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1.
Life (Basel) ; 14(5)2024 May 10.
Artículo en Inglés | MEDLINE | ID: mdl-38792640

RESUMEN

Uncontrollable bleeding is recognized as the leading cause of preventable death among trauma patients. Early transfusion of blood products, especially plasma replacing crystalloid and colloid solutions, has been shown to increase survival of severely injured patients. However, the requirements for cold storage and thawing processes prior to transfusion present significant logistical challenges in prehospital and remote areas, resulting in a considerable delay in receiving thawed or liquid plasma, even in hospitals. In contrast, freeze- or spray-dried plasma, which can be massively produced, stockpiled, and stored at room temperature, is easily carried and can be reconstituted for transfusion in minutes, provides a promising alternative. Drawn from history, this paper provides a review of different forms of dried plasma with a focus on in vitro characterization of hemostatic properties, to assess the effects of the drying process, storage conditions in dry form and after reconstitution, their distinct safety and/or efficacy profiles currently in different phases of development, and to discuss the current expectations of these products in the context of recent preclinical and clinical trials. Future research directions are presented as well.

2.
Life (Basel) ; 14(2)2024 Jan 24.
Artículo en Inglés | MEDLINE | ID: mdl-38398681

RESUMEN

Despite the importance of the hemostatic properties of reconstituted freeze-dried plasma (FDP) for trauma resuscitation, few studies have been conducted to determine its post-reconstitution hemostatic stability. This study aimed to assess the short- (≤24 h) and long-term (≥168 h) hemostatic stabilities of Canadian and German freeze-dried plasma (CFDP and LyoPlas) after reconstitution and storage under different conditions. Post-reconstitution hemostatic profiles were determined using rotational thromboelastometry (ROTEM) and a Stago analyzer, as both are widely used as standard methods for assessing the quality of plasma. When compared to the initial reconstituted CFDP, there were no changes in ROTEM measurements for INTEM maximum clot firmness (MCF), EXTEM clotting time (CT) and MCF, and Stago measurements for prothrombin time (PT), partial thromboplastin time (PTT), D-dimer concentration, plasminogen, and protein C activities after storage at 4 °C for 24 h and room temperature (RT) (22-25 °C) for 4 h. However, an increase in INTEM CT and decreases in fibrinogen concentration, factors V and VIII, and protein S activities were observed after storage at 4 °C for 24 h, while an increase in factor V and decreases in antithrombin and protein S activities were seen after storage at RT for 4 h. Evaluation of the long-term stability of reconstituted LyoPlas showed decreased stability in both global and specific hemostatic profiles with increasing storage temperatures, particularly at 35 °C, where progressive changes in CT and MCF, PT, PTT, fibrinogen concentration, factor V, antithrombin, protein C, and protein S activities were seen even after storage for 4 h. We confirmed the short-term stability of CFDP in global hemostatic properties after reconstitution and storage at RT, consistent with the shelf life of reconstituted LyoPlas. The long-term stability analyses suggest that the post-reconstitution hemostatic stability of FDP products would decrease over time with increasing storage temperature, with a significant loss of hemostatic functions at 35 °C compared to 22 °C or below. Therefore, the shelf life of reconstituted FDP should be recommended according to the storage temperature.

3.
CJEM ; 25(12): 959-967, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37853308

RESUMEN

OBJECTIVES: Trauma Team Leaders (TTLs) are critical for coordinating and leading trauma resuscitations. This survey sought to characterize the demographics and professional practices of Canadian TTLs at level one trauma centres. As a secondary objective, this information will be utilized to inform the operational goals of the Trauma Association of Canada (TAC) TTL Committee. METHODS: A detailed survey, developed by the TAC board of directors and TTL committee leads, was sent to 225 TTLs across Canada's level one trauma centres. TTLs were identified via contacting trauma directors at each level one centre, in addition to public registry searches. This survey captured demographics, professional background, resuscitation practices, trauma team composition, and TTL involvement in trauma responses. RESULTS: The response rate was 41.7%. Mean respondent age was 42 (SD 7.4) and 71.0% were male. Most TTLs trained in emergency medicine (53.1%) or general surgery (25.5%); 63.8% underwent TTL training: either via a trauma surgery fellowship or TTL fellowship. All centres have a massive hemorrhage protocol implemented, and there is no large variation between the rates of use of cryoprecipitate and fibrinogen, nor the ratio of blood products transfused (2:1 vs 1:1). Most TTL respondents intend to participate in a TTL group associated with TAC (85.1%). CONCLUSION: The results of this survey will contribute to the recognition of TTLs as a crucial role in the initial phase of care of severely injured trauma patients and serves as the first publication to document professional backgrounds and practices of Canadian TTLs at level one trauma centres. All the information gathered via this survey will be used by the TAC TTL Committee, which will focus on several initiatives such as the dissemination of best practice guidelines and creation of a TTL stream at the TAC Annual Conference.


RéSUMé: OBJECTIFS: Les chefs d'équipe de traumatologie (TTL) sont essentiels pour coordonner et diriger les réanimations traumatiques. Cette enquête visait à caractériser la démographie et les pratiques professionnelles des TTL canadiens dans les centres de traumatologie de niveau 1. À titre d'objectif secondaire, cette information sera utilisée pour éclairer les objectifs opérationnels du Comité TTL de l'Association canadienne de traumatologie (ATC). MéTHODES: Un sondage détaillé, élaboré par le conseil d'administration de l'ATC et les responsables des comités de TTL, a été envoyé à 225 TTL dans les centres de traumatologie de niveau 1 du Canada. Les TTL ont été identifiés en contactant les directeurs de traumatologie de chaque centre de niveau 1, en plus des recherches dans le registre public. Cette enquête a porté sur la démographie, les antécédents professionnels, les pratiques de réanimation, la composition de l'équipe de traumatologie et la participation de la TTL aux réponses traumatologiques. RéSULTATS: Le taux de réponse était de 41,7 %. L'âge moyen des répondants était de 42 ans (ET 7,4) et 71,0 % étaient des hommes. La plupart des TTL ont suivi une formation en médecine d'urgence (53,1%) ou en chirurgie générale (25,5%); 63,8% ont suivi une formation TTL : soit via une bourse en chirurgie traumatologique ou une bourse TTL. Tous les centres ont mis en œuvre un protocole d'hémorragie massive, et il n'y a pas de grande variation entre les taux d'utilisation du cryoprécipité et du fibrinogène, ni entre le rapport des produits sanguins transfusés (2:1 vs 1:1). La plupart des répondants TTL ont l'intention de participer à un groupe TTL associé au TAC ( 85,1 %). CONCLUSION: Les résultats de ce sondage contribueront à la reconnaissance des TTL comme un rôle crucial dans la phase initiale des soins aux patients ayant subi un traumatisme grave et serviront de première publication pour documenter les antécédents et les pratiques professionnelles des TTL canadiens au niveau un centres de traumatologie. Toutes les informations recueillies dans le cadre de cette enquête seront utilisées par le Comité TAC TTL, qui se concentrera sur plusieurs initiatives telles que la diffusion de lignes directrices sur les meilleures pratiques et la création d'un flux TTL à la conférence annuelle TAC.


Asunto(s)
Medicina de Emergencia , Centros Traumatológicos , Adulto , Humanos , Masculino , Niño , Femenino , Canadá , Encuestas y Cuestionarios
4.
J Trauma Acute Care Surg ; 95(1): 87-93, 2023 07 01.
Artículo en Inglés | MEDLINE | ID: mdl-37012624

RESUMEN

BACKGROUND: Vascular access in hypotensive trauma patients is challenging. Little evidence exists on the time required and success rates of vascular access types. We hypothesized that intraosseous (IO) access would be faster and more successful than peripheral intravenous (PIV) and central venous catheter (CVC) access in hypotensive patients. METHODS: An EAST prospective multicenter trial was performed; 19 centers provided data. Trauma video review was used to evaluate the resuscitations of hypotensive (systolic blood pressure ≤90 mm Hg) trauma patients. Highly granular data from video recordings were abstracted. Data collected included vascular access attempt type, location, success rate, and procedural time. Demographic and injury-specific variables were obtained from the medical record. Success rates, procedural durations, and time to resuscitation were compared among access strategies (IO vs. PIV vs. CVC). RESULTS: There were 1,410 access attempts that occurred in 581 patients with a median age of 40 years (27-59 years) and an Injury Severity Score of 22 [10-34]. Nine hundred thirty-two PIV, 204 IO, and 249 CVC were attempted. Seventy percent of access attempts were successful but were significantly less likely to be successful in females (64% vs. 71%, p = 0.01). Median time to any access was 5.0 minutes (3.2-8.0 minutes). Intraosseous had higher success rates than PIV or CVC (93% vs. 67% vs. 59%, p < 0.001) and remained higher after subsequent failures (second attempt, 85% vs. 59% vs. 69%, p = 0.08; third attempt, 100% vs. 33% vs. 67%, p = 0.002). Duration varied by access type (IO, 36 [23-60] seconds; PIV, 44 [31-61] seconds; CVC 171 [105-298]seconds) and was significantly different between IO versus CVC ( p < 0.001) and PIV versus CVC ( p < 0.001) but not PIV versus IO. Time to resuscitation initiation was shorter in patients whose initial access attempt was IO, 5.8 minutes versus 6.7 minutes ( p = 0.015). This was more pronounced in patients arriving to the hospital with no established access (5.7 minutes vs. 7.5 minutes, p = 0.001). CONCLUSION: Intraosseous is as fast as PIV and more likely to be successful compared with other access strategies in hypotensive trauma patients. Patients whose initial access attempt was IO were resuscitated more expeditiously. Intraosseous access should be considered a first line therapy in hypotensive trauma patients. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.


Asunto(s)
Catéteres Venosos Centrales , Servicios Médicos de Urgencia , Femenino , Humanos , Adulto , Estudios Prospectivos , Resucitación , Infusiones Intravenosas , Inyecciones Intravenosas , Infusiones Intraóseas
5.
CJEM ; 25(5): 421-428, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-37087711

RESUMEN

OBJECTIVE: Patient handover between paramedics and the trauma team is vulnerable to communication errors that may adversely affect patient care. This study assesses the feasibility of a handover tool, IMIST-AMBO (acronym of categories), implementation in the trauma bay and evaluates the degree to which it improves handover metrics. METHODS: This is a prospective observational cohort study conducted at Canada's largest level-one trauma center. Feasibility of the tool implementation and improvement in handover metrics were assessed. Strategies for implementation included distribution of an educational video and posters, and point-of-care reminders in the trauma bay. Two reviewers independently assessed video recordings of handovers to evaluate handover metrics. Findings were compared to data obtained during a knowledge gap analysis conducted prior to the initiation of this study at the same institution. RESULTS: Over 13 weeks (August to November 2020), 140 videos were recorded, of which 80 used the IMIST-AMBO tool (compliance of 57%). Paramedic adherence to the handover structure occurred in 70.4% of cases, with greater adherence to the IMIST (82.2%) compared to the AMBO (47.1%) section. The mean (± standard deviation) handover duration was shorter (1 min:58 s ± 0:44 s during implementation vs. 2 min:47 s ± 1:14 s pre-implementation, [p < 0.001]). Frequency of parallel conversations and informal handovers improved (61% to 30% and 65% to 13%, [p < 0.001], respectively). Interruptions during the handover decreased from 3.05 (± 1.95) to 1.5 (± 1.7), p < 0.001. The tool was received favorably among study participants. CONCLUSION: The IMIST-AMBO tool reduced the frequency of interruptions, parallel conversations, and informal handovers during paramedic-trauma team handovers at our institution. The quality and amount of information communicated per handover improved, all with a decrease in handover duration. The IMIST-AMBO tool may be applied to other trauma centers across Canada, or more broadly on an international scale.


RéSUMé: OBJECTIFS: Le transfert des patients entre les ambulanciers paramédicaux et l'équipe de traumatologie est vulnérable aux erreurs de communication qui peuvent nuire aux soins aux patients. Cette étude évalue la faisabilité d'un outil de transfert, IMIST-AMBO (acronyme des catégories), mis en œuvre dans le service de traumatologie et évalue dans quelle mesure il améliore les paramètres de transfert. MéTHODES: Il s'agit d'une étude de cohorte observationnelle prospective menée dans le plus grand centre de traumatologie de niveau 1 du Canada. La faisabilité de la mise en œuvre de l'outil et l'amélioration des paramètres de transfert ont été évaluées. Les stratégies de mise en œuvre comprenaient la distribution d'une vidéo et d'affiches éducatives, ainsi que des rappels au point de service dans la salle de traumatologie. Deux examinateurs ont évalué indépendamment les enregistrements vidéo des transferts pour évaluer les paramètres de transfert. Les résultats ont été comparés aux données obtenues lors d'une analyse des lacunes en matière de connaissances réalisée avant le lancement de cette étude dans le même établissement. RéSULTATS: Sur 13 semaines (août à novembre 2020), 140 vidéos ont été enregistrées, dont 80 ont utilisé l'outil IMIST-AMBO (conformité de 57%). L'adhésion des ambulanciers paramédicaux à la structure de transfert s'est produite dans 70.4% des cas, avec une plus grande adhésion à l'IMIST (82.2%) que l'AMBO (47,1%). La durée moyenne (± écart-type) du transfert était plus courte (1 min: 58 s ± 0: 44 s pendant la mise en œuvre contre 2 min: 47 s ± 1: 14 s avant la mise en œuvre, p < 0.001). La fréquence des conversations parallèles et des transferts informels s'est améliorée (de 61% à 30% et de 65% à 13%, [p < 0.001], respectivement). Les interruptions pendant le transfert ont diminué de 3.05 (± 1.95) à 1.5 (± 1.7), p < 0.001. L'outil a été accueilli favorablement par les participants à l'étude. CONCLUSION: L'outil IMIST-AMBO a réduit la fréquence des interruptions, des conversations parallèles et des transferts informels pendant les transferts de l'équipe paramédicale de traumatologie dans notre établissement. La qualité et la quantité d'informations communiquées par transfert se sont améliorées, tout en réduisant la durée du transfert. L'outil IMIST-AMBO peut être appliqué à d'autres centres de traumatologie à travers le Canada, ou plus largement à l'échelle internationale.


Asunto(s)
Auxiliares de Urgencia , Pase de Guardia , Humanos , Paramédico , Estudios de Cohortes , Comunicación , Continuidad de la Atención al Paciente
6.
Mil Med Res ; 10(1): 6, 2023 02 16.
Artículo en Inglés | MEDLINE | ID: mdl-36793066

RESUMEN

Artificial intelligence (AI), a branch of machine learning (ML) has been increasingly employed in the research of trauma in various aspects. Hemorrhage is the most common cause of trauma-related death. To better elucidate the current role of AI and contribute to future development of ML in trauma care, we conducted a review focused on the use of ML in the diagnosis or treatment strategy of traumatic hemorrhage. A literature search was carried out on PubMed and Google scholar. Titles and abstracts were screened and, if deemed appropriate, the full articles were reviewed. We included 89 studies in the review. These studies could be grouped into five areas: (1) prediction of outcomes; (2) risk assessment and injury severity for triage; (3) prediction of transfusions; (4) detection of hemorrhage; and (5) prediction of coagulopathy. Performance analysis of ML in comparison with current standards for trauma care showed that most studies demonstrated the benefits of ML models. However, most studies were retrospective, focused on prediction of mortality, and development of patient outcome scoring systems. Few studies performed model assessment via test datasets obtained from different sources. Prediction models for transfusions and coagulopathy have been developed, but none is in widespread use. AI-enabled ML-driven technology is becoming integral part of the whole course of trauma care. Comparison and application of ML algorithms using different datasets from initial training, testing and validation in prospective and randomized controlled trials are warranted for provision of decision support for individualized patient care as far forward as possible.


Asunto(s)
Inteligencia Artificial , Servicios Médicos de Urgencia , Humanos , Estudios Prospectivos , Estudios Retrospectivos , Aprendizaje Automático , Hemorragia/diagnóstico , Hemorragia/etiología , Hemorragia/terapia
8.
Emerg Med Clin North Am ; 41(1): 51-69, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36424044

RESUMEN

Damage-control resuscitation is the standard of care for the hemorrhaging trauma patient. This approach combines rapid hemostasis and early-ratio-based blood product administration. These patients often require initiation of a massive hemorrhage protocol to support the systematic and coordinated delivery of care during this critical phase of resuscitation. Emerging evidence supports that this includes more than blood product administration alone but rather a comprehensive suite of treatments. In this article, we review the existing evidence and provide a pragmatic framework, the 7 Ts of massive hemorrhage protocol, to guide the care of patients with life-threatening traumatic hemorrhage.


Asunto(s)
Hemorragia , Resucitación , Humanos , Hemorragia/diagnóstico , Hemorragia/terapia , Resucitación/métodos
9.
Injury ; 53(8): 2704-2716, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35773023

RESUMEN

BACKGROUND: Despite decades-long involvement of trauma survivors in hospital-based program delivery, their roles and impact on trauma care have not been previously described. We aimed to characterize the literature on trauma survivor involvement in hospital-based injury prevention, violence intervention and peer support programs to map what is currently known and identify future research opportunities. METHODS: A scoping review was conducted following the Joanna Briggs Institute (JBI) methodology. Articles were identified through electronic databases and gray literature. Included articles described hospital-based injury prevention programs, violence intervention programs and peer support programs that involved trauma survivors leveraging their injury experiences to counsel others. Studies were screened and data were abstracted in duplicate. Data were synthesized generally and by program type. RESULTS: Thirty-six published articles and four program reports were included. Peer support programs were described in 21 articles, mainly involving trauma survivors as mentors or peer supporters. Peer support programs' most commonly reported outcome was participant satisfaction (n = 6), followed by participant self-efficacy (n = 5), depression (n = 4), and community integration (n = 3). Eleven injury prevention studies were included, all involving trauma survivors as speakers in youth targeted programs. Injury prevention studies commonly reported outcomes of participants' risk behaviors and awareness (n = 9). Violence intervention programs were included in four articles involving trauma survivors as intervention counsellors. Recidivism rate was the most commonly reported outcome (n = 3). Variability exists across and within program types when reporting on involved trauma survivors' gender, age, selection and training, duration of involvement and number of survivors involved. Outcomes related to trauma survivors' own experiences and the impacts to them of program involvement were under-studied. CONCLUSIONS: Significant opportunity exists to fill current knowledge gaps in trauma survivors' involvement in trauma program delivery. There is a need to describe more fully who involved trauma survivors are to inform the development of effective future interventions.


Asunto(s)
Sobrevivientes , Violencia , Adolescente , Hospitales , Humanos , Violencia/prevención & control
10.
CJEM ; 24(4): 419-425, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-35412259

RESUMEN

OBJECTIVES: Communication among trauma team members in the trauma bay is vulnerable to errors, which may impact patient outcomes. We used the previously validated trauma-non-technical skills (T-NOTECHS) tool to identify communication gaps during patient management in the trauma bay and to inform development strategies to improve team performance. METHODS: Two reviewers independently assessed non-technical skills of team members through video footage at Sunnybrook Health Sciences Centre. Team performance was measured using T-NOTECHS across five domains using a five-point Likert scale (lower score indicating worse performance): (1) leadership; (2) cooperation and resource management; (3) communication and interaction; (4) assessment and decision making; (5) situation awareness/coping with stress. Secondary outcomes assessed the number of callouts, closed loop communications and parallel conversations. RESULTS: The study included 55 trauma activations. Injury severity score (ISS) was used as a measure of trauma severity. A case with an ISS score ≥ 16 was considered severe. ISS was ≥ 16 in 37% of cases. Communication and interaction scored significantly lower compared to all other domains (p < 0.0001). There were significantly more callouts and completed closed loop communications in more severe cases compared to less severe cases (p = 0.017 for both). Incomplete closed loop communications and parallel conversations were identified, irrespective of case severity. CONCLUSION: A lower communication score was identified using T-NOTECHS, attributed to incomplete closed loop communications and parallel conversations. Through video review of trauma team activations, opportunities for improvement in communication can be identified by the T-NOTECHS tool, as well as specifically identifying callouts and closed loop communication. This process may be useful for trauma programs as part of a quality improvement program on communication skills and team performance.


RéSUMé: OBJECTIFS : La communication entre les membres de l'équipe de traumatologie dans la salle de traumatologie est vulnérable aux erreurs, ce qui peut avoir un impact sur les résultats des patients. Nous avons utilisé l'outil de compétences non techniques en traumatologie (T-NOTECHS) précédemment validé pour identifier les lacunes en matière de communication pendant la prise en charge des patients dans la salle de traumatologie et pour informer les stratégies de développement visant à améliorer les performances de l'équipe. MéTHODES: Deux examinateurs ont évalué de manière indépendante les compétences non techniques des membres de l'équipe au moyen de séquences vidéo réalisées au Sunnybrook Health Sciences Centre. La performance de l'équipe a été mesurée à l'aide de la T-NOTECHS dans cinq domaines à l'aide d'une échelle de Likert à cinq points (un score plus bas indiquant une performance plus faible) : (1) leadership ; (2) coopération et gestion des ressources ; (3) communication et interaction ; (4) évaluation et prise de décision ; (5) conscience de la situation/ gestion du stress. Les résultats secondaires ont évalué le nombre d'appels, de communications en boucle fermée et de conversations parallèles. RéSULTATS: L'étude a porté sur 55 activations de traumatismes. Le score de gravité des blessures (ISS) a été utilisé comme mesure de la gravité du traumatisme. Un cas présentant un score ISS ≥ 16 était considéré comme grave. L'ISS était ≥ 16 dans 37 % des cas. La communication et l'interaction ont obtenu des scores significativement plus faibles par rapport à tous les autres domaines (p<0,0001). Il y avait significativement plus d'appels et de communications en boucle fermée terminées dans les cas plus graves que dans les cas moins graves (p = 0.017 pour les deux). Des communications incomplètes en boucle fermée et des conversations parallèles ont été identifiées, indépendamment de la gravité du cas. CONCLUSION: Un score de communication plus faible a été identifié en utilisant le T-NOTECHS, attribué à des communications incomplètes en boucle fermée et à des conversations parallèles. Grâce à l'examen vidéo des activations de l'équipe de traumatologie, les possibilités d'amélioration de la communication peuvent être identifiées par l'outil T-NOTECHS, ainsi que l'identification spécifique des appels et de la communication en boucle fermée. Ce processus peut être utile pour les programmes de traumatologie dans le cadre d'un programme d'amélioration de la qualité sur les compétences de communication et la performance de l'équipe.


Asunto(s)
Grupo de Atención al Paciente , Método Teach-Back , Competencia Clínica , Comunicación , Humanos , Liderazgo , Resucitación
11.
Trauma Surg Acute Care Open ; 6(1): e000773, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34746434

RESUMEN

OBJECTIVES: The Tactical Combat Casualty Care (TCCC) guidelines detail resuscitation practices in prehospital and austere environments. We sought to review the content and quality of the current TCCC and civilian prehospital literature and characterize knowledge gaps to offer recommendations for future research. METHODS: MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials were searched for studies assessing intervention techniques and devices used in civilian and military prehospital settings that could be applied to TCCC guidelines. Screening and data extraction were performed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Quality appraisal was conducted using appropriate tools. RESULTS: Ninety-two percent (n=57) of studies were observational. Most randomized trials had low risk of bias, whereas observational studies had higher risk of bias. Interventions of massive hemorrhage control (n=17) were wound dressings and tourniquets, suggesting effective hemodynamic control. Airway management interventions (n=7) had high success rates with improved outcomes. Interventions of respiratory management (n=12) reported low success with needle decompression. Studies assessing circulation (n=18) had higher quality of evidence and suggested improved outcomes with component hemostatic therapy. Hypothermia prevention interventions (n=2) were generally effective. Other studies identified assessed the use of extended focused assessment with sonography in trauma (n=3) and mixed interventions (n=2). CONCLUSIONS: The evidence was largely non-randomized with heterogeneous populations, interventions, and outcomes, precluding robust conclusions in most subjects addressed in the review. Knowledge gaps identified included the use of blood products and concentrate of clotting factors in the prehospital setting. LEVEL OF EVIDENCE: Systematic review, level III.

12.
BMJ Open ; 11(9): e051003, 2021 09 03.
Artículo en Inglés | MEDLINE | ID: mdl-34479938

RESUMEN

INTRODUCTION: Acute traumatic coagulopathy (ATC) in bleeding trauma patients increase in-hospital mortality. Fibrinogen concentrate (FC) and prothrombin complex concentrate (PCC) are two purified concentrates of clotting factors that have been used to treat ATC. However, there is a knowledge gap on their use compared with the standard of care, the transfusion of plasma. METHODS AND ANALYSIS: The factors in the initial resuscitation of severe trauma 2 trial is a multicentre, randomised, parallel-control, single-blinded, phase IV superiority trial. The study aims to address efficacy and safety of the early use of FC and PCC compared with a plasma-based resuscitation. Adult trauma patients requiring massive haemorrhage protocol activation on hospital arrival will receive FC 4 g and PCC 2000 IU or plasma 4 U, based on random allocation. The primary outcome is a composite of the cumulative number of all units of red cells, plasma and platelets transfused within 24 hours following admission. Secondary outcomes include measures of efficacy and safety of the intervention. Enrolment of 350 patients will provide an initial power >80% to demonstrate superiority for the primary outcome. After enrolment of 120 patients, a preplanned adaptive interim analysis will be conducted to reassess assumptions, check for early superiority demonstration or reassess the sample size for remainder of the study. ETHICS AND DISSEMINATION: The study has been approved by local and provincial research ethics boards and will be conducted according to the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. As per the Tri-Council Policy Statement, patient consent will be deferred due to the emergency nature of the interventions. If superiority is established, results will have a major impact on clinical practice by reducing exposure to non-virally inactivated blood products, shortening the time for administration of clotting factors, correct coagulopathy more efficaciously and reduce the reliance on AB plasma. TRIAL REGISTRATION NUMBER: NCT04534751, pre results.


Asunto(s)
Trastornos de la Coagulación Sanguínea , Hemostáticos , Trastornos de la Coagulación Sanguínea/tratamiento farmacológico , Transfusión Sanguínea , Fibrinógeno , Hemorragia/tratamiento farmacológico , Humanos , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
13.
Transfusion ; 61 Suppl 1: S49-S57, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-34269460

RESUMEN

BACKGROUND: Coagulopathic bleeding is frequently present after major trauma. However, trauma-induced coagulopathy (TIC) remains incompletely understood. This laboratory analysis of blood samples derived from our completed trial on fibrinogen in the initial resuscitation of severe trauma (FiiRST) was conducted to evaluate TIC and associated responses to fibrinogen replacement. STUDY DESIGN AND METHODS: We conducted a retrospective evaluation of TIC in 45 FiiRST trial patients based on rotational thromboelastometry (ROTEM), international normalized ratio (INR), and biomarkers for hemostasis and endotheliopathy. Whole blood was analyzed by ROTEM. Plasma was analyzed for INR and biomarkers. RESULTS: Overall, 19.0% and 30.0% of the FiiRST trial patients were coagulopathic on admission defined by EXTEM maximum clot firmness out of the range of 40-71 mm and INR >1.2, respectively. The FiiRST patients showed lower fibrinogen, factor II and V levels, protein C and antiplasmin activities, higher activated protein C, tissue plasminogen activator, d-dimer, and thrombomodulin concentrations at admission than healthy controls. Most of the biomarkers changed their activities during 48-h hospitalization, but were at abnormal levels even 48-h after admission. The fibrinogen treatment reduced hypofibrinogenemia and increased factor XIII level, but had no significant effects on other biomarkers levels. Limited development of endotheliopathy was indicated by syndean-1, thrombomodulin, and sE-selectin. CONCLUSIONS: About 19%-30% of the trauma patients in the FiiRST trial were coagulopathic on hospital admission depending on the definition of TIC. Analyses of the TIC biomarkers demonstrated that hemostasis would not return to normal after 48-h hospitalization, and fibrinogen replacement improved hypofibrinogenemia.


Asunto(s)
Trastornos de la Coagulación Sanguínea/etiología , Trastornos de la Coagulación Sanguínea/terapia , Fibrinógeno/uso terapéutico , Resucitación/métodos , Heridas y Lesiones/complicaciones , Heridas y Lesiones/terapia , Adulto , Trastornos de la Coagulación Sanguínea/sangre , Femenino , Fibrinógeno/análisis , Humanos , Relación Normalizada Internacional , Masculino , Persona de Mediana Edad , Tromboelastografía , Heridas y Lesiones/sangre , Adulto Joven
14.
J Trauma Acute Care Surg ; 90(3): 589-602, 2021 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-33507025

RESUMEN

BACKGROUND: Treatment of acute trauma coagulopathy has shifted toward rapid replacement of coagulation factors with frozen plasma (FP). There are logistic difficulties in providing FP. Freeze-dried plasma (FDP) may have logistical advantages including easier storage and rapid preparation time. This review assesses the feasibility, efficacy, and safety of FDP in trauma. STUDY DESIGN AND METHODS: Studies were searched from Medline, Embase, Cochrane Controlled Trials Register, ClinicalTrials.gov, and Google Scholar. Observational and randomized controlled trials (RCTs) assessing FDP use in trauma were included. Trauma animal models addressing FDP use were also included. Bias was assessed using validated tools. Primary outcome was efficacy, and secondary outcomes were feasibility and safety. Meta-analyses were conducted using random-effect models. Evidence was graded using Grading of Recommendations Assessment, Development, and Evaluation profile. RESULTS: Twelve human studies (RCT, 1; observational, 11) and 15 animal studies were included. Overall, studies demonstrated moderate risk of bias. Data from two studies (n = 119) were combined for meta-analyses for mortality and transfusion of allogeneic blood products (ABPs). For both outcomes, no difference was identified. For mortality, pooled odds ratio was 0.66 (95% confidence interval, 0.29-1.49), with I2 = 0%. Use of FDP is feasible, and no adverse events were reported. Animal data suggest similar results for coagulation and anti-inflammatory profiles for FP and FDP. CONCLUSION: Human data assessing FDP use in trauma report no difference in mortality and transfusion of ABPs in patients receiving FDP compared with FP. Data from animal trauma studies report no difference in coagulation factor and anti-inflammatory profiles between FP and FDP. Results should be interpreted with caution because most studies were observational and have heterogeneous population (military and civilian trauma) and a moderate risk of bias. Well-designed prospective observational studies or, preferentially, RCTs are warranted to answer FDP's effect on laboratory (coagulation factor levels), transfusion (number of ABPs), and clinical outcomes (organ dysfunction, length of stay, and mortality). LEVEL OF EVIDENCE: Systematic review and meta-analysis, level IV.


Asunto(s)
Conservación de la Sangre , Transfusión Sanguínea , Plasma , Heridas y Lesiones/terapia , Animales , Modelos Animales de Enfermedad , Liofilización , Humanos
15.
Ann Surg ; 273(6): e239-e246, 2021 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-30985368

RESUMEN

OBJECTIVE: To appraise the quality of reporting on guideline, protocol, and algorithm implementations in adult trauma settings according to the Revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0). BACKGROUND: At present we do not know if published reports of guideline implementations in trauma settings are of sufficient quality to facilitate replication by other centers wishing to implement the same or similar guidelines. METHODS: A systematic review of the literature was conducted. Articles were identified through electronic databases and hand searching relevant trauma journals. Studies meeting inclusion criteria focused on a guideline, protocol, or algorithm that targeted adult trauma patients ≥18 years and/or trauma patient care providers, and evaluated the effectiveness of guideline, protocol, or algorithm implementation in terms of change in clinical practice or patient outcomes. Each included study was assessed in duplicate for adherence to the 18-item SQUIRE 2.0 criteria. The primary endpoint was the proportion of studies meeting at least 80% (score ≥15) of SQUIRE 2.0. RESULTS: Of 7368 screened studies, 74 met inclusion criteria. Thirty-nine percent of studies scored ≥80% on SQUIRE 2.0. Criteria that were met most frequently were abstract (93%), problem description (93%), and specific aims (89%). The lowest scores appeared in the funding (28%), context (47%), and results (54%) criteria. No study indicated using SQUIRE 2.0 as a guideline to writing the report. CONCLUSIONS: Significant opportunity exists to improve the utility of guideline implementation reports in adult trauma settings, particularly in the domains of study context and the implications of context for study outcomes.


Asunto(s)
Algoritmos , Protocolos Clínicos , Exactitud de los Datos , Adhesión a Directriz/estadística & datos numéricos , Proyectos de Investigación/normas , Centros Traumatológicos , Adulto , Humanos
17.
CJEM ; 22(S2): S21-S29, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-33084560

RESUMEN

OBJECTIVES: There has been limited evaluation of handover from emergency medical services (EMS) to the trauma team. We sought to characterize these handover practices to identify areas of improvement and determine if handover standardization might be beneficial for trauma team performance. METHODS: Data were prospectively collected over a nine-week period by a trained observer at a Canadian level one trauma centre. A randomized scheduled was used to capture a representative breadth of handovers. Data collected included outcome measures such as duration of handover, structure of the handover, and information shared, process measures such as questions and interruptions from the trauma team, and perceptions of the handover from nurses, trauma team leaders and EMS according to a bidirectional Likert scale. RESULTS: 79 formal verbal handovers were observed. Information was often missing regarding airway (present 22%), breathing (54%), medications (59%), and allergies (54%). Handover structure lacked consistency beyond the order of identification and mechanism of injury. Of all questions asked, 35% were questioning previously given information. The majority of handovers (61%) involved parallel conversations between team members while EMS was speaking. There was a statistically significant disparity between the self-evaluation of EMS handovers and the perceived quality determined by nurses and trauma team leaders. CONCLUSIONS: We have identified the need to standardize handover due to poor information content, a lack of structure and active listening, information repetition, and discordant expectations between team members. These data will guide the development of a co-constructed framework integrating the perspectives of all team members.


Asunto(s)
Servicios Médicos de Urgencia , Pase de Guardia , Canadá , Comunicación , Humanos
18.
CJEM ; 22(S2): S89-S103, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-33084563

RESUMEN

OBJECTIVES: Military Forward Aeromedical Evacuation and civilian Helicopter Emergency Medical Services are widely used to conduct Primary Aeromedical Retrieval. Crew composition in Primary Aeromedical Retrieval missions varies considerably. The ideal composition is unknown. Thus, we conducted a descriptive systematic review on mortality and other outcomes for different Primary Aeromedical Retrieval crew compositions. METHODS: Medline, Embase, and Cochrane Controlled Trials Register were searched up to January 2020. Results were reported per Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Studies of adult trauma air transported by different crews were included. Population, injury severity, crew composition, procedures, and outcomes, including mortality, were abstracted. Risk of bias was assessed using previously validated tools. A lack of reported effect measures precluded a quantitative analysis. RESULTS: Sixteen studies met inclusion criteria (3 prospective studies, 1 case-control, and 12 retrospective). Overall, studies reported a mortality benefit associated with advanced health care providers. This was most apparent in patients with severe but survivable injuries. In this population, early rapid sequence induction, endotracheal intubation, mechanical ventilation, thoracostomies, blood products transfusion, and treatment of hemorrhagic shock are better performed by advanced providers and may improve outcomes. The quality of evidence reported a moderate risk of bias in the included studies. CONCLUSIONS: Overall, findings were divergent but showed a trend to decreased mortality in patients treated by advanced providers with interventions beyond the basic paramedic level. This trend was most significant in patients with severe but survivable injuries. These results should be cautiously interpreted because most studies were observational, had small sample sizes, and had a high potential for confounding factors.


Asunto(s)
Ambulancias Aéreas , Aeronaves , Humanos , Estudios Prospectivos , Estudios Retrospectivos
19.
CJEM ; 22(S2): S4-S11, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-33084562

RESUMEN

OBJECTIVES: The management of acquired coagulopathy in multiple clinical settings frequently involves fibrinogen supplementation. Cryoprecipitate, a multidonor product, is widely used for the treatment of acquired hypofibrinogenemia following massive bleeding, but it has been associated with adverse events. We aimed to review the latest evidence on cryoprecipitate for treatment of bleeding. METHODS: We conducted a narrative review of current literature on cryoprecipitate therapy, describing its history, formulations and preparation, and recommended dosing. We also reviewed guideline recommendations on the use of cryoprecipitate in bleeding situations and recent studies on its efficacy and safety. RESULTS: Cryoprecipitate has a relatively high fibrinogen content; however, as it is produced by pooling fresh frozen donor plasma, the fibrinogen content per unit can vary considerably. Current guidelines suggest that cryoprecipitate use should be limited to treating hypofibrinogenemia in patients with clinical bleeding. Until recently, cryoprecipitate was deemed unsuitable for pathogen reduction, and potential safety concerns and lack of standardized fibrinogen content have led to some professional bodies recommending that cryoprecipitate is only indicated for the treatment of bleeding and hypofibrinogenemia in perioperative settings where fibrinogen concentrate is not available. While cryoprecipitate is effective in increasing plasma fibrinogen levels, data on its clinical efficacy are limited. CONCLUSIONS: There is a lack of robust evidence to support the use of cryoprecipitate in bleeding patients, with few prospective, randomized clinical trials performed to date. Clinical trials in bleeding settings are needed to investigate the safety and efficacy of cryoprecipitate and to determine its optimal use and administration.


Asunto(s)
Hemorragia , Transfusión Sanguínea , Factor VIII , Fibrinógeno/análisis , Hemorragia/terapia , Humanos , Estudios Prospectivos
20.
Transfusion ; 59(11): 3337-3349, 2019 11.
Artículo en Inglés | MEDLINE | ID: mdl-31614006

RESUMEN

BACKGROUND: Deaths by exsanguination in trauma are preventable with hemorrhage control and resuscitation with allogeneic blood products (ABPs). The ideal transfusion ratio is unknown. We compared efficacy and safety of high transfusion ratios of FFP:RBC and PLT:RBC with low ratios in trauma. STUDY DESIGN AND METHODS: Medline, Embase, Cochrane, and Controlled Clinical Trials Register were searched. Observational and randomized data were included. Risk of bias was assessed using validated tools. Primary outcome was 24-h and 30-day mortality. Secondary outcomes were exposure to ABPs and improvement of coagulopathy. Meta-analysis was conducted using a random-effects model. Strength and evidence quality were graded using GRADE profile RESULTS: 55 studies were included (2 randomized and 53 observational), with low and moderate risk of bias, respectively, and overall low evidence quality. The two RCTs showed no mortality difference (odds ratio [OR], 1.35; 95% confidence interval [CI], 0.40-4.59). Observational studies reported lower mortality in high FFP:RBCs ratio (OR, 0.38 [95% CI, 0.22-0.68] for 1:1 vs. <1:1; OR, 0.42 [95% CI, 0.22-0.81] for 1:1.5 vs. <1:1.5; and OR, 0.47 [95% CI, 0.31-0.71] for 1:2 vs. <1:2, respectively). Meta-analyses in observational studies showed no difference in exposure to ABPs. No data on coagulopathy for meta-analysis was identified. CONCLUSIONS: Meta-analyses in observational studies suggest survival benefit and no difference in exposure to ABPs. No survival benefit in RCTs was identified. These conflicting results should be interpreted with caution. Studies are mostly observational, with relatively small sample sizes, nonrandom treatment allocation, and high potential for confounding. Further research is warranted.


Asunto(s)
Transfusión de Eritrocitos , Intercambio Plasmático , Transfusión de Plaquetas , Heridas y Lesiones/terapia , Humanos , Heridas y Lesiones/mortalidad
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