coagulation management

凝血管理
  • 文章类型: Journal Article
    背景:数十年来,新鲜冰冻血浆(FFP)输血一直是止血干预的主要手段,用于治疗肝移植(LT)过程中出现的出血和凝血异常。然而,大量临床研究表明,FFP有许多副作用,包括病原体传播的风险,输血相关循环超负荷(TACO),输血相关免疫调节(TRIM),和输血相关急性肺损伤(TRALI)。这些不良事件在接受LT的患者中尤其具有挑战性。经常患有严重的门静脉高压症,肾功能差和并存的心脏病。这篇综述的目的是总结目前可用的PCCs的药理特性,代表在接受LT的患者中使用这些药物的理论益处和可能的风险,and,最后,回顾当前有关该主题的文献,以强调目前支持在LT患者中使用PCC的证据。方法:回顾了当前有关该主题的文献,以强调目前支持在LT患者中使用PCC的证据。结果:与FFP相比,凝血酶原复合物浓缩物(PCCs)可能具有多种优势。的确,PCCs已被证明可以降低TACO的风险,在肝移植期间可能会恶化门静脉高压,增加术中出血,并可能降低生存率。PCC使用的主要问题之一是血栓形成性。然而,目前可用的PCCs更安全,因为它们含有灭活形式的维生素K依赖性凝血因子和蛋白C,蛋白质S,抗凝血酶和/或肝素。如今,使用PCCs纠正LT期间发生的凝血异常是一种越来越普遍的做法.然而,目前尚不清楚支持这种做法的证据水平,以及与之相关的风险是什么。结论:在LT患者中给予PCC以纠正止血异常似乎耐受性良好,但术后使用PCC与血栓栓塞事件之间的关系尚不清楚.足够的动力,迫切需要方法学上合理的试验,以获得更明确的结论,即在广泛表型的LT受体中PCCs的疗效和安全性.
    Background: Fresh frozen plasma (FFP) transfusions have been the mainstay of hemostatic intervention for the treatment of bleeding and coagulation abnormalities arising during liver transplantation (LT) for decades. However, numerous clinical studies showed that FFP has many side effects, including the risk of pathogen transmission, transfusion-associated circulatory overload (TACO), transfusion-related immunomodulation (TRIM), and transfusion-related acute lung injury (TRALI). These adverse events are particularly challenging in patients undergoing LT, who often suffer from severe portal hypertension, poor renal function and coexisting cardiac disease.The aims of this review are to summarize the pharmacological properties of currently available PCCs, to represent the theoretical benefits and the possible risks related to the use of these drugs in patients undergoing LT, and, finally, to review the current literature on the topic in order to highlight the evidence that currently supports PCC use in LT patients. Methods: The current literature on the topic was reviewed in order to highlight the evidence that currently supports PCC use in LT patients. Results: Prothrombin complex concentrates (PCCs) may offer several advantages when compared to FFP. Indeed, PCCs have been shown to reduce the risk of TACO, which during liver transplantation may deteriorate portal hypertension, increase intraoperative bleeding, and possibly reduce survival rates. One of the major concerns for PCC use is thrombogenicity. However, currently available PCCs are much safer as they contain inactivated forms of the vitamin K-dependent coagulation factors and protein C, protein S, antithrombin and/or heparin. Nowadays, the use of PCCs to correct coagulation abnormalities that occur during LT is an increasingly widespread practice. However, it is not yet clear what level of evidence supports this practice, and what the risks associated with it are. Conclusions: Administration of PCC in LT patients to correct haemostatic abnormalities seems to be well-tolerated, but the relationship between PCC use and thromboembolic events in the postoperative period remains unclear. Adequately powered, methodologically sound trials are urgently required for more definitive conclusions about the efficacy and safety of PCCs in a broad phenotype of LT recipients.
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  • 文章类型: Journal Article
    背景:脊柱转移需要手术的患者的年龄,主要是65岁以上的人,由于癌症治疗的改善而上升。手术干预的目标是急性神经功能缺损和不稳定。抗凝剂的使用越来越多,尤其是老年人,但在管理出血并发症方面构成挑战。该研究检查了术前抗凝/抗血小板使用与脊柱转移手术中出血风险之间的相关性。这对于优化患者预后至关重要。
    方法:在我科2010年至2023年的一项回顾性研究中,对脊柱肿瘤手术患者进行了分析。数据包括人口统计,神经状况,外科手术,术前抗凝血剂/抗血小板使用,术中/术后凝血管理,和再出血的发生率。凝血管理包括失血评估,凝血因子给药,和术后液体平衡监测。入院时记录实验室参数,preop,posop,和放电。
    结果:290例脊柱转移瘤患者接受手术治疗,主要是男性(63.8%,n=185),中位年龄为65岁。术前,24.1%(n=70)接受口服抗凝剂或抗血小板治疗。30天内,再出血率为4.5%(n=9),与术前抗凝状态无关(p>0.05)。术前神经功能缺损(p=0.004)与再出血风险和手术治疗水平之间存在相关性,与较少的水平与较高的术后出血发生率相关(p<0.01)。
    结论:无论患者的术前抗凝状态如何,脊柱转移癌的手术干预似乎都是安全的。然而,仍然必须为每位患者定制术前计划和准备,强调细致的风险-效益分析和优化围手术期护理。
    BACKGROUND: The age of patients requiring surgery for spinal metastasis, primarily those over 65, has risen due to improved cancer treatments. Surgical intervention targets acute neurological deficits and instability. Anticoagulants are increasingly used, especially in the elderly, but pose challenges in managing bleeding complications. The study examines the correlation between preoperative anticoagulant/antiplatelet use and bleeding risks in spinal metastasis surgery, which is crucial for optimizing patient outcomes.
    METHODS: In a retrospective study at our department from 2010 to 2023, spinal tumor surgery patients were analyzed. Data included demographics, neurological status, surgical procedure, preoperative anticoagulant/antiplatelet use, intra-/postoperative coagulation management, and the incidence of rebleeding. Coagulation management involved blood loss assessment, coagulation factor administration, and fluid balance monitoring post-surgery. Lab parameters were documented at admission, preop, postop, and discharge.
    RESULTS: A cohort of 290 patients underwent surgical treatment for spinal metastases, predominantly males (63.8%, n = 185) with a median age of 65 years. Preoperatively, 24.1% (n = 70) were on oral anticoagulants or antiplatelet therapy. Within 30 days, a rebleeding rate of 4.5% (n = 9) occurred, unrelated to preoperative anticoagulation status (p > 0.05). A correlation was found between preoperative neurologic deficits (p = 0.004) and rebleeding risk and the number of levels treated surgically, with fewer levels associated with a higher incidence of postoperative bleeding (p < 0.01).
    CONCLUSIONS: Surgical intervention for spinal metastatic cancer appears to be safe regardless of the patient\'s preoperative anticoagulation status. However, it remains imperative to customize preoperative planning and preparation for each patient, emphasizing meticulous risk-benefit analysis and optimizing perioperative care.
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  • 文章类型: Randomized Controlled Trial
    背景:指南建议使用粘弹性凝血测试来指导凝血管理,但是解释结果仍然具有挑战性。视觉凝块,3D动画血块,通过以用户为中心和以情境意识为导向的设计来促进解释。
    目的:本研究旨在比较VisualClot与常规粘弹性测试结果(旋转血栓弹测仪[ROTEM]模板图)对危重出血情况下麻醉团队凝血管理绩效的影响。
    方法:我们进行了前瞻性,随机化,高保真模拟研究,其中麻醉团队(由一名高级麻醉师组成,住院医师,和麻醉护士)管理围手术期出血情况。团队具有可用于进行针对性凝血管理的视觉凝块或ROTEM模板。我们用事后视频分析分析了15分钟的模拟。主要结果是正确的靶向凝血治疗。次要结果是靶向凝血治疗的时间,信心,和工作量。此外,我们对用户对VisualClot的接受度进行了定性调查。我们使用泊松回归,Cox回归,和混合逻辑回归模型,针对各种潜在的混杂因素进行了调整,来分析数据。
    结果:我们分析了59个模拟。使用视觉凝块的团队更有可能正确提供整体靶向凝血治疗(比率1.56,95%CI1.00-2.47;P=0.05),并更快地使用第一个靶向凝血产品(风险比2.58,95%CI1.37-4.85;P=.003)。此外,参与者对视觉凝块显示更高的决策信心(比值比3.60,95%CI1.49-8.71;P=.005).我们发现工作量没有差异(系数-0.03,95%CI-3.08至2.88;P=.99)。
    结论:使用视觉凝块导致比使用ROTEM模板更准确和更快的靶向凝血治疗。我们建议相关粘弹性测试制造商考虑以直观的方式增强其复杂的结果呈现,易于理解的可视化,以减轻用户不必要的认知负担,并增强患者护理。
    Guidelines recommend using viscoelastic coagulation tests to guide coagulation management, but interpreting the results remains challenging. Visual Clot, a 3D animated blood clot, facilitates interpretation through a user-centered and situation awareness-oriented design.
    This study aims to compare the effects of Visual Clot versus conventional viscoelastic test results (rotational thrombelastometry [ROTEM] temograms) on the coagulation management performance of anesthesia teams in critical bleeding situations.
    We conducted a prospective, randomized, high-fidelity simulation study in which anesthesia teams (consisting of a senior anesthesiologist, a resident anesthesiologist, and an anesthesia nurse) managed perioperative bleeding scenarios. Teams had either Visual Clot or ROTEM temograms available to perform targeted coagulation management. We analyzed the 15-minute simulations with post hoc video analysis. The primary outcome was correct targeted coagulation therapy. Secondary outcomes were time to targeted coagulation therapy, confidence, and workload. In addition, we have conducted a qualitative survey on user acceptance of Visual Clot. We used Poisson regression, Cox regression, and mixed logistic regression models, adjusted for various potential confounders, to analyze the data.
    We analyzed 59 simulations. Teams using Visual Clot were more likely to deliver the overall targeted coagulation therapy correctly (rate ratio 1.56, 95% CI 1.00-2.47; P=.05) and administer the first targeted coagulation product faster (hazard ratio 2.58, 95% CI 1.37-4.85; P=.003). In addition, participants showed higher decision confidence with Visual Clot (odds ratio 3.60, 95% CI 1.49-8.71; P=.005). We found no difference in workload (coefficient -0.03, 95% CI -3.08 to 2.88; P=.99).
    Using Visual Clot led to a more accurate and faster-targeted coagulation therapy than using ROTEM temograms. We suggest that relevant viscoelastic test manufacturers consider augmenting their complex result presentation with intuitive, easy-to-understand visualization to ease users\' burden from unnecessary cognitive load and enhance patient care.
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  • 文章类型: Journal Article
    粘弹性点护理止血复苏方法,如ROTEM或TEG,在决定时间有效的个性化凝血干预措施方面至关重要。国际输血指南强调提高患者安全性和降低治疗成本。我们分析了护理提供者对ROTEM的看法,以确定感知的优势和需要改进的领域。我们进行了一个单中心,混合的定性-定量研究,包括访谈和在线调查。使用模板方法,我们首先在护理提供者给出的关于ROTEM的回答中确定了主题。稍后,参与者在一份在线问卷中,根据李克特五点量表确定的主题对6项陈述进行了评分.采访了77名参与者,52人完成了在线调查。通过分析用户的看法,我们确定了十个主题。最常见的正面主题是“高精度”。最常见的负面主题是“需要培训”。在在线调查中,94%的参与者认为监测实时ROTEM模板有助于更快地启动靶向治疗,81%的参与者认为反复ROTEM训练是有益的。麻醉护理提供者发现ROTEM是准确且快速的,可以在动态和复杂的止血情况下支持决策。然而,临床医生认为,解释ROTEM是一项复杂且认知要求很高的任务,需要大量的培训需求。
    Viscoelastic point-of-care haemostatic resuscitation methods, such as ROTEM or TEG, are crucial in deciding on time-efficient personalised coagulation interventions. International transfusion guidelines emphasise increased patient safety and reduced treatment costs. We analysed care providers\' perceptions of ROTEM to identify perceived strengths and areas for improvement. We conducted a single-centre, mixed qualitative-quantitative study consisting of interviews followed by an online survey. Using a template approach, we first identified themes in the responses given by care providers about ROTEM. Later, the participants rated six statements based on the identified themes on five-point Likert scales in an online questionnaire. Seventy-seven participants were interviewed, and 52 completed the online survey. By analysing user perceptions, we identified ten themes. The most common positive theme was \"high accuracy\". The most common negative theme was \"need for training\". In the online survey, 94% of participants agreed that monitoring the real-time ROTEM temograms helps to initiate targeted treatment more quickly and 81% agreed that recurrent ROTEM training would be beneficial. Anaesthesia care providers found ROTEM to be accurate and quickly available to support decision-making in dynamic and complex haemostatic situations. However, clinicians identified that interpreting ROTEM is a complex and cognitively demanding task that requires significant training needs.
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  • 文章类型: Journal Article
    背景:严重烧伤的患者同时患有凝血病和体温过低,缺乏国际共识和适当的治疗指南。这项研究探讨了欧洲烧伤中心凝血和温度管理的最新发展和趋势。
    方法:向瑞士的烧伤中心发送了一项调查,奥地利和德国分别在2016年和2021年。使用描述性统计进行分析,分类数据以绝对数(n)和百分比(%)报告,数字数据以平均值和标准偏差报告。
    结果:2016年完成的问卷率为84%(19份问卷中的16份),2021年为91%(22份问卷中的21份)。在观察期间,进行的全局凝血测试的数量有所减少,以单因素测定和床侧护理点凝血测试为支持。这也导致单因子浓缩物在治疗中的施用增加。尽管许多中心在2016年有明确的低温治疗方案,但覆盖率增加,因此在2021年,所有接受调查的中心都有这样的方案。2021年体温测量更加一致;因此,更积极地寻求低温,检测和治疗。
    结论:指导护理点,近年来,基于因子的凝血管理和维持正常体温在烧伤患者的护理中越来越重要。
    Severely burned patients suffer from both coagulopathy and hypothermia, with a lack of international consensus and appropriate treatment guidelines. This study examines recent developments and trends in coagulation and temperature management in European burn centers.
    A survey was sent to burn centers in Switzerland, Austria and Germany in 2016 and again in 2021. The analysis was performed using descriptive statistics, with categorical data reported in absolute numbers (n) and percentages (%) and numerical data reported as mean and standard deviation.
    The rate of completed questionnaires was 84 % (16 of 19 questionnaires) in 2016 and 91 % (21 of 22 questionnaires) in 2021. The number of global coagulation tests performed has decreased over the observation period in favor of single factor determination and bed-side point-of-care coagulation tests. This has also led to increased administration of single factor concentrates in therapy. Although many centers had a defined treatment protocol for hypothermia in 2016, coverage increased such that in 2021 all centers surveyed had such a protocol. The body temperature was measured more consistently in 2021; thus, hypothermia was more actively sought, detected and treated.
    A point-of-care guided, factor-based coagulation management and the maintenance of normothermia have gained importance in the care of burn patients in recent years.
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  • 文章类型: Journal Article
    关于创伤引起的大出血和凝血病的管理的欧洲指南总结了创伤凝血病管理的最相关建议。创伤引起的大出血的管理应跨学科遵循区分危及生命和非危及生命的出血的算法。护理点粘弹性方法(VEM)辅助目标控制的止血治疗。常规凝血测定法和VEM均不应延迟危及生命的创伤引起的出血的治疗。因地制宜,调整可能是合理的,包括血液制品的供应,制药,和员工。
    The European guideline on the management of trauma-induced major bleeding and coagulopathy summarises the most relevant recommendations for trauma coagulopathy management. The management of trauma-induced major bleeding should interdisciplinary follow algorithms which distinguish between life-threatening and non-life-threatening bleeding. Point-of-care viscoelastic methods (VEM) assist target-controlled haemostatic treatment. Neither conventional coagulation assays nor VEM should delay treatment in life-threatening trauma-induced bleeding. Adjustments may be rational due to local circumstances, including the availability of blood products, pharmaceuticals, and employees.
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  • 文章类型: Journal Article
    Viscoelastic test-guided coagulation management has become increasingly important in assessing hemostasis. We developed Visual Clot, an animated, 3D blood clot that illustrates raw rotational thromboelastometry (ROTEM) parameters in a user-centered and situation awareness-oriented method.
    This study aimed to evaluate the applicability of Visual Clot by examining its effects on users that are novices in viscoelastic-guided resuscitation.
    We conducted an investigator-initiated, international, multicenter study between September 16, 2020, and October 6, 2020, in 5 tertiary care hospitals in central Europe. We randomly recruited medical students and inexperienced resident physicians without significant prior exposure to viscoelastic testing. The 7 participants per center managed 9 different ROTEM outputs twice, once as standard ROTEM tracings and once as the corresponding Visual Clot. We randomly presented the 18 viscoelastic cases and asked the participants for their therapeutic decisions. We assessed the performance, diagnostic confidence, and perceived workload in managing the tasks using mixed statistical models and adjusted for possible confounding factors.
    Analyzing a total of 630 results, we found that the participants solved more cases correctly (odds ratio [OR] 33.66, 95% CI 21.13-53.64; P<.001), exhibited more diagnostic confidence (OR 206.2, 95% CI 93.5-454.75; P<.001), and perceived less workload (coefficient -41.63; 95% CI -43.91 to -39.36; P<.001) using Visual Clot compared to using standard ROTEM tracings.
    This study emphasizes the practical benefit of presenting viscoelastic test results in a user-centered way. Visual Clot may allow inexperienced users to be involved in the decision-making process to treat bleeding-associated coagulopathy. The increased diagnostic confidence, diagnostic certainty, reduced workload, and positive user feedback associated with this visualization may promote the further adoption of viscoelastic methods in diverse health care settings.
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  • 文章类型: Journal Article
    Acute bleeding is an omnipresent challenge for all physicians. Uncontrolled hemorrhage is the most common preventable cause of death after trauma worldwide. In different surgical disciplines, hemorrhage represents an independent risk factor for increased postoperative morbimortality, directly affecting patients\' outcomes. This study asked anesthesiologists about their personal perceived challenges when treating bleeding patients.
    This investigator-initiated, prospective, international, dual-center, mixed qualitative and quantitative study interrogated anesthesiologists about what they found easy and what difficult in treating acutely bleeding patients. Following the template approach for qualitative research, we identified major and minor topics through free inductive coding and word count. In a second step, we derived ten statements from the participants\' answers. Using a field survey, we then asked the participants to rate their level of agreement with the derived statements. We analyzed the answers using one sample Wilcoxon test and the Mann-Whitney test.
    We included a total of 84 physicians in the qualitative interrogations and a different group of 42 anesthesiologists in the quantitative part. We identified 11 major topics and 19 associated subtopics. The main topics and the degree of agreement (here as agree or strongly agree) were as follows: \"Complexity of the topic\" (52.4% agreed to find the topic complex), \"Cognitive aids\" (92.9% agreed to find them helpful), \"Time management\" (64.3% agreed to feeling time pressure), \"Human factors\" (95.2% agreed that human factors are essential), \"Resources\" (95.2% agreed that resources are essential), \"Experience\" and \"Low frequency of cases\" (57.1% agreed to lack practice), \"Diagnostic methods\" (31.0% agreed that the interpretation of test results is difficult), \"Anticoagulation\" (85.7% agreed to it being difficult), \"Treatment\" (81.0% agreed to knowing the first therapeutic steps), and \"Nothing\".
    Anesthesiologists in two large tertiary care facilities in different parts of the world found coagulation management, especially in anticoagulated patients, complex. We identified the delayed diagnostic test results and their interpretation as challenges. Resources, treatment protocols and human factors such as team communication were perceived to facilitate management. Future studies should explore the challenges in smaller hospitals and other parts of the world and test new technologies addressing the identified difficulties.
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  • 文章类型: Journal Article
    OBJECTIVE: Proximal femoral fractures are common in Germany with approximately 100,000 affected patients per year. The mortality could be considerably reduced by timely treatment (<24 h). The objectives of this work were to demonstrate the prevalence of anticoagulation and associated complications in osteosynthetically treated proximal femoral fractures, the impact of anticoagulation on the preoperative period and potential optimization of perioperative anticoagulation management.
    METHODS: External quality control data for North Rhine-Westphalia for the years 2015-2016 were evaluated. Only cases in which a femoral fracture near the hip joint was treated osteosynthetically were analyzed. A total of 24,786 cases of femoral fractures near the hip joint were included in the study.
    RESULTS: In the largest subgroup with acetylsalicylic acid (ASS) medication (n = 4005) 17% underwent delayed surgery, in the second largest group with vitamin K antagonists (VKA, n = 2157) 44.6% underwent delayed surgery and in the third largest group with direct oral anticoagulant (DOACs) medication (n = 994) 18.2% underwent delayed surgery.
    CONCLUSIONS: The biggest potential of shortening the preoperative period can be found in the ASS and vitamin K antagonist subgroups (17% and 44.6% delayed surgery, respectively). The antagonization of the effect of VKA can be achieved within a short time by the administration of prothrombin complex (PPSB). Even when taking DOACs, the current common procedure of delayed surgical treatment must be critically questioned. A coagulation management should be established in the SOP. In addition to medical interventions (administration of antidotes), structures must be created that enable prompt care.
    UNASSIGNED: HINTERGRUND UND FRAGESTELLUNG: Proximale Femurfrakturen stellen mit ca. 100.000 Betroffenen/Jahr in Deutschland ein häufiges Krankheitsbild dar. Durch eine zeitnahe Versorgung (<24 h) konnte die Mortalität erheblich gesenkt werden. Ziele der Arbeit waren, die Prävalenz der Antikoagulation und hiermit assoziierte Komplikationen bei osteosynthetisch versorgter, proximaler Femurfraktur und deren Impact auf die präoperative Verweildauer zu analysieren und Potenziale zum optimalen perioperativen Gerinnungsmanagements aufzuzeigen.
    UNASSIGNED: Die Daten der externen vergleichenden Qualitätssicherung Nordrhein-Westfalen für die Jahre 2015 und 2016 wurden ausgewertet. Dabei wurden ausschließlich Fälle analysiert, bei denen eine hüftgelenknahe Femurfraktur osteosynthetisch versorgt wurde. Insgesamt wurden 24.786 Fälle hüftgelenknaher Femurfrakturen in die Studie eingeschlossen.
    UNASSIGNED: Von den Patienten mit einer antithrombotischen Dauertherapie (ATDT) wurden in der größten Subgruppe mit ASS-Medikation (n = 4005) 17 %, in der zweitgrößten Gruppe mit Vitamin-K-Antagonisten-Einnahme (n = 2157) 44,6 % und in der drittgrößten Gruppe mit Einnahme von direkten oralen Antikoagulanzien (DOAKs, n = 994) 18,2 % verzögert operiert.
    UNASSIGNED: Das größte Potenzial zur Verkürzung der präoperativen Verweildauer ergibt sich in der Gruppe der Patienten, die ASS (17 % auffällig) oder einen Vitamin-K-Antagonisten (VKA, 44,6 % auffällig) einnehmen. Eine Antagonisierung der Wirkung von VKA lässt sich innerhalb kurzer Zeit durch die Gabe von Prothrombinkomplex (PPSB) erreichen. Auch unter der Einnahme von DOAKs muss das noch gängige Prozedere einer verzögerten operativen Versorgung kritisch hinterfragt werden. Die Etablierung eines Gerinnungsmanagements ist zu fordern. Neben der medizinischen Intervention (Gabe von Antidota) müssen Strukturen geschaffen werden, die eine zeitnahe Versorgung ermöglichen.
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  • 文章类型: Journal Article
    止血交通灯是一种认知辅助工具,以用户为中心的设计,可增强和简化围手术期出血期间的情境意识和决策。其结构有助于根据病理生理学和出血的严重程度优先考虑治疗干预措施。这个调查员发起的,随机化,prospective,国际,双中心研究旨在通过使止血交通灯适应两家大学医院的局部凝血方案来验证止血交通灯。在2020年1月9日至5月12日期间,我们在苏黎世大学医院招募了84名参与者,瑞士,还有布宜诺斯艾利斯的意大利医院,阿根廷。每个中心包括21名住院医师和21名职员麻醉师。参与者被随机分配到基于文本的算法或止血交通灯。所有参与者使用相同的算法管理六个出血场景。在模拟出血情况下,止血交通灯算法的设计使案件得到了更正确的解决,或(95CI)7.23(3.82-13.68),p<0.001,更快的治疗决策,HR(95CI)1.97(1.18-3.29,p=0.010)。此外,该工具提高了治疗信心,OR(95CI)4.31(1.67-11.11,p=0.003),并降低了感知工作负荷系数(95CI)-6.1(-10.98至-1.22),p=0.020)。这项研究为以用户为中心的设计在制定止血管理协议中的重要性提供了经验证据。
    The Haemostasis Traffic Light is a cognitive aid with a user-centred design to enhance and simplify situation awareness and decision-making during peri-operative bleeding. Its structure helps to prioritise therapeutic interventions according to the pathophysiology and the severity of the bleeding. This investigator-initiated, randomised, prospective, international, dual-centre study aimed to validate the Haemostasis Traffic Light by adapting it to the local coagulation protocols of two university hospitals. Between 9 January and 12 May 2020, we recruited 84 participants at the University Hospital Zurich, Switzerland, and the Italian Hospital of Buenos Aires, Argentina. Each centre included 21 resident and 21 staff anaesthetists. Participants were randomly allocated to either the text-based algorithm or the Haemostasis Traffic Light. All participants managed six bleeding scenarios using the same algorithm. In simulated bleeding scenarios, the design of the Haemostasis Traffic Light algorithm enabled more correctly solved cases, OR (95%CI) 7.23 (3.82-13.68), p < 0.001, and faster therapeutic decisions, HR (95%CI) 1.97 (1.18-3.29, p = 0.010). In addition, the tool improved therapeutic confidence, OR (95%CI) 4.31 (1.67-11.11, p = 0.003), and reduced perceived work-load coefficient (95%CI) -6.1 (-10.98 to -1.22), p = 0.020). This study provides empirical evidence for the importance of user-centred design in the development of haemostatic management protocols.
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