalTrials.gov: NCT02444988, NCT02547779). Primary outcome was 30-day in-hospital mortality. Secondary outcomes included hospital discharge disposition (home, facility, death). Regression models adjusted for pre-specified baseline covariates compared outcomes. TBI patients assigned to balanced crystalloids (n=588) and saline (n=569) had similar baseline characteristics including Injury Severity Score 19 (10); mean maximum head/neck Abbreviated Injury Score, 3.4 (1.0). Isotonic crystalloid volume administered between ICU admission and first of hospital discharge or 30 days was 2037 (3470) mL and 1723 (2923) mL in the balanced crystalloids and saline groups, respectively (P=0.18). During the study period, 94 (16%) and 82 (14%) patients (16%) died in the balanced crystalloid and saline groups, respectively (aOR, 1.03; 95% confidence interval [CI], 0.60 to 1.75; P=0.913). Patients in the balanced crystalloid group were more likely to die or be discharged to another medical facility (aOR 1.38 [1.02-1.86]; P=0.04). Overall, balanced crystalloids were associated with worse discharge disposition in critically injured patients with TBI compared to saline. The confidence intervals cannot exclude a clinically relevant increase in mortality when balanced crystalloids are used for patients with TBI.
