11 results on '"Wikkelsø AJ"'
Search Results
2. Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care: Second update 2022.
- Author
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Kietaibl S, Ahmed A, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Godier A, Haas T, Jacob M, Lancé MD, Llau JV, Meier J, Molnar Z, Mora L, Rahe-Meyer N, Samama CM, Scarlatescu E, Schlimp C, Wikkelsø AJ, and Zacharowski K
- Subjects
- Humans, Critical Care, Blood Loss, Surgical, Awareness, Consensus, Anesthesiology
- Abstract
Background: Management of peri-operative bleeding is complex and involves multiple assessment tools and strategies to ensure optimal patient care with the goal of reducing morbidity and mortality. These updated guidelines from the European Society of Anaesthesiology and Intensive Care (ESAIC) aim to provide an evidence-based set of recommendations for healthcare professionals to help ensure improved clinical management., Design: A systematic literature search from 2015 to 2021 of several electronic databases was performed without language restrictions. Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used to assess the methodological quality of the included studies and to formulate recommendations. A Delphi methodology was used to prepare a clinical practice guideline., Results: These searches identified 137 999 articles. All articles were assessed, and the existing 2017 guidelines were revised to incorporate new evidence. Sixteen recommendations derived from the systematic literature search, and four clinical guidances retained from previous ESAIC guidelines were formulated. Using the Delphi process on 253 sentences of guidance, strong consensus (>90% agreement) was achieved in 97% and consensus (75 to 90% agreement) in 3%., Discussion: Peri-operative bleeding management encompasses the patient's journey from the pre-operative state through the postoperative period. Along this journey, many features of the patient's pre-operative coagulation status, underlying comorbidities, general health and the procedures that they are undergoing need to be taken into account. Due to the many important aspects in peri-operative nontrauma bleeding management, guidance as to how best approach and treat each individual patient are key. Understanding which therapeutic approaches are most valuable at each timepoint can only enhance patient care, ensuring the best outcomes by reducing blood loss and, therefore, overall morbidity and mortality., Conclusion: All healthcare professionals involved in the management of patients at risk for surgical bleeding should be aware of the current therapeutic options and approaches that are available to them. These guidelines aim to provide specific guidance for bleeding management in a variety of clinical situations., (Copyright © 2023 European Society of Anaesthesiology and Intensive Care. Unauthorized reproduction of this article is prohibited.)
- Published
- 2023
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3. Recombinant factor VIIa in postpartum haemorrhage.
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Wikkelsø AJ and Stensballe J
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- Female, Humans, Randomized Controlled Trials as Topic, Factor VIIa therapeutic use, Postpartum Hemorrhage drug therapy, Recombinant Proteins therapeutic use
- Abstract
Recombinant factor VIIa (rFVIIa) has of April 2022 been approved by the European Medicines Agency for treatment of severe postpartum haemorrhage. The extended approval is based on one small open-label, non-blinded randomized trial of 84 women from 2015 showing reduced "second line" treatment, but also increased risk of thromboembolism. Systematic use of tranexamic acid and timely coagulation assessment with thromboelastography/rotational thromboelastometry are not applied. Danish and international societies recommend that rFVIIa is reserved as a last option in severe life-threatening cases of postpartum haemorrhage.
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- 2022
4. General or regional anaesthesia for postpartum haemorrhage-A national population-based cohort study.
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Wikkelsø AJ, Secher EL, and Edwards H
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- Cesarean Section, Cohort Studies, Female, Humans, Pregnancy, Anesthesia, Conduction, Postpartum Hemorrhage epidemiology
- Abstract
Background: Anaesthesia is required to assist the treatment of postpartum haemorrhage (PPH) when manual removal of the placenta or emptying of the uterine cavity is required. The choice between general or regional anaesthesia may depend upon factors such as existing epidural, airway, hypovolaemia, and tradition., Methods: Data from a randomized controlled trial of PPH (FIB-PPH) was used to reveal differences between delivery centres. In addition, national data of 5,601 PPH procedures requiring anaesthesia during 2010-2015 was collected from the Danish Medical Birth Registry, the National Danish Patient Registry, and the Danish Anaesthesia Database. The aim is to describe the variation in choice of anaesthesia for treatment of PPH., Results: Data from the randomized trial showed large differences in practice between centres not explained by physiological factors. Using national Danish registry data, we show that large delivery centres as compared to small centres prefer regional anaesthesia for PPH procedures in opposed to general anaesthesia. Sevoflurane was used despite it causing uterine relaxation. The use of general anaesthesia was associated with younger parturients, larger blood loss, and larger Body-Mass Index. Aspiration was recorded in one case (0.02%). In the postoperative care-unit general anaesthesia was associated with a shorter stay, but also higher pain score at admission., Conclusion: Practice varies immensely between delivery centres with large centres preferring regional anaesthesia. Difference in practice might be explained by level of experience, here large centres might be more confident using regional anaesthesia. Knowledge is being extrapolated from literature on caesarean sections. Future studies should address the optimal choice of anaesthesia for PPH procedures., (© 2021 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)
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- 2022
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5. The increasing role of a retained placenta in postpartum blood loss: a cohort study.
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Edwards HM, Svare JA, Wikkelsø AJ, Lauenborg J, and Langhoff-Roos J
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- Adult, Cohort Studies, Female, Humans, Pregnancy, Retrospective Studies, Risk Factors, Young Adult, Labor Stage, Third physiology, Placenta, Retained physiopathology, Postpartum Hemorrhage etiology
- Abstract
Purpose: To describe the association between quantity of blood loss, duration of the third stage of labour, retained placenta and other risk factors, and to describe the role of a retained placenta depending on the cutoff used to define postpartum haemorrhage., Methods: Cohort study of all vaginal deliveries at two Danish maternity units between 1 January 2009 and 31 December 2013 (n = 43,357), univariate and multivariate linear regression statistical analyses., Results: A retained placenta was shown to be a strong predictor of quantity of blood loss and duration of the third stage of labour a weak predictor of quantity of blood loss. The predictive power of the third stage of labour was further reduced in the multivariate analysis when including retained placenta in the model. There was an increase in the role of a retained placenta depending on the cutoff used to define postpartum haemorrhage, increasing from 12% in cases of blood loss ≥ 500 ml to 53% in cases of blood loss ≥ 2000 ml CONCLUSION: The predictive power of duration of the third stage of labour in regard to postpartum blood loss was diminished by the influence of a retained placenta. A retained placenta was, furthermore, present in the majority of most severe cases.
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- 2019
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6. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016.
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Kozek-Langenecker SA, Ahmed AB, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Haas T, Jacob M, Lancé MD, Pitarch JVL, Mallett S, Meier J, Molnar ZL, Rahe-Meyer N, Samama CM, Stensballe J, Van der Linden PJF, Wikkelsø AJ, Wouters P, Wyffels P, and Zacharowski K
- 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 stabilise macrocirculation and microcirculation to optimise the patient's tolerance to bleeding. Finally, targeted interventions should be used to reduce intraoperative and postoperative bleeding, and so prevent subsequent morbidity and mortality. The objective of these updated guidelines is to provide healthcare professionals with an overview of the most recent evidence to help ensure improved clinical management of patients. For this update, electronic databases were searched without language restrictions from 2011 or 2012 (depending on the search) until 2015. These searches produced 18 334 articles. All articles were assessed and the existing 2013 guidelines were revised to take account of new evidence. 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. The final draft guideline was posted on the European Society of Anaesthesiology website for four weeks for review. All comments were collated and the guidelines were amended as appropriate. This publication reflects the output of this work.
- Published
- 2017
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7. The role of fibrinogen and haemostatic assessment in postpartum haemorrhage: preparations for a randomised controlled trial.
- Author
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Wikkelsø AJ
- Subjects
- Blood Coagulation drug effects, Blood Coagulation physiology, Denmark, Female, Fibrinogen metabolism, Humans, Infant, Newborn, Postpartum Hemorrhage mortality, Pregnancy, Prognosis, Randomized Controlled Trials as Topic, Risk Assessment, Role, Severity of Illness Index, Survival Rate, Treatment Outcome, Fibrinogen administration & dosage, Hemostatics administration & dosage, Postpartum Hemorrhage drug therapy, Postpartum Hemorrhage physiopathology
- Abstract
Pregnancy is a state of hypercoagulobility that might be an evolutionary way of protecting parturients from exsanguination following child birth. Observational studies suggest an association between a low level of fibrinogen (coagulation factor I) at the start of postpartum haemorrhage (PPH) and subsequent severity of bleeding. Fibrinogen concentrate may be prescribed to correct acquired hypofibrinogenaemia, but evidence is lacking regarding the treatment efficacy. This thesis assesses the current evidence for the use of fibrinogen concentrate and haemostatic assessment in bleeding patients with special attention to the obstetrical population. It includes five papers: In Paper I the benefits or harms of fibrinogen concentrate in bleeding patients in general was evaluated using a systematic Cochrane review methodology with metaanalysis of all published randomized controlled trials (RCTs). Six trials with high risk of bias were included (248 patients). Fibrinogen appeared to reduce the need of allogenic transfusions by 53%. However, the included trials were conducted only in an elective surgical setting with a population of mainly cardiac surgical patients. Paper II was also a systematic review based on Cochrane methodology evaluating the use of viscoelastic haemostatic assays to guide haemostatic transfusion in bleeding patients. Nine RCTs (776 patients) with high risk of bias were included primarily in elective cardiac surgical patients and none were specific for the obstetric subpopulation. Viscoelastic haemostatic assay guided transfusion algorithm reduced blood loss and the proportion of patients exposed to fresh frozen plasma (FFP) or platelets. In both studies, we were unable to make firm conclusion on our primary outcome, "all cause mortality" due to lack of adequate data. Paper III was based on two national Danish registries evaluating the predictability of postpartum blood transfusion. Prediction was found difficult. However, retained placental parts seemed to be the strongest predictor. Since this diagnosis is made very late and often in association with the onset of bleeding, tools to perform an early diagnosis is highly warranted. Paper IV includes recommendations of the European Society of Anaesthesiology regarding the use of fibrinogen concentrate in PPH, and is based on very weak (GRADE 2) evidence and low confidence in estimates of effect (GRADE C). Paper V describes the protocol for a RCT of early fibrinogen supplementation in women with severe postpartum haemorrhage. Several practical, ethical and trial management challenges need to be addressed when conducting independent clinical research involving parturients with severe bleeding, placebo-controlled and blinded administration of a drug in a multicenter set-up with enrolments during the entire day and with many personnel involved.
- Published
- 2015
8. Pre-emptive treatment with fibrinogen concentrate for postpartum haemorrhage: randomized controlled trial.
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Wikkelsø AJ, Edwards HM, Afshari A, Stensballe J, Langhoff-Roos J, Albrechtsen C, Ekelund K, Hanke G, Secher EL, Sharif HF, Pedersen LM, Troelstrup A, Lauenborg J, Mitchell AU, Fuhrmann L, Svare J, Madsen MG, Bødker B, and Møller AM
- Subjects
- Double-Blind Method, Erythrocyte Transfusion, Female, Fibrinogen adverse effects, Hemostasis, Humans, Postpartum Hemorrhage blood, Pregnancy, Treatment Outcome, Fibrinogen therapeutic use, Postpartum Hemorrhage drug therapy
- Abstract
Background: In early postpartum haemorrhage (PPH), a low concentration of fibrinogen is associated with excessive subsequent bleeding and blood transfusion. We hypothesized that pre-emptive treatment with fibrinogen concentrate reduces the need for red blood cell (RBC) transfusion in patients with PPH., Methods: In this investigator-initiated, multicentre, double-blinded, parallel randomized controlled trial, we assigned subjects with severe PPH to a single dose of fibrinogen concentrate or placebo (saline). A dose of 2 g or equivalent was given to all subjects independent of body weight and the fibrinogen concentration at inclusion. The primary outcome was RBC transfusion up to 6 weeks postpartum. Secondary outcomes were total blood loss, total amount of blood transfused, occurrence of rebleeding, haemoglobin <58 g litre(-1), RBC transfusion within 4 h, 24 h, and 7 days, and as a composite outcome of 'severe PPH', defined as a decrease in haemoglobin of >40 g litre(-1), transfusion of at least 4 units of RBCs, haemostatic intervention (angiographic embolization, surgical arterial ligation, or hysterectomy), or maternal death., Results: Of the 249 randomized subjects, 123 of 124 in the fibrinogen group and 121 of 125 in the placebo group were included in the intention-to-treat analysis. At inclusion the subjects had severe PPH, with a mean blood loss of 1459 (sd 476) ml and a mean fibrinogen concentration of 4.5 (sd 1.2) g litre(-1). The intervention group received a mean dose of 26 mg kg(-1) fibrinogen concentrate, thereby significantly increasing fibrinogen concentration compared with placebo by 0.40 g litre(-1) (95% confidence interval, 0.15-0.65; P=0.002). Postpartum blood transfusion occurred in 25 (20%) of the fibrinogen group and 26 (22%) of the placebo group (relative risk, 0.95; 95% confidence interval, 0.58-1.54; P=0.88). We found no difference in any predefined secondary outcomes, per-protocol analyses, or adjusted analyses. No thromboembolic events were detected., Conclusions: We found no evidence for the use of 2 g fibrinogen concentrate as pre-emptive treatment for severe PPH in patients with normofibrinogenaemia., Clinical Trial Registration: ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01359878. Published protocol: http://www.trialsjournal.com/content/pdf/1745-6215-13-110.pdf., (© The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
- Published
- 2015
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9. Prediction of postpartum blood transfusion--risk factors and recurrence.
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Wikkelsø AJ, Hjortøe S, Gerds TA, Møller AM, and Langhoff-Roos J
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- Cohort Studies, Denmark epidemiology, Female, Forecasting, Humans, Parity, Placenta, Retained epidemiology, Postpartum Hemorrhage epidemiology, Postpartum Hemorrhage etiology, Pregnancy, Risk Factors, Blood Transfusion statistics & numerical data, Postpartum Hemorrhage therapy, Registries
- Abstract
Objective: The aim was to find clinically useful risk factors for postpartum transfusion and to assess the joint predictive value in a population of women with a first and second delivery., Methods: All Danish women with a first and second delivery from January 2001 to September 2009 who gave birth in a hospital that reported transfusion of red blood cells to a national database: A total of 96 545 women were included., Results: Retained placental tissue explained more than all other risk factors in vaginal deliveries. Retained placental tissue at first delivery was associated with postpartum transfusion at a second vaginal delivery, and may also be used as an early predictor in parallel with a history of either placental abruption, postpartum transfusion or caesarean delivery. The positive predictive values of having more than one risk factor was low (2.2%-2.7%)., Conclusions: Prediction of postpartum transfusion is difficult. Retained placental tissue is the strongest predictor of postpartum blood transfusion in vaginal deliveries. Retained placental tissue is usually diagnosed for the first time when the bleeding starts, which limits the clinical value of prediction. We need tools for an early diagnosis of retained placenta to intervene early before transfusion is needed.
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- 2014
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10. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology.
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Kozek-Langenecker SA, Afshari A, Albaladejo P, Santullano CA, De Robertis E, Filipescu DC, Fries D, Görlinger K, Haas T, Imberger G, Jacob M, Lancé M, Llau J, Mallett S, Meier J, Rahe-Meyer N, Samama CM, Smith A, Solomon C, Van der Linden P, Wikkelsø AJ, Wouters P, and Wyffels P
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- Advisory Committees, Anesthesiology methods, Disease Management, Europe, Humans, Meta-Analysis as Topic, Preoperative Care methods, Randomized Controlled Trials as Topic methods, Randomized Controlled Trials as Topic standards, Research Report standards, Anesthesiology standards, Blood Loss, Surgical prevention & control, Practice Guidelines as Topic standards, Preoperative Care standards, Severity of Illness Index, Societies, Medical standards
- 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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- 2013
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11. [Hyperfibrinolysis as the cause of haemorrhage and increased mortality in trauma patients].
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Wikkelsø AJ, Afshari A, Stensballe J, and Johansson PI
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- Antifibrinolytic Agents therapeutic use, Blood Transfusion, Hemorrhage etiology, Hemorrhage mortality, Humans, Shock, Hemorrhagic blood, Shock, Hemorrhagic mortality, Thrombelastography, Tranexamic Acid therapeutic use, Wounds and Injuries mortality, Blood Coagulation Disorders complications, Blood Coagulation Disorders diagnosis, Blood Coagulation Disorders drug therapy, Fibrinolysis, Hemorrhage blood, Wounds and Injuries blood
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Trauma-associated coagulopathies are at times present upon arrival at the emergency department. Hyperfibrinolysis is a condition in which the natural ability to dissolve blood clots is pathologically enhanced. It is present in 2-8% of trauma patients and associated with shock and increased mortality. Hyperfibrinolysis is easily detected by thromboelastography. The condition is treated with antifibrinolytics such as tranexamic acid--whereas transfusion with blood products is inefficient. This article explores the mechanisms and diagnostics of hyperfibrinolysis in trauma patients and the relevant treatment options.
- Published
- 2011
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