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Effectiveness and safety of tranexamic acid in pediatric trauma: A systematic review and meta-analysis
Kornelsen, E., Kuppermann, N., Nishijima, D. K., Ren, L. Y., Rumantir, M., Gill, P. J., Finkelstein, Y.
The American Journal of Emergency Medicine. 2022;55:103-110
Abstract
OBJECTIVE Trauma is the leading cause of childhood death in the United States. Our goal was to determine the effectiveness of tranexamic acid (TXA) in improving survival in pediatric trauma. METHODS MEDLINE (OVID), Embase (OVID), Cochrane Central Register databases, CINAHL (EBSCO), Web of Science (Clarivate Analytics), and grey literature sources were searched for publications reporting survival and safety outcomes in children receiving TXA in acute trauma, with no language restrictions, published until February 11, 2021. Two independent researchers assessed studies for eligibility, bias, and quality. Data on the study setting, injury type, participants, design, interventions, TXA dosing and outcomes were extracted. The primary outcome was survival in children who received TXA following trauma. Forest plots of effect estimates were constructed for each study. Heterogeneity was assessed and data were pooled by meta-analysis using a random-effects model. RESULTS Fourteen articles met inclusion criteria - six single-institution and eight multicentre retrospective cohort studies. Overall, TXA use was not associated with increased survival in pediatric trauma (adjusted odds ratio [aOR]: 0.61, 95% CI: 0.30-1.22) after adjustment for patient-level variables, such as injury severity. Increased survival was documented in the subset of children experiencing trauma in combat settings (aOR for mortality: 0.31, 95% CI: 0.14-0.68). There were no differences in the odds of thromboembolic events (OR 1.15, 95% CI: 0.46-2.87) in children who received TXA versus not. CONCLUSIONS The utility of TXA in children with trauma is unclear. Guidelines supporting TXA use in pediatric trauma may not be based on the available evidence of its use in this context. Rigorous trials measuring survival and other meaningful outcomes and exploring optimal TXA dosing are urgently needed. Study Registration (PROSPERO): CRD42020157683.
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Metrics of shock in pediatric trauma patients: A systematic search and review
Alberto, E. C., McKenna, E., Amberson, M. J., Tashiro, J., Donnelly, K., Thenappan, A. A., Tempel, P. E., Ranganna, A. S., Keller, S., Marsic, I., et al
Injury. 2021;52(10):3166-3172
Abstract
INTRODUCTION Shock-index (SI) and systolic blood pressure (SBP) are metrics for identifying children and adults with hemodynamic instability following injury. The purpose of this systematic review was to assess the quality of these metrics as predictors of outcomes following pediatric injury. MATERIALS AND METHODS We conducted a literature search in Pubmed, SCOPUS, and CINAHL to identify studies describing the association between shock metrics on the morbidity and mortality of injured children and adolescents. We used the data presented in the studies to calculate the sensitivity and specificity for each metric. This study was registered with Prospero, protocol CRD42020162971. RESULTS Fifteen articles met the inclusion criteria. seven studies evaluated SI or SIPA score, an age-corrected version of SI, as predictors of outcomes following pediatric trauma, with one study comparing SIPA score and SBP and one study comparing SI and SBP. The remaining eight studies evaluated SBP as the primary indicator of shock. The median sensitivity for predicting mortality and need for blood transfusion was highest for SI, followed by SIPA, and then SBP. The median specificity for predicting these outcomes was highest for SBP, followed by SIPA, and then SI. CONCLUSIONS Common conclusions were that high SIPA scores were more specific than SI and more sensitive than SBP. SIPA score had better discrimination for severely injured children compared to SI and SBP. An elevated SIPA was associated with a greater need for blood transfusion and higher in-hospital mortality. SIPA is specific enough to exclude most patients who do not require a blood transfusion.
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Appropriate Tourniquet Types in the Pediatric Population: A Systematic Review
Charlton NP, Goolsby CA, Zideman DA, Maconochie IK, Morley PT, Singletary EM
Cureus. 2021;13(4):e14474
Abstract
Trauma is the leading cause of mortality in those aged 1-19, with hemorrhage accounting for up to 40% of all trauma deaths. Manufactured tourniquets are recommended for the control of life-threatening extremity hemorrhage in adults but their use in the pediatric population requires further investigation. We performed a systematic review to evaluate the most appropriate tourniquet design for use in the pediatric population. A literature search of Embase and the Cochran databases of trials and systematic reviews on October 1, 2020 identified 454 unique references, of which 15 were included for full-text screening. Two single-arm observational studies with a high risk of bias evaluated the use of windlass tourniquets in the pediatric population (73 patients, age 2-16 years). The certainty of the evidence was very low. In both studies, conducted on uninjured extremities, the use of a manufactured windlass tourniquet, specifically the Combat Application Tourniquet (C-A-T®) Generation 7, led to the cessation of Doppler detected pulses in 71/71 (100%) of upper extremities and 69/73 (94.5%) of lower extremities. Of the four failures, one participant withdrew due to pain and three tourniquet applications failed to occlude pulses after three turns of the windlass. No controls were used for comparison. In conclusion, two observational studies demonstrated that windlass tourniquets were able to abolish distal pulses in children as young as two years of age and with a minimum limb circumference of 13 cm. These preliminary findings may be helpful for organizations in the creation of guidelines for the management of life-threatening extremity bleeding in children.
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Outcome measures used in clinical research evaluating pre-hospital blood component transfusion in traumatically injured bleeding patients: A systematic review
Tucker H, Avery P, Brohi K, Davenport R, Griggs J, Weaver A, Green L
The journal of trauma and acute care surgery. 2021
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Editor's Choice
Abstract
BACKGROUND Trial outcomes should be relevant to all stakeholders, and allow assessment of interventions' efficacy and safety at appropriate timeframes. There is no consensus regarding outcome measures in the growing field of pre-hospital trauma transfusion research. Harmonization of future clinical outcome reporting is key to facilitate inter-study comparisons and generate cohesive, robust evidence to guide practice. OBJECTIVES To evaluate outcome measures reported in pre-hospital trauma transfusion trials. METHODS Data Sources, Eligibility Criteria, Participants and InterventionsWe conducted a scoping systematic review to identify the type, number and definitions of outcomes reported in randomised controlled trials, prospective and retrospective observational cohort studies investigating pre-hospital blood component transfusion in adult and paediatric patients with traumatic haemorrhage. Electronic database searching of PubMed, Embase, Web of Science, Cochrane, OVID, clinical trials.gov, and the Transfusion Evidence Library was completed in accordance with PRISMA guidelines.Study Appraisal and Synthesis MethodsTwo review authors independently extracted outcome data. Unique lists of salutogenic (patient-reported health and wellbeing outcomes) and non-salutogenic focused outcomes were established. RESULTS 3,471 records were identified. 34 studies fulfilled inclusion criteria: four military (n = 1,566 patients) and 30 civilian (n = 14,398 patients), all between 2000 and 2020. 212 individual non-patient-reported outcomes were identified, which collapsed into 20 outcome domains with varied definitions and timings. All primary outcomes measured effectiveness, rather than safety or complications. 69% reported mortality, with 11 different definitions. No salutogenic outcomes were reported. LIMITATIONS The review is limited by a lack of high-grade prospective comparative trials with clear predefined primary outcomes. CONCLUSION AND IMPLICATIONS OF KEY FINDINGS There is heterogeneity in outcome reporting and definitions, an absence of patient-reported outcome, and an emphasis on clinical effectiveness rather than safety or adverse events in pre-hospital trauma transfusion trials. We recommend stakeholder consultation and a Delphi process to develop a clearly defined minimum core outcome set for pre-hospital trauma transfusion trials. SYSTEMATIC REVIEW REGISTRATION NUMBER This review was prospectively registered with PROSPERO (CRD42019131406). LEVEL OF EVIDENCE II. STUDY TYPE Scoping Systematic Review.
PICO Summary
Population
Adult and paediatric patients with traumatic haemorrhage (34 studies, n= 15,964).
Intervention
Systematic review to identify the type, number and definitions of outcomes reported in pre-hospital trauma transfusion research.
Comparison
Outcome
212 individual non-patient-reported outcomes were identified, which collapsed into 20 outcome domains with varied definitions and timings. All primary outcomes measured effectiveness, rather than safety or complications. 69% reported mortality, with 11 different definitions. No salutogenic outcomes were reported.
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Accuracy of risk tools to predict critical bleeding in major trauma: a systematic review with meta-analysis
Gianola S, Castellini G, Biffi A, Porcu G, Napoletano A, Coclite D, D'Angelo D, Fauci AJ, Iacorossi L, Latina R, et al
The journal of trauma and acute care surgery. 2021
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Editor's Choice
Abstract
BACKGROUND Early detection of critical bleeding by accurate tools can help ensure rapid delivery of blood products to improve outcomes in major trauma patients. We conducted a systematic review to evaluate the accuracy of risk tools to predict critical bleeding in patients with major trauma. METHODS PubMed, Embase and CENTRAL were searched up to February 2021 for studies investigating risk tools to predict critical bleeding for major trauma people in pre-hospital and emergency department. We followed the PRISMA-DTA guidelines. Two independent authors included studies, extracted data, appraised the quality using the Quality Assessment of Diagnostic Accuracy Studies-2 and assessed the certainty of evidence using thee Grading of Recommendations Assessment, Development and Evaluation methodology. Sensitivity, specificity and the Receiver Operating Characteristics curve for all selected triage tools. RESULTS Eighty-nine observational studies for adults and 12 observational studies for children met our inclusion criteria. In adults, we found 23 externally validated and 28 un-validated tools; in children, 3 externally validated tools and 5 un-validated. In the externally validated tools, we identified those including clinical, laboratory and ultrasound assessments. Among tools including only a clinical assessment, the Shock Index showed high sensitivity and specificity with the Certainty of Evidence ranging from very low to moderate in adults, as well as Shock Index Pediatric Age-adjusted (SIPA) with a moderate Certainty of Evidence. We found that tools using clinical, laboratory and ultrasound assessments were overall more accurate than those tools without all three components. CONCLUSIONS Clinicians should consider risk tools to predict critical bleeding in a time-sensitive setting like major life threatening trauma. The Shock index and SIPA are easy and handy tools to predict critical bleeding in the pre-hospital setting. In the emergency department, however, many other tools can be utilized which include laboratory and ultrasound assessments, depending on staff experience and resources. LEVEL OF EVIDENCE Systematic review, diagnostic Level III.
PICO Summary
Population
Adults and children with major trauma (101 studies).
Intervention
Systematic review to identify the most accurate risk tools to predict critical bleeding.
Comparison
Outcome
Twenty-three externally validated and 28 un-validated tools were found for adults, and 3 externally validated tools and 5 un-validated, for children. Among tools including only a clinical assessment, the Shock Index showed high sensitivity and specificity with the Certainty of Evidence ranging from very low to moderate in adults, as well as Shock Index Paediatric Age-adjusted with a moderate Certainty of Evidence. It was found that tools using clinical, laboratory and ultrasound assessments were overall more accurate than those tools without all three components.
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Massive Transfusion Protocols in Pediatric Trauma Population: A Systematic Review
Kinslow K, McKenney M, Boneva D, Elkbuli A
Transfus Med. 2020
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Editor's Choice
Abstract
BACKGROUND Our main objective was to review the literature to answer the following questions regarding pediatric massive transfusion (PMT) protocols: 1) How is PMT defined? 2) Which blood product ratios have been investigated and what is their effect on outcomes? 3) What evidence exists regarding PMT outcomes? METHODS The PRISMA guidelines were used. We searched PubMed, Google Scholar, Cochrane Library, EMBASE, Wiley Online Library, and Ovid. Articles were screened for inclusion based on relevance to PMT. Articles were assessed for study design, presence of established/tested PMT, PMT definition, PMT activation criteria, and Transfusion Ratios, for final determination of article inclusion. RESULTS Our search produced 3213 articles with 33 included for final review. Existing definitions of PMT are based on volume administered/kg but vary in timeframe criteria (over 4 hr vs 24 hr). Some studies have investigated "high" balanced transfusion ratios as seen in adults (1:1 FFP:pRBC) with a few showing statistically significant improvement in pediatric mortality vs lower ratios. PMT protocol implementation has not been shown to consistently reduce pediatric trauma mortality across multiple centers. However, other operational aspects such as reduced time to first transfusion are apparent benefits. CONCLUSIONS There is poor consensus over the definition of PMT. Definitions that involve early recognition have the most promise for practice and future studies. Evidence supporting an optimal blood product ratio in PMT is also lacking but trends towards supporting balanced approaches. Implementation of PMT protocols have been limited in showing significant improvement of overall pediatric trauma mortality but may reduce associated morbidity.
PICO Summary
Population
Paediatric trauma patients undergoing massive transfusions (33 studies).
Intervention
Systematic review to define paediatric massive transfusion (PMT) protocols, and to review the evidence on PMT outcomes.
Comparison
Outcome
Existing definitions of PMT are based on volume administered/kg but vary in timeframe criteria (over 4 hr vs. 24 hr). Some studies have investigated "high" balanced transfusion ratios as seen in adults (1:1 FFP:pRBC) with a few showing statistically significant improvement in paediatric mortality vs. lower ratios. PMT protocol implementation has not been shown to consistently reduce paediatric trauma mortality across multiple centers. However, other operational aspects such as reduced time to first transfusion are apparent benefits.
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Pediatric blunt renal trauma practice management guidelines: Collaboration between the Eastern Association for the Surgery of Trauma and the Pediatric Trauma Society
Hagedorn JC, Fox N, Ellison JS, Russell R, Witt CE, Zeller K, Ferrada P, Draus JM Jr
The Journal of Trauma and Acute Care Surgery. 2019;86(5):916-925
Abstract
BACKGROUND Injury to the kidney from either blunt or penetrating trauma is the most common urinary tract injury. Children are at higher risk of renal injury from blunt trauma than adults, but no pediatric renal trauma guidelines have been established. The authors reviewed the literature to guide clinicians in the appropriate methods of management of pediatric renal trauma. METHODS Grading of Recommendations Assessment, Development and Evaluation methodology was used to aid with the development of these evidence-based practice management guidelines. A systematic review of the literature including citations published between 1990 and 2016 was performed. Fifty-one articles were used to inform the statements presented in the guidelines. When possible, a meta-analysis with forest plots was created, and the evidence was graded. RESULTS When comparing nonoperative management versus operative management in hemodynamically stable pediatric patient with blunt renal trauma, evidence suggests that there is a reduced rate of renal loss and blood transfusion in patients managed nonoperatively. We found that in pediatric patients with high-grade American Association for the Surgery of Trauma grade III-V (AAST III-V) renal injuries and ongoing bleeding or delayed bleeding, angioembolization has a decreased rate of renal loss compared with surgical intervention. We found the rate of posttraumatic renal hypertension to be 4.2%. CONCLUSION Based on the completed meta-analyses and Grading of Recommendations Assessment, Development and Evaluation profile, we are making the following recommendations: (1) In pediatric patients with blunt renal trauma of all grades, we strongly recommend nonoperative management versus operative management in hemodynamically stable patients. (2) In hemodynamically stable pediatric patients with high-grade (AAST grade III-V) renal injuries, we strongly recommend angioembolization versus surgical intervention for ongoing or delayed bleeding. (3) In pediatric patients with renal trauma, we strongly recommend routine blood pressure checks to diagnose hypertension. This review of the literature reveals limitations and the need for additional research on diagnosis and management of pediatric renal trauma. LEVEL OF EVIDENCE Guidelines study, level III.