BACKGROUND:The AdFIrst phase 3 trial evaluated the efficacy and safety of human fibrinogen concentrate (FC) versus standard of care for major bleeding in complex surgery. This subanalysis evaluated a preemptive hemostatic strategy using FC versus cryoprecipitate (Cryo) to manage severe bleeding patients undergoing major abdominal surgery, specifically cytoreductive surgery (CRS) for pseudomyxoma peritonei (PMP). METHODS:A single-center UK analysis derived from a randomized, active-controlled, partially blinded, phase 3, non-inferiority trial. Patients undergoing PMP surgery with predicted intraoperative blood loss >2 L were randomized (1:1) to receive either FC (4 g) or two pools of Cryo (10 units) with repeat dosing as required. The primary endpoint was intraoperative blood loss, measured from the decision to treat the patient with trial drug until the end of surgery with a non-inferiority margin of 150 mL (ClinicalTrials.gov: NCT03444324). RESULTS:Between March 2021 and September 2023, 98 patients (48 FC; 50 Cryo) were enrolled, randomized, and evaluated. The primary endpoint was met: Least squares mean intraoperative blood loss was 1517 mL (95% CI, 1331-1703) with FC and 1706 mL (95% CI, 1524-1889) with Cryo, corresponding to a difference of -190 mL (95% CI, -450 to 71; nominal exploratory p = 0.011). The upper bound of the 95% CI was below the prespecified non-inferiority margin, consistent with the non-inferiority observed in the overall trial. Thromboembolic events occurred in fewer patients in the FC group (3 [6.3%]) than in the Cryo group (11 [22%]; nominal exploratory p = 0.041); other safety outcomes were comparable between groups. CONCLUSION:In patients undergoing CRS for PMP, these results provide supportive evidence for the hemostatic efficacy of FC, consistent with the overall trial and prior studies, with a favorable safety profile. In this single-center PMP subgroup, the findings support a preemptive fibrinogen strategy that may inform practice in other surgical settings and warrants evaluation in future studies.
Laienreanimationsunterricht soll als Teil der schulischen Bildung dazu beitragen, Laienreanimationsquoten zu erhöhen und damit das Überleben nach einem Kreislaufstillstand zu verbessern. Die Umsetzung ist in Deutschland heterogen. In Nordrhein-Westfalen (NRW) fördert das Ministerium für Schule und Bildung seit 2017 fakultativ engagierte Schulen bei der Umsetzung. Diese Studie untersucht die aktuelle Umsetzung in NRW – im Hinblick auf Nutzung, didaktische Umsetzung und Förderpotenziale. Sekundäres Ziel war es, Einflussfaktoren auf Nutzung und Selbstverpflichtung zu analysieren. Mit dem Online-Tool EvaSys wurden über die Bezirksregierungen alle teilnehmenden Schulen in NRW von November 2023 bis März 2024 befragt. Der Fragebogen hat per Single- oder Multiplechoice-Items Nutzungsfrequenz (1 = weniger als 2 Tage; 5 = mehr als 14 Tage) und Zufriedenheit (1 = gar nicht; 5 = sehr) mit der zur Verfügung gestellten PractiMan-Puppe, die didaktische und organisatorische Gestaltung und die Bedarfe an Medien und Ausstattung bzw. an Maßnahmen erhoben. Von 371 befragten Schulen haben 128 (34,5
Fibrinogen is an essential component of hemostasis and clot formation that stabilizes the platelet-dependent primary hemostatic process. Low fibrinogen levels can be primary (congenital) or secondary (acquired). Acquired hypofibrinogenemia may result from chronic diseases (e.g., liver, autoimmune diseases, and malignancies) or major hemorrhage (e.g., trauma, surgery). Low fibrinogen levels are both a symptom and a precipitating factor for coagulopathy and ongoing bleeding. Fibrinogen repletion with fibrinogen-containing products is important for managing coagulopathic bleeding with suspected or documented hypofibrinogenemia. Different available fibrinogen sources include fibrinogen concentrate, cryoprecipitate, and frozen plasma and vary based on multiple factors including fibrinogen content, purity, other clotting or non-clotting proteins (e.g., immunomodulating proteins or proteins of unknown function), preparation time, safety, volumes, and availability. Fibrinogen replacement strategies have been studied in trauma but also in patients undergoing spine, cytoreductive, and cardiac surgery. In this review, we discuss the physiological actions of fibrinogen, strategies for control of coagulopathic bleeding related to hypofibrinogenemia, and the therapeutic, logistical, and economic factors that influence treatment decisions. In addition, current guidelines and clinical studies were considered regarding the formation of evidence-based treatment strategies that can be individualized at the patient’s bedside.
Background:Major haemorrhage is associated with considerable morbidity and mortality, but the optimal treatment remains disputed. This trial aimed to compare the efficacy and safety of human fibrinogen concentrate (FC) vs. either fresh frozen plasma (FFP) or cryoprecipitate (Cryo) as first-line treatment in patients with major bleeding during major orthopaedic or abdominal surgery, respectively. Methods:AdFIrst was a randomised, active-controlled, partially blinded, non-inferiority phase 3 trial conducted at 15 hospitals in Europe. Eligible patients (≥18 years), undergoing major spinal surgery or cytoreductive surgery for pseudomyxoma peritonei, with clinically relevant intraoperative blood loss were randomised by an interactive web response system (1:1) to receive intravenous FC (2-4 g) compared to FFP (15 mL/kg body weight) or Cryo (10 units); doses were repeated as needed. The primary endpoint was intraoperative blood loss from the time of decision to treat until the end of surgery with a non-inferiority margin of 150 mL, assessed in the per-protocol analysis set (PPS). Safety was assessed in all patients who received at least one dose of trial drug. The trial is complete (ClinicalTrials.gov: NCT03444324). Findings:Between February 12, 2018, and November 21, 2023, 222 patients (131 [59%] female; 91 [41%] male; 97% white) were enrolled and randomly assigned to receive either FC (n = 110) or FFP/Cryo (n = 112). The PPS included 201 patients (FC: n = 103; FFP/Cryo: n = 98). The primary endpoint was met; the least squares mean (LSM: adjusted mean estimated using ANOVA) intraoperative blood loss was 1381 mL (95% confidence interval [CI] 1187-1574) in the FC group and 1660 mL (95% CI 1461-1860) in the FFP/Cryo group. The LSM difference was -279 mL (95% CI -552 to -6; p < 0·0001), indicating a notable treatment difference beyond non-inferiority. In a post-hoc analysis, FC showed superiority to reduce intraoperative blood loss over FFP/Cryo in the PPS (p = 0·0087). Serious adverse events were reported in 28/110 patients (25%) in the FC and 41/112 patients (37%) in the FFP/Cryo group. Thromboembolic events occurred in 17 patients (FC: 4 (4%) and FFP/Cryo: 13 (12%). There were no treatment-related deaths. Interpretation:In patients undergoing major spinal or cytoreductive surgery for pseudomyxoma peritonei (PMP), FC was non-inferior to FFP/Cryo for the management of clinically relevant intraoperative bleeding. The efficacy and safety advantages observed in this trial support the emerging adoption of first-line use of FC in treatment guidelines. Funding:Biotest AG, Germany.
Fibrinogen concentrate treatment is recommended for acute bleeding episodes in adult and pediatric patients with congenital and acquired fibrinogen deficiency. Previous studies have reported a low risk of thromboembolic events (TEEs) with fibrinogen concentrate use; however, the post-treatment TEE risk remains a concern. A retrospective evaluation of RiaSTAP ® /Haemocomplettan ® P (CSL Behring, Marburg, Germany) post-marketing data was performed (January 1986–June 2022), complemented by a literature review of published studies. Approximately 7.45 million grams of fibrinogen concentrate was administered during the review period. Adverse drug reactions (ADRs) were reported in 337 patients, and 81 (24.0%) of these patients experienced possible TEEs, including 14/81 (17.3%) who experienced fatal outcomes. Risk factors and the administration of other coagulation products existed in most cases, providing alternative explanations. The literature review identified 52 high-ranking studies with fibrinogen concentrate across various clinical areas, including 26 randomized controlled trials. Overall, a higher number of comparative studies showed lower rates of ADRs and/or TEEs in the fibrinogen group versus the comparison group(s) compared with those that reported higher rates or no differences between groups. Post-marketing data and clinical studies demonstrate a low rate of ADRs, including TEEs, with fibrinogen concentrate treatment. These findings suggest a favorable safety profile of fibrinogen concentrate, placing it among the first-line treatments effective for managing intraoperative hemostatic bleeding. Keywords fibrinogen concentrate , safety , post-marketing , adverse drug reaction
Background & Objectives: Cardiopulmonary resuscitation (CPR) is the key for surviving cardiac arrest. Recent recommendations propose that CPR can - and should -be taught to schoolchildren. This e-learning-based study analyzes whether face-to-face CPR training can be partly substituted with e-learning by measuring CPR knowledge and self-efficacy in trainees. Methods: In this cluster randomized-controlled prospective, students attending grades 5 to 7 of a German secondary school volunteered to participate and were randomly assigned to one of two groups with different methods for CPR training each: a traditional instructor-led group (control) where students received face-to-face teaching by a BLS instructor (45 min), and an e-learning group (intervention) where schoolchildren were able to accomplish their theoretical CPR training using an e-learning module (15 min). CPR knowledge and self-efficacy were measured and compared before (t0) and after (t1) the training using questionnaires. Face-to-face CPR training (45 min) on manikins proceeded in both groups hereafter. The formal hypothesis was that e-learning would result in better CPR knowledge. Results: Overall, 375 students participated; 33 of which had to be excluded. 342 participants were included in statistical analysis (instructor-led group n = 109; e-learning group n = 233). The study was terminated early due to the Covid19 pandemic, and did not reach the required number of participants. Lacking statistical power, an analysis of the existing datasets failed to show superiority of e-learning vs. conventional training for CPR knowledge (p = 0.306). Both groups improved CPR knowledge (p < 0.001) and self-efficacy (p < 0.001) after CPR training and showed an equal, high level of satisfaction with their perceived training method (face-to-face: 4.1[4.0-4.2] vs. e-learning: 4.0[3.9-4.1]; p = 0.153; maximum 5 points). Conclusions: This study failed to demonstrate superiority for e-learning but was terminated early and hence underpowered. Further research is necessary to prove the efficiency of e-learning tools for CPR.
This qualitative study aims to analyse the personal qualification, attitudes and the pedagogical concepts of German teachers as experts in their profession regarding basic life support (BLS) education in secondary schools. Thirteen (n = 13) secondary school teachers participated in semi-structured expert interviews and were interviewed for at least 20 to 60 min regarding BLS student education. Interviews were semi-structured with guiding questions addressing (1) personal experience, (2) teacher qualification for BLS and (3) implementation factors (e.g., personal, material and organisational). Audio-recorded interviews were analysed by content analysis, generating a coding system. School teachers provided a heterogeneous view on implementation-related processes in BLS education. Many teachers were educated in first aid, acknowledge its importance, but had no experience in teaching BLS. They want to assure being competent for teaching BLS and need tailored trainings, materials, pedagogical information and the incorporation into the curriculum. Also, the management of time constraints, unwilling colleagues, or young students being overwhelmed were commonly mentioned considerations. Concluding, teachers reported to be willing to teach BLS but a stepwise implementation framework incorporating practice-oriented qualification and educational goals is missing.
Fibrinogen concentrate treatment is recommended for acute bleeding episodes in adult and pediatric patients with congenital and acquired fibrinogen deficiency. Previous studies have reported a low risk of thromboembolic events (TEEs) with fibrinogen concentrate use; however, the post-treatment TEE risk remains a concern. A retrospective evaluation of RiaSTAP®/Haemocomplettan® P (CSL Behring, Marburg, Germany) post-marketing data was performed (January 1986–June 2022), complemented by a literature review of published studies. Approximately 7.45 million grams of fibrinogen concentrate was administered during the review period. Adverse drug reactions (ADRs) were reported in 337 patients, and 81 (24.0%) of these patients experienced possible TEEs, including 14/81 (17.3%) who experienced fatal outcomes. Risk factors and the administration of other coagulation products existed in most cases, providing alternative explanations. The literature review identified 52 high-ranking studies with fibrinogen concentrate across various clinical areas, including 26 randomized controlled trials. Overall, a higher number of comparative studies showed lower rates of ADRs and/or TEEs in the fibrinogen group versus the comparison group(s) compared with those that reported higher rates or no differences between groups. Post-marketing data and clinical studies demonstrate a low rate of ADRs, including TEEs, with fibrinogen concentrate treatment. These findings suggest a favorable safety profile of fibrinogen concentrate, placing it among the first-line treatments effective for managing intraoperative hemostatic bleeding.
BACKGROUNDManagement 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.DESIGNA 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.RESULTSThese 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%.DISCUSSIONPeri-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.CONCLUSIONAll 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.
Massive diffuse bleeding is still a problem in cardiovascular surgery. The first line treatment is platelet concentrate transfusion, although there is still insufficient information regarding efficacy, quantity, and timing. The objective of this prospective cohort study was to find out whether the amount of 4 apheresis platelet concentrates could reduce intraoperative bleeding and improve viscoelasticity and aggregometry. 10 patients were enrolled intraoperatively because of life-threatening diffuse bleeding after cardiopulmonary bypass and received 4 apheresis platelet concentrates back-to-back. The units were given every 5 minutes. After every unit, thromboelastometry, performed by ROTEM®, and aggregometry, performed by Multiplate®, were done together with Hematocrit, Hemoglobin, and Platelet Count. Hematocrit and Hemoglobin showed a statistically significant decrease of 14%, whereas Platelet Count showed a statistically significant increase of 205%. MCE-EXTEM increased statistically significant: 46%. There was no statistically significant increase in both ADP and COL results. Even a series of 4 platelet concentrates did not comprehensively improve both essential components of an adequate hemostasis: viscoelasticity and aggregation. Just the transfusion of platelet concentrates alone did not build a sufficient strategy improving hemostasis and reducing bleeding. A positive effect of surgical packing on stopping the bleeding could be seen.
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.
Haemorrhage during and following surgery results in increased morbidity and mortality. Low plasma fibrinogen levels have been associated with increased blood loss and transfusion requirements. Fibrinogen supplementation has been shown to reduce bleeding in coagulopathic patients. This post hoc study evaluated fibrinogen repletion and pharmacokinetic data from the REPLACE study. One hundred and fifty-two adult patients undergoing elective aortic surgery requiring cardiopulmonary bypass (CPB) with defined bleeding of 60-250 g at first 5 min bleeding mass were included in the phase III trial. Patients were randomized to receive either fibrinogen concentrate (FCH) or placebo following CPB removal. Plasma fibrinogen levels and viscoelastic testing parameters (ROTEM-based FIBTEM and EXTEM assays) were measured before, during, and after study treatment administration. A mean dose of 6.3 g FCH was administered in the FCH group, with a median infusion duration of 2 min. Immediately following completion of FCH administration, a rapid increase in plasma fibrinogen levels to near baseline (median change from baseline -0.10 g/l) was seen in the FCH group but not in the placebo group (median change from baseline -1.29 g/l). FCH administration also caused an immediate increase in FIBTEM maximum clot firmness (MCF) to 23 mm and improvements in EXTEM coagulation time and clot formation time by the end of infusion. There was a strong correlation between the plasma fibrinogen level and FIBTEM MCF. Treatment with high doses of FCH with a rapid infusion time resulted in immediate recovery to baseline levels of plasma fibrinogen and viscoelastic testing parameters.
Schulen stehen im Fokus als eine geeignete Institution, um Erste-Hilfe-Wissen zur Laienreanimation, zur Gesundheit und zur Prävention zu unterrichten und so sukzessive in der Gesellschaft zu etablieren. Die Implementierung einer solchen Thematik wurde in den letzten Jahren intensiv diskutiert und empfohlen. Dieser Beitrag ist darauf ausgerichtet, eine unterrichtspraktische Möglichkeit aufzuzeigen, wie der Lernabschluss von Reanimations- sowie Gesundheitsunterricht im schulischen Biologie- bzw. Sportunterricht gestaltet werden könnte. Dabei wird eine alternative Überprüfungsform, eine „Lebensretterolympiade“, genutzt. Mit der Konzeption der Lebensretterolympiade sollen zwei Bereiche verbunden werden: Es sollen Handlungskompetenz und Sicherheit im Umgang mit Notfallsituationen und zudem mit Blick auf das Thema der eigenen Herz-Kreislauf-Gesundheit gefordert und gefördert werden. Spielerisch und dennoch in realitätsnahen Szenarien und Aufgaben überprüfen die Schüler*innen ihr Wissen und ihre Handlungsfähigkeit. Wie funktioniert und adaptiert sich das menschliche Herz-Kreislauf-System? Worauf kommt es bei der Wiederbelebung an und wie arbeite ich im Team? Wie erkenne ich akute Kreislaufstörungen und wie reagiere ich darauf? Diese im vorhergehenden Unterricht thematisierten Fragen greift die Olympiade beispielhaft auf und ist daher auch anschlussfähig an Inhalte und Kompetenzziele von Lehrplänen etwa in Sport und Biologie. Der Beitrag ordnet das Material in einen didaktisch-empirischen Kontext ein und präsentiert die Unterrichtsmaterialien zusammen mit Hinweisen für die Nutzung durch Lehrkräfte.
Besides first aid courses, the introduction and implementation of basic life support (BLS) educational approaches in secondary schools has been highly recommended in the past few years (Böttiger et al., 2017;Cave et al., 2011).These public health initiatives aim to achieve a substantial contribution to the improvement of general bystander cardiopulmonary resuscitation (CPR) rates and reduce the anxiety and inhibitions of teenagers to begin CPR (Böttiger et al., 2017).Background: CPR training is recommended for secondary school students in many countries to improve bystander resuscitation and survival rates after cardiac arrest.The recommended age for implementing first aid interventions varies between studies. Methods:This study aims to examine psychological (self-efficacy, interest; primary endpoint) and physical (compression depth, rate and chest recoil) outcomes (secondary endpoint) in different age groups after a CPR intervention.A sample of 552 secondary school students from five different schools in North Rhine-Westphalia, Germany, was assigned to face-to-face CPR lessons held by student teachers.Participants were separated into two age groups (11-13 and 14-17 years), according to recommendations and previous evidence about appropriate training age.Time-and between-groupeffects were analyzed using t-tests between baseline and the final testing point.Results: A total of 365 questionnaires and 189 manikin recordings formed the complete dataset.No differences were found between age groups for self-efficacy, outcome expectancies and interest (p > 0.05).In both groups, self-efficacy and positive outcome expectancies improved, but negative expectancies as well as the students' interest did not.After the intervention, only the older students achieved a higher accuracy (80% vs. 60%; p < 0.05) and mean depth (62.6 vs. 53.9mm; p < 0.05) in chest compressions but exceeding the 50-60 mm guideline.For rate and chest recoil, no significant differences were found (p > 0.05). Conclusion:Regardless of age, all students benefit from this intervention regarding an improvement in self-efficacy and chest compressions.Negative consequences and inadequate compression rates are relatively stable within this age range and should be clearly addressed in lessons.
Schulen stehen im Fokus als eine geeignete Institution, um Erste-Hilfe-Wissen zur Laienreanimation, zur Gesundheit und zur Pravention zu unterrichten und so sukzessive in der Gesellschaft zu etablieren. Die Implementierung einer solchen Thematik wurde in den letzten Jahren intensiv diskutiert und empfohlen. Dieser Beitrag ist darauf ausgerichtet, eine unterrichtspraktische Moglichkeit aufzuzeigen, wie der Lernabschluss von Reanimations- sowie Gesundheitsunterricht im schulischen Biologie- bzw. Sportunterricht gestaltet werden konnte. Dabei wird eine alternative Uberprufungsform, eine „Lebensretterolympiade“, genutzt. Mit der Konzeption der Lebensretterolympiade sollen zwei Bereiche verbunden werden: Es sollen Handlungskompetenz und Sicherheit im Umgang mit Notfallsituationen und zudem mit Blick auf das Thema der eigenen Herz-Kreislauf-Gesundheit gefordert und gefordert werden. Spielerisch und dennoch in realitatsnahen Szenarien und Aufgaben uberprufen die Schuler*innen ihr Wissen und ihre Handlungsfahigkeit. Wie funktioniert und adaptiert sich das menschliche Herz-Kreislauf-System? Worauf kommt es bei der Wiederbelebung an und wie arbeite ich im Team? Wie erkenne ich akute Kreislaufstorungen und wie reagiere ich darauf? Diese im vorhergehenden Unterricht thematisierten Fragen greift die Olympiade beispielhaft auf und ist daher auch anschlussfahig an Inhalte und Kompetenzziele von Lehrplanen etwa in Sport und Biologie. Der Beitrag ordnet das Material in einen didaktisch-empirischen Kontext ein und prasentiert die Unterrichtsmaterialien zusammen mit Hinweisen fur die Nutzung durch Lehrkrafte.
Zusammenfassung Hintergrund Wiederbelebungsunterricht ist nicht in allen Schulen Deutschlands verpflichtend, dieser beschränkt sich trotz niedriger Laienreanimationsrate aktuell auf einzelne, z. T verpflichtende Projekte in unterschiedlichen Bundesländern. Aus diesem Grunde hat das Ministerium für Schule und Bildung Nordrhein-Westfalen per Runderlass im März 2017 das Projekt „Laienreanimation an Schulen in NRW“ initiiert. Fragestellung Ziel dieser Arbeit ist die Evaluation dieses Projekts. Material und Methoden Alle weiterführenden Schulen in Nordrhein-Westfalen wurden zur Teilnahme am Projekt eingeladen. Aus jedem Regierungsbezirk nahmen ärztliche Partner teil, welche Wiederbelebungstrainings mit bereits bestehenden Konzepten zum Lehrer- oder Schülertraining durchführten. Nach einer 3‑jährigen Laufzeit erfolgte die Evaluation anhand von standardisierten Fragebögen für Schuldezernenten, Lehrer und Schüler. Ergebnisse Insgesamt konnten durch das Projekt mehr als 40.000 Schüler aus 249 Schulen in NRW mit 6 unterschiedlichen Konzepten in Wiederbelebung trainiert werden. Fragen bezüglich Wiederbelebungsmaßnahmen konnten durch 85 % der Schüler richtig beantwortet werden. Die Schüler fühlen sich insgesamt sicher in Wiederbelebungsmaßnahmen. Der Investitionsbedarf für alle Schulen liegt bei einmalig zwischen 4 und 6,5 Mio. € sowie rund 340.000 € in jedem Haushaltsjahr. Diskussion Eine gesetzliche Verpflichtung und Finanzierung von Wiederbelebungstrainings sind unerlässlich für eine flächendeckende Durchführung. Alle durchgeführten Konzepte sind effektiv, dementsprechend kann jede Schule ein auf ihre Bedürfnisse abgestimmtes Konzept auswählen und dieses bestenfalls gestuft anwenden. Die Schulung von Lehrern sollte gezielt auf Wiederbelebung ausgerichtet sein.
Background Language barriers in doctor-patient interactions are still an understudied phenomenon. This is particularly true concerning interactions with immigrant physicians who are learners of the patient’s language; there is a lack of research even though labour migration is increasing internationally. This conversation analytical study focusses on language errors in one specific type of doctor-patient interaction, namely pre-anaesthesia evaluations with immigrant anaesthetists. Methods The study combines the research field of language acquisition with that of medical interaction. It is a qualitative study with an ethnomethodological framework which addresses the following research question: How do language errors, produced by immigrant anaesthetists, impact pre-anaesthesia evaluations? The primary data comes from naturally occurring pre-anaesthesia evaluations carried out by immigrant anaesthetists. The analysis method is a combination of conversation and error analysis. Results The study shows that the anaesthetists produced a considerable number of unintelligible utterances, due to various language errors. Despite the lack of understanding, hardly any negotiation of meaning occurred and both sides (anaesthetists and patients) claimed to be satisfied. Conclusions The findings appear to be contradictory. An explanation for this can be found in the effect of the roles and scripts that are given in pre-anaesthesia evaluations. Since no negotiation of meaning is initiated during the interactions, the anaesthetists’ insufficient language competence leads to a considerable impairment of informed consent, which is the main goal of the pre-anaesthesia evaluations. Based on these findings, the study reveals an urgent need for action regarding immigrant anaesthetists’ language skills.
OBJECTIVES In a multicentre, randomized-controlled, phase III trial in complex cardiovascular surgery (Randomized Evaluation of Fibrinogen vs Placebo in Complex Cardiovascular Surgery: REPLACE), single-dose human fibrinogen concentrate (FCH) was associated with the transfusion of increased allogeneic blood products (ABPs) versus placebo. Post hoc analyses were performed to identify possible reasons for this result. METHODS We stratified REPLACE results by adherence to the transfusion algorithm, pretreatment fibrinogen level (≤2 g/l vs >2 g/l) and whether patients were among the first 3 treated at their centre. RESULTS Patients whose treatment was adherent with the transfusion algorithm [FCH, n = 47 (60.3%); placebo, n = 57 (77.0%); P = 0.036] received smaller quantities of ABPs than those with non-adherent treatment (P < 0.001). Among treatment-adherent patients with pretreatment plasma fibrinogen ≤2 g/l, greater reduction in 5-min bleeding mass was seen with FCH versus placebo (median -22.5 g vs -15.5 g; P = 0.071). Considering patients with the above conditions and not among the first 3 treated at their centre (FCH, n = 15; placebo, n = 22), FCH was associated with trends towards reduced transfusion of ABPs (median 2.0 vs 4.0 units; P = 0.573) and greater reduction in 5-min bleeding mass (median -21.0 g vs -9.5 g; P = 0.173). Differences from a preceding single-centre phase II study with positive outcomes included more patients with pretreatment fibrinogen >2 g/l and fewer patients undergoing thoracoabdominal aortic aneurysm repair. CONCLUSIONS None of the patient stratifications provided a clear explanation for the lack of efficacy seen for FCH in the REPLACE trial versus the positive phase II outcomes. However, together, the 3 factors demonstrated trends favouring FCH. Less familiarity with the protocol and procedures and unavoidable differences in the study populations may explain the differences seen between the phase II study and REPLACE. CLINICAL TRIAL REGISTRATION NCT01475669 https://clinicaltrials.gov/ct2/show/NCT01475669; EudraCT trial no: 2011-002685-20.