Intraoperative tranexamic acid use in major spine surgery in adults: a multicentre, randomized, placebo-controlled trial†.

Background: Perioperative tranexamic acid (TXA) use can reduce bleeding and transfusion requirements in several types of surgery, but level I evidence proving its effectiveness in major spine surgery is lacking. This study was designed to investigate the hypothesis that TXA reduces perioperative blood loss and transfusion requirements in patients undergoing major spine procedures. Methods: We conducted a multicentre, prospective, randomized double-blind clinical trial, comparing TXA with placebo in posterior instrumented spine surgery. Efficacy was determined based on the total number of blood units transfused and the perioperative blood loss. Other variables such as the characteristics of surgery, length of hospital stay, and complications were also analysed. Results: Ninety-five patients undergoing posterior instrumented spine surgery (fusion of >3 segments) were enrolled and randomized: 44 received TXA (TXA group) and 51 received placebo (controls). The groups were comparable for duration of surgery, number of levels fused, and length of hospitalization. Transfusion was not required in 48% of subjects receiving TXA compared with 33% of controls (P = 0.05). Mean number of blood units transfused was 0.85 in the TXA group and 1.42 with placebo (P = 0.06). TXA resulted in a significant decrease in intraoperative bleeding (P = 0.01) and total bleeding (P = 0.01) relative to placebo. The incidence of adverse events was similar in the two groups. Conclusions: TXA did not significantly reduce transfusion requirements, but significantly reduced perioperative blood loss in adults undergoing major spinal surgery. Clinical trial registration: NCT01136590.

Fluid resuscitation management in patients with burns: update.

Since 1968, when Baxter and Shires developed the Parkland formula, little progress has been made in the field of fluid therapy for burn resuscitation, despite advances in haemodynamic monitoring, establishment of the 'goal-directed therapy' concept, and the development of new colloid and crystalloid solutions. Burn patients receive a larger amount of fluids in the first hours than any other trauma patients. Initial resuscitation is based on crystalloids because of the increased capillary permeability occurring during the first 24 h. After that time, some colloids, but not all, are accepted. Since the emergence of the Pharmacovigilance Risk Assessment Committee alert from the European Medicines Agency concerning hydroxyethyl starches, solutions containing this component are not recommended for burns. But the question is: what do we really know about fluid resuscitation in burns? To provide an answer, we carried out a non-systematic review to clarify how to quantify the amount of fluids needed, what the current evidence says about the available solutions, and which solution is the most appropriate for burn patients based on the available knowledge.

Forum for debate: Safety of allogeneic blood transfusion alternatives in the surgical/critically ill patient.

In recent years, several safety alerts have questioned or restricted the use of some pharmacological alternatives to allogeneic blood transfusion in established indications. In contrast, there seems to be a promotion of other alternatives, based on blood products and/or antifibrinolytic drugs, which lack a solid scientific basis. The Multidisciplinary Autotransfusion Study Group and the Anemia Working Group España convened a multidisciplinary panel of 23 experts belonging to different healthcare areas in a forum for debate to: 1) analyze the different safety alerts referred to certain transfusion alternatives; 2) study the background leading to such alternatives, the evidence supporting them, and their consequences for everyday clinical practice, and 3) issue a weighted statement on the safety of each questioned transfusion alternative, according to its clinical use. The members of the forum maintained telematics contact for the exchange of information and the distribution of tasks, and a joint meeting was held where the conclusions on each of the items examined were presented and discussed. A first version of the document was drafted, and subjected to 4 rounds of review and updating until consensus was reached (unanimously in most cases). We present the final version of the document, approved by all panel members, and hope it will be useful for our colleagues.

[The 2013 Seville Consensus Document on alternatives to allogenic blood transfusion. An update on the Seville Document]. / 2013. Documento Sevilla de Consenso sobre Alternativas a la Transfusión de Sangre Alogénica. Actualización del Documento Sevilla.

Since allogeneic blood transfusion (ABT) is not harmless, multiple alternatives to ABT (AABT) have emerged, though there is great variability in their indications and appropriate use. This variability results from the interaction of a number of factors, including the specialty of the physician, knowledge and preferences, the degree of anemia, transfusion policy, and AABT availability. Since AABTs are not harmless and may not meet cost-effectiveness criteria, such variability is unacceptable. The Spanish Societies of Anesthesiology (SEDAR), Hematology and Hemotherapy (SEHH), Hospital Pharmacy (SEFH), Critical Care Medicine (SEMICYUC), Thrombosis and Hemostasis (SETH) and Blood Transfusion (SETS) have developed a Consensus Document for the proper use of AABTs. A panel of experts convened by these 6 Societies have conducted a systematic review of the medical literature and have developed the 2013 Seville Consensus Document on Alternatives to Allogeneic Blood Transfusion, which only considers those AABT aimed at decreasing the transfusion of packed red cells. AABTs are defined as any pharmacological or non-pharmacological measure aimed at decreasing the transfusion of red blood cell concentrates, while preserving patient safety. For each AABT, the main question formulated, positively or negatively, is: « Does this particular AABT reduce the transfusion rate or not?¼ All the recommendations on the use of AABTs were formulated according to the Grades of Recommendation Assessment, Development and Evaluation (GRADE) methodology.

Use of viscoelastic tests in the principle bleeding scenarios in Spanish hospitals.

Viscoelastic tests are designed to study the dynamics of clot formation, identify coagulopathies in real time, arrive at a diagnosis, and guide patient-specific administration of haemostatics. They are mainly used to treat clinically significant bleeding in any setting, and are also used in other situations involving clinically relevant alterations in haemostasis, such as coagulopathy in critically ill patients. These tests are administered following evidence-based algorithms that vary depending on the clinical context. This review summarises the results of a survey conducted in several hospitals to determine the prevalence and standardisation of viscoelastic tests in cardiac surgery, liver transplantation, and multiple trauma patients in Spain. The results reveal divergent opinions on key aspects, ranging from the diagnostic capacity of these tests to the interpretation of the basic parameters. On the basis of these findings, we propose a number of potential areas in which further research will improve the performance of these tests.

Fluid challenges in operating room: A planned sub study of the Fluid Day observational study.

BACKGROUND: Intraoperative fluid administration is a ubiquitous intervention in surgical patients. But inadequate fluid administration may lead to poor postoperative outcomes. Fluid challenges (FCs), in or outside the so-called goal-directed fluid therapy, allows testing the cardiovascular system and the need for further fluid administration. Our primary aim was to evaluate how anesthesiologists conduct FCs in the operating room in terms of type, volume, variables used to trigger a FC and to compare the proportion of patients receiving further fluid administration based on the response to the FC. METHODS: This was a planned substudy of an observational study conducted in 131 centres in Spain in patients undergoing surgery. RESULTS: A total of 396 patients were enrolled and analysed in the study. The median [interquartile range] amount of fluid given during a FC was 250ml (200-400). The main indication for FC was a decrease in systolic arterial pressure in 246 cases (62.2%). The second was a decrease in mean arterial pressure (54.4%). Cardiac output was used in 30 patients (7.58%), while stroke volume variation in 29 of 385 cases (7.32%). The response to the initial FC did not have an impact when prescribing further fluid administration. CONCLUSIONS: The current indication and evaluation of FC in surgical patients is highly variable. Prediction of fluid responsiveness is not routinely used, and inappropriate variables are frequently evaluated for assessing the hemodynamic response to FC, which may result in deleterious effects.

A critical review of the perioperative fluid therapy and hemodynamic monitoring recommendations of the Enhanced Recovery of the Adult Pathway (RICA): A position statement of the fluid therapy and hemodynamic monitoring Subcommittee of the Hemostasis, Transfusion Medicine and Fluid Therapy Section (SHTF) of the Spanish Society of Anesthesiology and Critical Care (SEDAR).

In an effort to standardize perioperative management and improve postoperative outcomes of adult patients undergoing surgery, the Ministry of Health, through the Spanish Multimodal Rehabilitation Group (GERM), and the Aragonese Institute of Health Sciences, in collaboration with multiple Spanish scientific societies and based on the available evidence, published in 2021 the Spanish Intensified Adult Recovery (RICA) guideline. This document includes 12 perioperative measures related to fluid therapy and hemodynamic monitoring. Fluid administration and hemodynamic monitoring are not straightforward but are directly related to postoperative patient outcomes. The Fluid Therapy and Hemodynamic Monitoring Subcommittee of the Hemostasis, Transfusion Medicine and Fluid Therapy Section (SHTF) of the Spanish Society of Anesthesiology and Critical Care (SEDAR) has reviewed these recommendations and concluded that they should be revised as they do not follow an adequate methodology.

Research priorities in perioperative fluid therapy and hemodynamic monitoring: A Delphi Consensus Survey from the Fluid Therapy and Hemodynamic Monitoring Subcommittee of the Hemostasis, Transfusion Medicine and Fluid Therapy Section (SHTF) of the Spanish Society of Anesthesiology and Critical Care (SEDAR).

BACKGROUND: Research in fluid therapy and perioperative hemodynamic monitoring is difficult and expensive. The objectives of this study were to summarize these topics and to prioritize these topics in order of research importance. METHODS: Electronic structured Delphi questionnaire over three rounds among 30 experts in fluid therapy and hemodynamic monitoring identified through the Fluid Therapy and Hemodynamic Monitoring Subcommittee of the Hemostasis, Transfusion Medicine and Fluid Therapy Section of the Spanish Society of Anesthesiology and Critical Care. RESULTS: 77 topics were identified and ranked in order of prioritization. Topics were categorized into themes of crystalloids, colloids, hemodynamic monitoring and others. 31 topics were ranked as essential research priority. To determine whether intraoperative hemodynamic optimization algorithms based on the invasive or noninvasive Hypotension Prediction Index versus other management strategies could decrease the incidence of postoperative complications. As well as whether the use of renal stress biomarkers together with a goal-directed fluid therapy protocol could reduce hospital stay and the incidence of acute kidney injury in adult patients undergoing non-cardiac surgery, reached the highest consensus. CONCLUSIONS: The Fluid Therapy and Hemodynamic Monitoring Subcommittee of the Hemostasis, Transfusion Medicine and Fluid Therapy Section of the Spanish Society of Anesthesiology and Critical Care will use these results to carry out the research.

Patient blood management in Europe.

Preoperative anaemia is common in patients undergoing orthopaedic and other major surgery. Anaemia is associated with increased risks of postoperative mortality and morbidity, infectious complications, prolonged hospitalization, and a greater likelihood of allogeneic red blood cell (RBC) transfusion. Evidence of the clinical and economic disadvantages of RBC transfusion in treating perioperative anaemia has prompted recommendations for its restriction and a growing interest in approaches that rely on patients' own (rather than donor) blood. These approaches are collectively termed 'patient blood management' (PBM). PBM involves the use of multidisciplinary, multimodal, individualized strategies to minimize RBC transfusion with the ultimate goal of improving patient outcomes. PBM relies on approaches (pillars) that detect and treat perioperative anaemia and reduce surgical blood loss and perioperative coagulopathy to harness and optimize physiological tolerance of anaemia. After the recent resolution 63.12 of the World Health Assembly, the implementation of PBM is encouraged in all WHO member states. This new standard of care is now established in some centres in the USA and Austria, in Western Australia, and nationally in the Netherlands. However, there is a pressing need for European healthcare providers to integrate PBM strategies into routine care for patients undergoing orthopaedic and other types of surgery in order to reduce the use of unnecessary transfusions and improve the quality of care. After reviewing current PBM practices in Europe, this article offers recommendations supporting its wider implementation, focusing on anaemia management, the first of the three pillars of PBM.

[Thromboprophylaxis in multiple trauma and head injury patients]. / Tromboprofilaxis en el paciente politraumatizado y con traumatismo craneoencefálico.

Venous thromboembolic disease (VTD) is a frequent condition with serious clinical consequences and elevated mortality related to underdiagnosis or undertreatment, especially in patients with multiple trauma. The incidence of VTD in these patients ranges from 5% to 58% and thromboprophylaxis is considered essential for proper management. Traditionally, pelvic and lower extremity fractures, head injury, and prolonged immobilization have been cited as risk factors for VTD; however, how these factors combine with others to predict high risk is still unclear. The best way to approach VTD prophylaxis in multiple trauma patients is currently unclear. Both mechanical and pharmacologic means are available. The main clinical practice guidelines recommend thromboprophylaxis with low-molecular weight heparin, which can be started 48 hours after trauma, unless patients are still bleeding, in which case mechanical compression is recommended in spite of the limited effectiveness of that measure. Compression is maintained until the risk of hemorrhage has diminished. There is insufficient evidence to support routine use of ultrasound imaging or venography. In patients with head injury who are at risk for intracranial bleeding, the use of low-molecular weight heparin should be delayed until risk disappears but mechanical prophylaxis (compression) can be considered according to clinical status.

Development of concomitant diseases in COVID-19 critically ill patients. / Desarrollo de enfermedades concomitantes en pacientes críticos con COVID-19.

It may be necessary a consideration about the best approach to the acute concomitant problems that critical COVID-19 patients can develop. They require a rapid diagnosis and an early treatment by a multidisciplinary team. As a result, we would like to describe two clinical cases a patient with diagnosis of COVID-19 pneumonia with good respiratory evolution that, after extubation suffered an acalculous cholecystitis and a patient with COVID-19 pneumonia that suffered an overinfection with necrotising pneumonia that presented with haemoptysis and was finally treated with arterial embolisation by the interventional radiologist's team.

Consensus document for multimodal intraoperatory neurophisiological monitoring in neurosurgical procedures. Basic fundamentals. / Documento de consenso para la monitorización neurofisiológica intraoperatoria multimodal en procedimientos neuroquirúrgicos. Fundamentos básicos.

The present work aims to establish a guide to action, agreed by anaesthesiologists and neurophysiologists alike, to perform effective intraoperative neurophysiological monitoring for procedures presenting a risk of functional neurological injury, and neurosurgical procedures. The first section discusses the main techniques currently used for intraoperative neurophysiological monitoring. The second exposes the anaesthetic and non-anaesthetic factors that are likely to affect the electrical records of the nervous system structures. This section is followed by an analysis detailing the adverse effects associated with the most common techniques and their use. Finally, the last section describes a series of guidelines to be followed upon the various intraoperative clinical events.

Muscle dysfunction and exercise limitation in adolescent idiopathic scoliosis.

Adolescent idiopathic scoliosis (AIS) can lead to ventilatory restriction, respiratory muscle weakness and exercise limitation. However, both the causes and the extent of muscle dysfunction remain unclear. The aim of our study is to describe muscle weakness and its relationship to lung function and tolerance to exercise in AIS patients. Lung and muscle function, together with exercise capacity, were assessed in 60 patients with pronounced spinal deformity (>40 degrees) and in 25 healthy volunteers. Patients with AIS had only mild to moderate abnormal ventilatory patterns, the most frequent of which were restrictive abnormalities. The function of respiratory and limb muscles and exercise capacity were below normal limits in AIS patients, and were significantly lower than in controls. Exercise capacity was found to correlate with the function of inspiratory, expiratory, upper limb and lower limb muscles which, in addition, were reciprocally interrelated. Multivariate analysis showed that lower limb muscle function is the main contributor to exercise intolerance. There appeared to be no connection between spinal deformity and lung function, muscle function or exercise capacity. We conclude that AIS patients show generalised muscle dysfunction which contributes to the reduction in their exercise capacity, even in the absence of severe ventilatory impairment.

[Health policy strategies for Patient Blood Management implementation throughout the Spanish health systems]. / Estrategias de gestión y política sanitaria para el desarrollo del Patient Blood Management en los sistemas de salud en España.

Patient Blood Management (PBM) programs have proven to be successful in reducing overuse and improving patient safety, clinical outcomes and efficiency. Despite its benefits, PBM is still scarcely used in real clinical practice with a high variability among hospitals in Spain. Recent guidelines from the European Union on how to implement PBM, as well as recommendations from experts in the field, suggest that further development in PBM implementation requires not only the participation of healthcare professionals but also the commitment and support of Health Authorities and senior hospital management. This article provides some thoughts on health care management and policy strategies to help implement PBM throughout the Spanish autonomous healthcare systems.

Assessment of the knowledge level of the professional as regards Patient Blood Management in their organisation. Results of the MAPBM project survey. / Valoración del grado de conocimiento de los profesionales sobre el Patient Blood Management en su organización. Modelo y resultados de la encuesta del proyecto MAPBM.

INTRODUCTION: The Maturity Assessment Model in Patient Blood Management project involves the use of a matrix that evaluates the maturity of the centre as regards blood transfusion practice. This tool includes a questionnaire to be completed by physicians to determine their level of knowledge of patient blood management strategies in their centre. MATERIAL AND METHODS: Forty one hospitals took part in the Maturity Assessment Model in Patient Blood Management project in 2016. The questionnaire included 10 questions, 3 about the centre, specialty, and years of experience, and 7 about patient blood management protocols in the respondent's centre. The minimum responses required per centre was calculated according to the number of beds. Responses from at least 3 different specialties were required in order to be evaluated. RESULTS: A total of 1403 questionnaires were completed. The specialty with the highest completion rate was anaesthesiology (40.9%). The distribution as regards professional experience was homogeneous: <10 years, 33.4%, 10-20 years, 33%, and> 20 years 33.6%. Nearly three-quarters (74.2%) knew the patient blood management protocol used in their centre, and 60.7% knew the protocol for the treatment of pre-operative anaemia. Slightly fewer (72%) reported knowing the blood transfusion protocol (transfusion threshold) used in their centre, and 90% considered other factors besides haemoglobin in the decision to transfuse. Only 30.7% of professionals reported receiving periodic information on transfusion practices. CONCLUSIONS: There is a significant lack of knowledge about preoperative anaemia and perioperative transfusion protocols used in the centres polled. Few centres provide their physicians with information on transfusion practices.

Clinical practice guide for the choice of perioperative volume-restoring fluid in adult patients undergoing non-cardiac surgery.

The present Clinical practice guide responds to the clinical questions about security in the choice of fluid (crystalloid, colloid or hydroxyethyl starch 130) in patients who require volume replacement during perioperative period of non-cardiac surgeries. From the evidence summary, recommendations were made following the GRADE methodology. In this population fluid therapy based on crystalloids is suggested (weak recommendation, low quality evidence). In the events where volume replacement is not reached with crystalloids, the use of synthetic colloids (hydroxyethyl starch 130 or modified fluid gelatin) is suggested instead of 5% albumin (weak recommendation, low quality evidence). The choice and dosage of the colloid should be based in the product characteristics, patient comorbidity and anesthesiologist's experience.

Analysis of nutritional parameters in idiopathic scoliosis patients after major spinal surgery.

OBJECTIVE: The aim of the study is to investigate the evolution of nutritional parameters after major spinal surgery in patients with idiopathic scoliosis. METHODS: This retrospective study included 31 patients with a mean age of 18 y, diagnosed with idiopathic scoliosis. The following variables were analyzed: demographic, surgical (type, number of fused segments, duration, and blood loss), nutritional assessment (proteins, albumin, prealbumin, transferrin, lymphocytes, and body mass index), and duration of hospitalization at different time points. Statistical analyses were performed with the SPSS 6.1 software. RESULTS: Before surgery, nutritional status was normal in all patients. At 24-48 h after surgery, statistically significant decrease with respect to preoperative values was recorded for all the parameters studied: proteins (P < 0.001), albumin (P < 0.001), prealbumin (P < 0.01), transferrin (P < 0.001), and lymphocytes (P < 0.001). CONCLUSION: Our results showed a significant postoperative decrease in the nutritional parameters analyzed in a previously well-nourished population considered to be at low risk for nutritional depletion.

[Anesthesia for scoliosis surgery: preoperative assessment and risk screening of patients undergoing surgery to correct spinal deformity]. / Anestesia para la cirugía de la escoliosis. Estudio preoperatorio y selección de pacientes de riesgo en la cirugía de las deformidades raquídeas.

Spinal column deformity is associated with potentially serious alterations of respiratory and cardiac function. Such alterations, in association with the underlying disease that caused the deformity--such as neuromuscular disease--are risk factors that affect the prognosis for scoliosis patients undergoing anesthesia and surgery. It is important for the anesthesiologist to carry out a detailed preoperative assessment to identify patients at risk with the aim of decreasing morbidity and mortality related to surgical correction of deformities. Of paramount importance is awareness of the risk of injury to the spinal cord that will affect function. Other issues are how to manage the patient in anomalous positions, the risk associated with hypothermia secondary to exposure of a large surgical field for a long period, and bleeding, which can sometimes exceed the patient's total volume. In the case of scoliosis surgery, all those situations may converge, obliging us to provide careful intraoperative monitoring, particularly of spinal function; to choose the appropriate anesthetic technique; and to maintain vigilance during the early postoperative period to foresee possible complications. Because scoliosis surgery is multidisciplinary, several teams must work together to assure success.