Appropriate Tourniquet Types in the Pediatric Population: A Systematic Review
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.
Enrollment with and without Exception from Informed Consent in a Pilot Trial of Tranexamic Acid in Children with Hemorrhagic Injuries
Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2021
BACKGROUND Federal exception from informed consent (EFIC) procedures allow studies to enroll patients with time-sensitive, life-threatening conditions when written consent is not feasible. Our objective was to compare enrollment rates with and without EFIC in a trial of tranexamic acid (TXA) for children with hemorrhagic injuries. METHODS We conducted a four-center randomized controlled pilot and feasibility trial evaluating TXA in children with severe hemorrhagic brain and/or torso injuries. We initiated the trial enrolling patients without EFIC. After 3 months of enrollment, we met our a priori futility threshold and paused the trial to incorporate EFIC procedures and obtain regulatory approval. We then restarted the trial allowing EFIC if the guardian was unable to provide timely written consent. We used descriptive statistics to compare characteristics of eligible patients approached with and without EFIC procedures. We also calculated the time delay to restart the trial using EFIC. RESULTS We enrolled 1 of 15 (6.7%) eligible patients (0.17 per site per month) prior to using EFIC procedures. Of the 14 missed eligible patients, 7 (50%) were not enrolled because guardians were not present or were injured and unable to provide written consent. After obtaining approval for EFIC, we enrolled 30 of 48 (62.5%) eligible patients (1.34 per site per month). Of these 30 patients, 22 (73.3%) were enrolled with EFIC. Of the 22, no guardians refused written consent after randomization. There were no significant differences in the eligibility rate and patient characteristics enrolled with and without EFIC procedures. Across all sites, the mean delay to restart the trial using EFIC procedures was 12 months. CONCLUSIONS In a multicenter trial of severely injured children, the use of EFIC procedures greatly increased the enrollment rate and was well accepted by guardians. Initiating the trial without EFIC procedures led to a significant delay in enrollment.
Outcome measures used in clinical research evaluating pre-hospital blood component transfusion in traumatically injured bleeding patients: A systematic review
The journal of trauma and acute care surgery. 2021
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.
Adult and paediatric patients with traumatic haemorrhage (34 studies, n= 15,964).
Systematic review to identify the type, number and definitions of outcomes reported in pre-hospital trauma transfusion research.
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.
Massive Transfusion Protocols in Pediatric Trauma Population: A Systematic Review
Transfus Med. 2020
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.
Paediatric trauma patients undergoing massive transfusions (33 studies).
Systematic review to define paediatric massive transfusion (PMT) protocols, and to review the evidence on PMT outcomes.
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.
TXA Administration in the Field Does Not Affect Admission TEG after Traumatic Brain Injury
The journal of trauma and acute care surgery. 2020
BACKGROUND No FDA-approved medication improves outcomes following traumatic brain injury (TBI). A forthcoming clinical trial that evaluated the effects of two prehospital tranexamic acid (TXA) dosing strategies compared with placebo demonstrated no differences in thromboelastography (TEG) values. We proposed to explore the impact of TXA on markers of coagulation and fibrinolysis in patients with moderate to severe TBI. METHODS Data were extracted from a placebo-controlled clinical trial in which patients ≥15 years old with TBI (Glascow Coma Scale 3-12) and systolic blood pressure ≥90 mmHg were randomized prehospital to receive placebo bolus/placebo infusion (Placebo), 1 gram (g) TXA bolus/1g TXA infusion (Bolus Maintenance [BM]); or 2g TXA bolus/placebo infusion (Bolus Only [BO]). TEG was performed and coagulation measures including prothrombin time (PT), activated partial thromboplastin time (aPTT), international ratio (INR), fibrinogen, D-dimer, plasmin anti-plasmin (PAP), thrombin anti-thrombin (TAT), tissue plasminogen activator (tPA), and plasminogen activator inhibitor-1 (PAI-1) were quantified at admission and six hours later. RESULTS Of 966 patients receiving study drug, 700 had labs drawn at admission and six hours later. There were no statistically significant differences in TEG values, including LY30, between groups (p>0.05). No differences between PT, aPTT, INR, fibrinogen, TAT, tPA, and PAI-1 were demonstrated across treatment groups. Concentrations of D-dimer in TXA treatment groups were less than placebo at six hours (p<0.001). Concentrations of PAP were less in TXA treatment groups than placebo on admission (p<0.001) and six hours (p=0.02). No differences in D-dimer and PAP were observed between BM and BO. CONCLUSION While D-dimer and PAP levels reflect a lower degree of fibrinolysis following prehospital administration of TXA when compared to placebo in a large prehospital trial of patients with TBI, TEG obtained on admission and six hours later did not demonstrate any differences in fibrinolysis between the two TXA dosing regimens and placebo. LEVEL OF EVIDENCE III; Diagnostic.
Tourniquet application by schoolchildren- a randomized crossover study of three commercially available models
The journal of trauma and acute care surgery. 2020;Publish Ahead of Print
BACKGROUND Life threatening hemorrhage is a major cause of preventable mortality in trauma. Studies have demonstrated the effectiveness and safety of commercial tourniquets when used by adult civilians. However, there is no data about tourniquet application by children.This study's goal is to determine which of three commercially available tourniquets is most effective when used by children. METHODS A randomized crossover study was conducted in four elementary schools in Montreal to compare three commercially available tourniquets. The study population is primary school children aged 10-12 years (5th -6th grade). 181 students were invited to participate; 96 obtained parental approval and were recruited.Participants underwent a short 7-minute video training on the use of three commercial tourniquets and were subsequently given a 2-minute practice period. Students were evaluated on their ability to successfully apply the tourniquet and the time to complete application. After applying all three tourniquets, students selected their favorite model.The primary outcome is the proportion of successful applications per tourniquet model. Secondary outcomes include time to successful application for each tourniquet model and tourniquet model preference. RESULTS The Mechanical Advantage Tourniquet (MAT) outperformed the Combat Application Tourniquet (CAT) and the Stretch Wrap and Tuck Tourniquet (SWATT) in terms of success rate (MAT: 67%; CAT: 44%; SWATT 24%; p<0.0001), time to application (MAT: 57 sec; CAT: 80 sec; SWATT 90 sec; p<0.0001) and preference (MAT: 64%; CAT: 30%; SWATT 6%; p<0.0001). CONCLUSION In this study, the MAT performs better in terms of success rate, time to application and preference when used by school aged children. This study can be helpful when facilities are purchasing tourniquets for use by students. LEVEL OF EVIDENCE Level 2Study typerandomized crossover study.
Pediatric blunt renal trauma practice management guidelines: Collaboration between the Eastern Association for the Surgery of Trauma and the Pediatric Trauma Society
The Journal of Trauma and Acute Care Surgery. 2019;86(5):916-925
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.
Damage control resuscitation in pediatric severe trauma
Revista Chilena De Pediatria. 2018;89((1)):118-127.
INTRODUCTION Trauma is an important cause of morbidity and mortality in the pediatric population. It has the first place in mortality in our country without considering perinatal pathologies and congenital malformations. An important percentage of early and late deaths secondary to this cau se, as well as its sequelae, could be prevented with optimal and timely resuscitation. OBJECTIVE To review the applicability of damage control resuscitation (DCR) in severe pediatric trauma, with emphasis on medical management. MATERIAL AND METHODS The PubMed, the Cochrane Library and the Google academic database were used. Search terms (MeSH) were: trauma, polytrauma, resuscitation, damage-control, fluids, permissive hypotension, coagulopathy, massive transfusion and children. RESULTS The concept of DCR can be applied to severe pediatric trauma, taking into account their anatomical and physiological characteristics. The principle is based on the management of the lethal triad (coagulopathy, acidosis and hypothermia) associated with damage control surgery. Limitation of crystalloids, permissive hypotension and hemostatic resuscitation are reviewed in the initial treatment of severe pediatric trauma. CONCLUSION Future studies should establish the true role of permissive hypotension, the optimal relationship between blood products and the best strategy to predict the activation of massive transfusion protocols and their impact on children with severe trauma.
Traumatic hyphema in children. Treatment with epsilon-aminocaproic acid
Forty-nine patients, ages 3 to 18 years, who sustained nonpenetrating unilateral trauma with hyphemas were assigned randomly to receive either 100 mg/kg of epsilon-aminocaproic acid (EACA), an antifibrinolytic agent, orally every 4 hours for 5 days (maximum 30 g/day) or a placebo. No patients ingested acetylsalicylic acid (ASA)-containing compounds before or during admission. Two patients of 24 treated with EACA and 1 of 25 given placebo had rebleeds. The hyphemas in the EACA-treated group took significantly longer to clear (mean, 5.3 versus 2.6 days; P less than 0.001). Because of the low incidence of rebleeds in the placebo group, the efficacy of EACA in reducing the rate of rebleeds could not be determined. Further studies with this drug, controlling for age, race, sickle trait, and pre-admission antiplatelet agents should be undertaken before its routine use in traumatic hyphema management can be recommended.