Management of severe perioperative bleeding Guidelines from the European Society of Anaesthesiology
University of Copenhagen1, Centre Hospitalier Universitaire de Grenoble2, University of Valladolid3, University of Naples Federico II4, Innsbruck Medical University5, Ludwig Maximilian University of Munich6, Maastricht University7, University of Valencia8, Royal Lancaster Infirmary9, University of Salzburg10
01 Jun 2013-European Journal of Anaesthesiology (Lippincott Williams & Wilkins)-Vol. 30, Iss: 6, pp 270-382
TL;DR: These guidelines are intended to provide an overview of current knowledge on the subject with an assessment of the quality of the evidence in order to allow anaesthetists throughout Europe to integrate this knowledge into daily patient care wherever possible.
Abstract: The aims of severe perioperative bleeding management are three-fold. First, preoperative identification by anamesis and laboratory testing of those patients for whom the perioperative bleeding risk may be increased. Second, implementation of strategies for correcting preoperative anaemia and stabilisation of the macro- and microcirculations in order to optimise the patient’s tolerance to bleeding. Third, targeted procoagulant interventions to reduce the amount of bleeding, morbidity, mortality and costs. The purpose of these guidelines is to provide an overview of current knowledge on the subject with an assessment of the quality of the evidence in order to allow anaesthetists throughout Europe to integrate this knowledge into daily patient care wherever possible. The Guidelines Committee of the European Society of Anaesthesiology (ESA) formed a task force with members of scientific subcommittees and individual expert members of the ESA. Electronic databases were searched without language restrictions from the year 2000 until 2012. These searches produced 20 664 abstracts. Relevant systematic reviews with meta-analyses, randomised controlled trials, cohort studies, case-control studies and cross-sectional surveys were selected. At the suggestion of the ESA Guideline Committee, the Scottish Intercollegiate Guidelines Network (SIGN) grading system was initially used to assess the level of evidence and to grade recommendations. During the process of guideline development, the official position of the ESA changed to favour the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. This report includes general recommendations as well as specific recommendations in various fields of surgical interventions. The final draft guideline was posted on the ESA website for four weeks and the link was sent to all ESA members. Comments were collated and the guidelines amended as appropriate. When the final draft was complete, the Guidelines Committee and ESA Board ratified the guidelines.
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TL;DR: The guideline now recommends that patients be transferred directly to an appropriate trauma treatment centre and encourages use of a restricted volume replacement strategy during initial resuscitation, and may also serve as a basis for local implementation.
Abstract: Severe trauma continues to represent a global public health issue and mortality and morbidity in trauma patients remains substantial. A number of initiatives have aimed to provide guidance on the management of trauma patients. This document focuses on the management of major bleeding and coagulopathy following trauma and encourages adaptation of the guiding principles to each local situation and implementation within each institution. The pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004 and included representatives of six relevant European professional societies. The group used a structured, evidence-based consensus approach to address scientific queries that served as the basis for each recommendation and supporting rationale. Expert opinion and current clinical practice were also considered, particularly in areas in which randomised clinical trials have not or cannot be performed. Existing recommendations were reconsidered and revised based on new scientific evidence and observed shifts in clinical practice; new recommendations were formulated to reflect current clinical concerns and areas in which new research data have been generated. This guideline represents the fourth edition of a document first published in 2007 and updated in 2010 and 2013. The guideline now recommends that patients be transferred directly to an appropriate trauma treatment centre and encourages use of a restricted volume replacement strategy during initial resuscitation. Best-practice use of blood products during further resuscitation continues to evolve and should be guided by a goal-directed strategy. The identification and management of patients pre-treated with anticoagulant agents continues to pose a real challenge, despite accumulating experience and awareness. The present guideline should be viewed as an educational aid to improve and standardise the care of the bleeding trauma patients across Europe and beyond. This document may also serve as a basis for local implementation. Furthermore, local quality and safety management systems need to be established to specifically assess key measures of bleeding control and outcome. A multidisciplinary approach and adherence to evidence-based guidance are key to improving patient outcomes. The implementation of locally adapted treatment algorithms should strive to achieve measureable improvements in patient outcome.
1,247 citations
Cites background from "Management of severe perioperative ..."
...However, there are still no adequately powered prospective clinical trials to demonstrate the risk:benefit of using a source of additional fibrinogen to manage bleeding trauma patients [424, 425]....
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TL;DR: This update includes revisions to existing recommendations with respect to the wording, or changes in the grade of recommendation, and also the addition of new recommendations.
Abstract: The management of perioperative bleeding involves multiple assessments and strategies to ensure appropriate patient care. Initially, it is important to identify those patients with an increased risk of perioperative bleeding. Next, strategies should be employed to correct preoperative anaemia and to
613 citations
01 Dec 2014
TL;DR: A welcome decrease in the overall rate of maternal death across the United Kingdom is shown, and a compelling message for the future has to be the importance of continuing the programme of vaccination against influenza in pregnancy in the UK and Ireland, working to maximise uptake and hence to ensure the authors prevent future influenza-related maternal deaths.
Abstract: This report continues the longest running programme of Confidential Enquiries into maternal deaths worldwide, and shows a welcome decrease in the overall rate of maternal death across the United Kingdom. In addition, it includes, for the first time, Confidential Enquiries into maternal deaths occurring in Ireland. The importance of this report lies in going “beyond the numbers” and recognising the death of every woman during or after pregnancy as a tragedy from which it is incumbent upon us, as health professionals, service planners or policymakers to learn lessons to improve future care. We must recognise that each woman included in this report leaves behind a bereaved family on whom the impact of her death will be lifelong. We owe it to those left behind to learn from the death of their mother, partner, daughter or friend and to make changes for the future to prevent other women from dying. The focus of this report is therefore clearly to the future, on the actions, small and large, that we as a community or an individual can make to continue to improve the quality of maternity care across the UK and Ireland. As such, it is also enhanced by the inclusion, for the first time, of Confidential Enquiries into the care of women with severe complications in pregnancy, but who survived, thus broadening the messages to improve care yet further. As always, the focus is not in attributing blame, but on improving future mothers’ care. Maternal deaths from genital tract sepsis have fallen significantly, but as this report shows, infections from all causes are an important cause of maternal death. This report spans the period of the influenza A/H1N1 pandemic, which severely affected pregnant women in particular. Some women died before immunisation was introduced, but a number of unvaccinated women died after the vaccination programme began, and, more recently, some women died from non-pandemic type seasonal influenza. The compelling message for the future has to be the importance of continuing the programme of vaccination against influenza in pregnancy in the UK and Ireland, working to maximise uptake and hence to ensure we prevent future influenza-related maternal deaths. At the same time, and as highlighted across many areas of the health service, early identification of pregnant and postpartum women whose medical condition is deteriorating and rapid actions to diagnose and treat pregnant and postpartum women with suspected sepsis will save lives. The importance of routine measurements such as pulse, temperature, respiratory rate and blood pressure in any ill pregnant women cannot be over-emphasised. Pregnant women can appear relatively well and yet become seriously ill with sepsis very quickly. Midwives, doctors and other health professionals need to “think sepsis” and implement sepsis bundles, including giving antibiotics within an hour of the diagnosis being suspected. The consistent year on year decrease in direct maternal deaths is evidence of commitment to and success in improving the care of women with obstetric complications in pregnancy throughout the health service. However, we still need to plan for the care of women with known co-existing medical complications in pregnancy. The majority of women who die during or after pregnancy in the UK and Ireland die from indirect causes, that is, from an exacerbation of their pre-existing diseases. Commitment to improve care for these women is needed across all professional organisations and groups, working alongside researchers to provide the evidence to ensure that we can provide the best care for women pre-pregnancy, during and after pregnancy. Throughout the report, areas of guidance where care can be improved have been clearly highlighted; an obvious area in which specific guidance is lacking is for the care of women with epilepsy in pregnancy. As Chief Medical and Nursing Officers we are committed to ensuring the development of such guidance and hence optimal care for mothers with epilepsy. This report would not be possible without the dedication and commitment of health professionals throughout the UK and Ireland. In particular, we would like to thank the dedicated assessors who review each individual woman’s death in order to identify actions to improve care in the future. This work is carried out without remuneration and in the assessors own time, because of their commitment to continuous quality improvement. It behoves health service provider organisations including hospitals, health boards, executives and trusts to continue to recognise the importance of this work at both a national and local level and allow assessors dedicated time for it to continue. We therefore welcome the findings in the report that will ultimately help improve outcomes for mothers and their families across the UK and Ireland.
595 citations
University of Málaga1, National Institute for Health Research2, University of Washington3, Cambridge University Hospitals NHS Foundation Trust4, Copenhagen University Hospital5, Gulf Coast Regional Blood Center6, University of Angers7, The Royal Marsden NHS Foundation Trust8, University College London9, Papworth Hospital10
TL;DR: A diagnostic approach for anaemia and iron deficiency in surgical patients; identification of patients appropriate for treatment; and advice on practical management and follow‐up are developed.
Abstract: Despite current recommendations on the management of pre-operative anaemia, there is no pragmatic guidance for the diagnosis and management of anaemia and iron deficiency in surgical patients. A number of experienced researchers and clinicians took part in an expert workshop and developed the following consensus statement. After presentation of our own research data and local policies and procedures, appropriate relevant literature was reviewed and discussed. We developed a series of best-practice and evidence-based statements to advise on patient care with respect to anaemia and iron deficiency in the peri-operative period. These statements include: a diagnostic approach for anaemia and iron deficiency in surgical patients; identification of patients appropriate for treatment; and advice on practical management and follow-up. We urge anaesthetists and peri-operative physicians to embrace these recommendations, and hospital administrators to enable implementation of these concepts by allocating adequate resources.
528 citations
Cites background from "Management of severe perioperative ..."
...Recently, the National Institute for Clinical Excellence [69] and other international guidelines [4, 5, 70] have reduced the transfusion thresholds for surgical patients to 70 g....
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TL;DR: The term acute liver failure (ALF) is frequently applied as a generic expression to describe patients presenting with or developing an acute episode of liver dysfunction, however, it refers to a highly specific and rare syndrome, characterised by an acute abnormality of liver blood tests in an individual without underlying chronic liver disease.
522 citations
References
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TL;DR: In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage.
Abstract: Background Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. Methods In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran — 110 mg or 150 mg twice daily — or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. Results Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P = 0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P = 0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P = 0.13) and 3.64% per year with 150 mg of dabigatran (P = 0.051). Conclusions In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.)
9,676 citations
TL;DR: In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism and there was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivroxaban group.
Abstract: Methods In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. Results In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P = 0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P = 0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P = 0.02) and fatal bleeding (0.2% vs. 0.5%, P = 0.003) in the rivaroxaban group. Conclusions In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.)
7,716 citations
Duke University1, Boston University2, Bristol-Myers Squibb3, Lenox Hill Hospital4, Oslo University Hospital5, University of California, San Francisco6, University of Alberta7, University of Missouri8, University of New Mexico9, Mayo Clinic10, Tokai University11, Goethe University Frankfurt12, University of Adelaide13, Charles University in Prague14, Autonomous University of Madrid15, St. John's Medical College16, Uppsala University17
TL;DR: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.
Abstract: A b s t r ac t Background Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. Methods In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic em - bolism. The trial was designed to test for noninferiority, with key secondary objec - tives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. Results The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the war - farin group (hazard ratio with apixaban, 0.79; 95% confidence interval (CI), 0.66 to 0.95; P<0.001 for noninferiority; P = 0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P = 0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ra - tio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P = 0.42). Conclusions In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.)
7,154 citations
TL;DR: This document summarizes current research, plans, and recommendations for future research, as well as providing a history of the field and some of the techniques used, currently in use, at the National Institutes of Health.
Abstract: Jeffrey L. Anderson, MD, FACC, FAHA, Chair
Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect
Nancy M. Albert, PhD, RN, FAHA
Biykem Bozkurt, MD, PhD, FACC, FAHA
Ralph G. Brindis, MD, MPH, MACC
Mark A. Creager, MD, FACC, FAHA[#][1]
Lesley H. Curtis, PhD, FAHA
David DeMets, PhD[#][1]
Robert A
6,967 citations
TL;DR: In patients with acute coronary syndromes with scheduled percutaneous coronary intervention, prasugrel therapy was associated with significantly reduced rates of ischemic events, including stent thrombosis, but with an increased risk of major bleeding, including fatal bleeding.
Abstract: The primary efficacy end point occurred in 12.1% of patients receiving clopidogrel and 9.9% of patients receiving prasugrel (hazard ratio for prasugrel vs. clopidogrel, 0.81; 95% confidence interval [CI], 0.73 to 0.90; P<0.001). We also found significant reductions in the prasugrel group in the rates of myocardial infarction (9.7% for clopidogrel vs. 7.4% for prasugrel; P<0.001), urgent target-vessel revascularization (3.7% vs. 2.5%; P<0.001), and stent thrombosis (2.4% vs. 1.1%; P<0.001). Major bleeding was observed in 2.4% of patients receiving prasugrel and in 1.8% of patients receiving clopidogrel (hazard ratio, 1.32; 95% CI, 1.03 to 1.68; P = 0.03). Also greater in the prasugrel group was the rate of life-threatening bleeding (1.4% vs. 0.9%; P = 0.01), including nonfatal bleeding (1.1% vs. 0.9%; hazard ratio, 1.25; P = 0.23) and fatal bleeding (0.4% vs. 0.1%; P = 0.002). Conclusions In patients with acute coronary syndromes with scheduled percutaneous coronary intervention, prasugrel therapy was associated with significantly reduced rates of ischemic events, including stent thrombosis, but with an increased risk of major bleeding, including fatal bleeding. Overall mortality did not differ significantly between treatment groups. (ClinicalTrials.gov number, NCT00097591.)
6,021 citations