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BACKGROUND AND PURPOSE: Direct transportation to a thrombectomy-capable intervention center is beneficial for patients with ischemic stroke due to large vessel occlusion (LVO), but can delay intravenous thrombolytics (IVT). The aim of this modeling study was to estimate the effect of prehospital triage strategies on treatment delays and overtriage in different regions. METHODS: We used data from two prospective cohort studies in the Netherlands: the Leiden Prehospital Stroke Study and the PRESTO study. We included stroke code patients within 6 h from symptom onset. We modeled outcomes of Rapid Arterial oCclusion Evaluation (RACE) scale triage and triage with a personalized decision tool, using drip-and-ship as reference. Main outcomes were overtriage (stroke code patients incorrectly triaged to an intervention center), reduced delay to endovascular thrombectomy (EVT), and delay to IVT. RESULTS: We included 1798 stroke code patients from four ambulance regions. Per region, overtriage ranged from 1-13% (RACE triage) and 3-15% (personalized tool). Reduction of delay to EVT varied by region between 24 ± 5 min (n = 6) to 78 ± 3 (n = 2), while IVT delay increased with 5 (n = 5) to 15 min (n = 21) for non-LVO patients. The personalized tool reduced delay to EVT for more patients (25 ± 4 min [n = 8] to 49 ± 13 [n = 5]), while delaying IVT with 3-14 min (8-24 patients). In region C, most EVT patients were treated faster (reduction of delay to EVT 31 ± 6 min (n = 35), with RACE triage and the personalized tool. CONCLUSIONS: In this modeling study, we showed that prehospital triage reduced time to EVT without disproportionate IVT delay, compared to a drip-and-ship strategy. The effect of triage strategies and the associated overtriage varied between regions. Implementation of prehospital triage should therefore be considered on a regional level.
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Isquemia Encefálica , Serviços Médicos de Emergência , Acidente Vascular Cerebral , Humanos , Triagem , Isquemia Encefálica/diagnóstico , Estudos Prospectivos , Acidente Vascular Cerebral/terapia , Acidente Vascular Cerebral/tratamento farmacológico , Fibrinolíticos/uso terapêutico , Terapia Trombolítica , Resultado do TratamentoRESUMO
BACKGROUND AND PURPOSE: Subfebrile body temperature and fever in the first days after stroke are strongly associated with unfavorable outcome. A subgroup analysis of a previous trial suggested that early treatment with paracetamol may improve functional outcome in patients with acute stroke and a body temperature of ≥36.5°C. In the present trial, we aimed to confirm this finding. METHODS: PAIS 2 (Paracetamol [Acetaminophen] in Stroke 2) was a multicenter, randomized, double-blind, placebo-controlled clinical trial. We aimed to include 1500 patients with acute ischemic stroke or intracerebral hemorrhage within 12 hours of symptom onset. Patients were treated with paracetamol in a daily dose of 6 g or matching placebo for 3 consecutive days. The primary outcome was functional outcome at 3 months, assessed with the modified Rankin Scale and analyzed with multivariable ordinal logistic regression. Because of slow recruitment and lack of funding, the study was stopped prematurely. RESULTS: Between December 2011 and October 2015, we included 256 patients, of whom 136 (53%) were allocated to paracetamol. In this small sample, paracetamol had no effect on functional outcome (adjusted common odds ratio, 1.15; 95% confidence interval, 0.74-1.79). There was no difference in the number of serious adverse events (paracetamol n=35 [26%] versus placebo n=28 [24%]). CONCLUSIONS: Treatment with high-dose paracetamol seemed to be safe. The effect of high-dose paracetamol on functional outcome remains uncertain. Therefore, a large trial of early treatment with high-dose paracetamol is still needed. CLINICAL TRIAL REGISTRATION: URL: http://www.trialregister.nl. Unique identifier: NTR2365.
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Acetaminofen/farmacologia , Antipiréticos/farmacologia , Isquemia Encefálica/complicações , Hemorragia Cerebral/complicações , Febre/tratamento farmacológico , Avaliação de Resultados em Cuidados de Saúde , Acidente Vascular Cerebral/tratamento farmacológico , Acetaminofen/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Antipiréticos/administração & dosagem , Método Duplo-Cego , Feminino , Febre/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/etiologiaRESUMO
BACKGROUND: In adults with acute stroke, infections occur commonly and are associated with an unfavourable functional outcome. In the Preventive Antibiotics in Stroke Study (PASS) we aimed to establish whether or not preventive antimicrobial therapy with a third-generation cephalosporin, ceftriaxone, improves functional outcome in patients with acute stroke. METHODS: In this multicentre, randomised, open-label trial with masked endpoint assessment, patients with acute stroke were randomly assigned to intravenous ceftriaxone at a dose of 2 g, given every 24 h intravenously for 4 days, in addition to stroke unit care, or standard stroke unit care without preventive antimicrobial therapy; assignments were made within 24 h after symptom onset. The primary endpoint was functional outcome at 3 months, defined according to the modified Rankin Scale and analysed by intention to treat. The primary analysis was by ordinal regression of the primary outcome. Secondary outcomes included death, infection rates, antimicrobial use, and length of hospital stay. Participants and caregivers were aware of treatment allocation but assessors of outcome were masked to group assignment. This trial is registered with controlled-trials.com, number ISRCTN66140176. FINDINGS: Between July 6, 2010, and March 23, 2014, a total of 2550 patients from 30 sites in the Netherlands, including academic and non-academic medical centres, were randomly assigned to the two treatment groups: 1275 patients to ceftriaxone and 1275 patients to standard treatment (control group). 12 patients (seven in the ceftriaxone group and five in the control group) withdrew consent immediately after randomisation, leaving 2538 patients available for the intention-to-treat-analysis (1268 in the ceftriaxone group and 1270 in the control group). 2514 (99%) of 2538 patients (1257 in each group) completed 3-month follow-up. Preventive ceftriaxone did not affect the distribution of functional outcome scores on the modified Rankin Scale at 3 months (adjusted common odds ratio 0·95 [95% CI 0·82-1·09], p=0·46). Preventive ceftriaxone did not result in an increased occurrence of adverse events. Overgrowth infection with Clostridium difficile occurred in two patients (<1%) in the ceftriaxone group and none in the control group. INTERPRETATION: Preventive ceftriaxone does not improve functional outcome at 3 months in adults with acute stroke. The results of our trial do not support the use of preventive antibiotics in adults with acute stroke. FUNDING: Netherlands Organization for Health Research and Development, Netherlands Heart Foundation, and the European Research Council.
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Antibacterianos/uso terapêutico , Ceftriaxona/uso terapêutico , Pneumonia/prevenção & controle , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/terapia , Infecções Urinárias/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Análise de Intenção de Tratamento , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Países Baixos , Pneumonia/diagnóstico , Pneumonia/epidemiologia , Estudos Prospectivos , Anos de Vida Ajustados por Qualidade de Vida , Recuperação de Função Fisiológica , Resultado do Tratamento , Infecções Urinárias/diagnóstico , Infecções Urinárias/epidemiologiaRESUMO
BACKGROUND: Intravenous thrombolysis is contraindicated in patients with ischaemic stroke with blood pressure higher than 185/110 mm Hg. Prevailing guidelines recommend to actively lower blood pressure with intravenous antihypertensive agents to allow for thrombolysis; however, there is no robust evidence for this strategy. Because rapid declines in blood pressure can also adversely affect clinical outcomes, several Dutch stroke centres use a conservative strategy that does not involve the reduction of blood pressure. We aimed to compare the clinical outcomes of both strategies. METHODS: Thrombolysis and Uncontrolled Hypertension (TRUTH) was a prospective, observational, cluster-based, parallel-group study conducted across 37 stroke centres in the Netherlands. Participating centres had to strictly adhere to an active blood-pressure-lowering strategy or to a non-lowering strategy. Eligible participants were adults (≥18 years) with ischaemic stroke who had blood pressure higher than 185/110 mm Hg but were otherwise eligible for intravenous thrombolysis. The primary outcome was functional status at 90 days, measured using the modified Rankin Scale and assessed through telephone interviews by trained research nurses. Secondary outcomes were symptomatic intracranial haemorrhage, the proportion of patients treated with intravenous thrombolysis, and door-to-needle time. All ordinal logistic regression analyses were adjusted for age, sex, stroke severity, endovascular thrombectomy, and baseline imbalances as fixed-effect variables and centre as a random-effect variable to account for the clustered design. Analyses were done according to the intention-to-treat principle, whereby all patients were analysed according to the treatment strategy of the participating centre at which they were treated. FINDINGS: Recruitment began on Jan 1, 2015, and was prematurely halted because of a declining inclusion rate and insufficient funding on Jan 5, 2022. Between these dates, we recruited 853 patients from 27 centres that followed an active blood-pressure-lowering strategy and 199 patients from ten centres that followed a non-lowering strategy. Baseline characteristics of participants from the two groups were similar. The 90-day mRS score was missing for 15 patients. The adjusted odds ratio (aOR) for a shift towards a worse 90-day functional outcome was 1·27 (95% CI 0·96-1·68) for active blood-pressure reduction compared with no active blood-pressure reduction. 798 (94%) of 853 patients in the active blood-pressure-lowering group were treated with intravenous thrombolysis, with a median door-to-needle time of 35 min (IQR 25-52), compared with 104 (52%) of 199 patients treated in the non-lowering group with a median time of 47 min (29-78). 42 (5%) of 852 patients in the active blood-pressure-lowering group had a symptomatic intracranial haemorrhage compared with six (3%) of 199 of those in the non-lowering group (aOR 1·28 [95% CI 0·62-2·62]). INTERPRETATION: Insufficient evidence was available to establish a difference between an active blood-pressure-lowering strategy-in which antihypertensive agents were administered to reduce blood pressure below 185/110 mm Hg-and a non-lowering strategy for the functional outcomes of patients with ischaemic stroke, despite higher intravenous thrombolysis rates and shorter door-to-needle times among those in the active blood-pressure-lowering group. Randomised controlled trials are needed to inform the use of an active blood-pressure-lowering strategy. FUNDING: Fonds NutsOhra.
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Anti-Hipertensivos , AVC Isquêmico , Terapia Trombolítica , Humanos , Feminino , Masculino , Países Baixos , Idoso , AVC Isquêmico/tratamento farmacológico , AVC Isquêmico/terapia , Terapia Trombolítica/métodos , Pessoa de Meia-Idade , Estudos Prospectivos , Anti-Hipertensivos/uso terapêutico , Anti-Hipertensivos/administração & dosagem , Hipertensão/tratamento farmacológico , Fibrinolíticos/administração & dosagem , Fibrinolíticos/uso terapêutico , Resultado do Tratamento , Idoso de 80 Anos ou mais , Pressão Sanguínea/fisiologia , Pressão Sanguínea/efeitos dos fármacosRESUMO
BACKGROUND AND OBJECTIVES: To investigate CSF findings in relation to clinical and electrodiagnostic subtypes, severity, and outcome of Guillain-Barré syndrome (GBS) based on 1,500 patients in the International GBS Outcome Study. METHODS: Albuminocytologic dissociation (ACD) was defined as an increased protein level (>0.45 g/L) in the absence of elevated white cell count (<50 cells/µL). We excluded 124 (8%) patients because of other diagnoses, protocol violation, or insufficient data. The CSF was examined in 1,231 patients (89%). RESULTS: In 846 (70%) patients, CSF examination showed ACD, which increased with time from weakness onset: ≤4 days 57%, >4 days 84%. High CSF protein levels were associated with a demyelinating subtype, proximal or global muscle weakness, and a reduced likelihood of being able to run at week 2 (odds ratio [OR] 0.42, 95% CI 0.25-0.70; p = 0.001) and week 4 (OR 0.44, 95% CI 0.27-0.72; p = 0.001). Patients with the Miller Fisher syndrome, distal predominant weakness, and normal or equivocal nerve conduction studies were more likely to have lower CSF protein levels. CSF cell count was <5 cells/µL in 1,005 patients (83%), 5-49 cells/µL in 200 patients (16%), and ≥50 cells/µL in 13 patients (1%). DISCUSSION: ACD is a common finding in GBS, but normal protein levels do not exclude this diagnosis. High CSF protein level is associated with an early severe disease course and a demyelinating subtype. Elevated CSF cell count, rarely ≥50 cells/µL, is compatible with GBS after a thorough exclusion of alternative diagnoses. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that CSF ACD (defined by the Brighton Collaboration) is common in patients with GBS.
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Síndrome de Guillain-Barré , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Contagem de Células , Líquido Cefalorraquidiano/citologia , Estudos de Coortes , Progressão da Doença , Síndrome de Guillain-Barré/líquido cefalorraquidiano , Síndrome de Guillain-Barré/diagnóstico , Síndrome de Guillain-Barré/patologia , Síndrome de Guillain-Barré/fisiopatologia , Internacionalidade , Síndrome de Miller Fisher/líquido cefalorraquidiano , Síndrome de Miller Fisher/diagnóstico , Síndrome de Miller Fisher/patologia , Síndrome de Miller Fisher/fisiopatologia , Prognóstico , Resultado do TratamentoRESUMO
BACKGROUND: Stroke is the main cause of disability in high income countries and ranks second as a cause of death worldwide. Infections occur frequently after stroke and may adversely affect outcome. Preventive antibiotic therapy in the acute phase of stroke may reduce infections and improve outcome. OBJECTIVES: 1. To assess whether preventive antibiotic therapy in patients with acute stroke reduces the risk of dependency and death at follow-up. 2. To assess whether preventive antibiotic therapy in patients with acute stroke reduces infection rate. SEARCH METHODS: We searched the Cochrane Stroke Group's Trials Register (October 2010); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 3); MEDLINE (1950 to October 2010) and EMBASE (1980 to October 2010). In an effort to identify further published, unpublished and ongoing trials we searched trials and research registers, scanned reference lists and contacted authors, colleagues and researchers in the field. SELECTION CRITERIA: Randomised controlled trials (RCTs) of preventive antibiotic therapy versus control (placebo or open control) in patients with acute ischaemic or haemorrhagic stroke. DATA COLLECTION AND ANALYSIS: Two authors independently selected articles and performed data extraction; we discussed and resolved discrepancies in a consensus meeting with a third observer. We contacted the study authors to obtain missing data when required. An independent observer assessed methodological quality. We calculated relative risks (RRs) for dichotomous outcomes, assessed heterogeneity amongst included studies and performed subgroup analyses on study quality. MAIN RESULTS: We included five studies involving 506 patients. Study population, study design, type of antibiotic and definition of infection differed considerably. The number of patients who died in the preventive antibiotic group was non-significantly reduced (33/248 (13%) versus 38/258 (15%), RR 0.85, 95% confidence interval (CI) 0.47 to 1.51); the number of dependent patients in the preventive antibiotic therapy group was also non-significantly reduced (97/208 (47%) versus 127/208 (61%), RR 0.67, 95% CI 0.32 to 1.43). Preventive antibiotic therapy did reduce the incidence of infections in patients with acute stroke from 36% to 22% (36/166 (22%) versus 61/169 (36%), RR 0.58, 95% CI 0.43 to 0.79). No major side-effects of preventive antibiotic therapy were reported. AUTHORS' CONCLUSIONS: In this meta-analysis, preventive antibiotic therapy seemed to reduce the risk of infection, but did not reduce the number of dependent or deceased patients. However, the included studies were small and heterogeneous. Large randomised trials are urgently needed.
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Antibacterianos/uso terapêutico , Infecções Bacterianas/prevenção & controle , Acidente Vascular Cerebral/complicações , Antibioticoprofilaxia/métodos , Infecções Bacterianas/mortalidade , Isquemia Encefálica/complicações , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/mortalidadeRESUMO
OBJECTIVE: Awareness campaigns advise the public to call emergency medical services (EMS) directly in case of suspected stroke. We aimed to explore patient and notification characteristics that influence direct EMS notification, the time to alert, and the time to treatment. METHODS: We performed a secondary analysis with data from the PRESTO study, a multi-center prospective observational cohort study that included patients with suspected stroke. We used multivariable binary logistic regression analyses to assess the association with direct EMS notification and multivariable linear regression analyses to assess the association with the onset-to-alert time, onset-to-needle time and onset-to-groin time. RESULTS: Of 436 included patients, 208 patients (48%) contacted EMS directly. FAST scores (aOR 1.45 for every point increase, 95%CI: 1.14-1.86), alert outside office hours (aOR 1.64 [1.05-2.55]), and onset-to-alert time (aOR for every minute less [≤55 min]: 0.96 [0.95-0.97]) were independently associated with direct EMS notification. Direct EMS call was independently associated with shorter onset-to-alert times (27 min [54-0.84]) and with shorter onset-to-needle times (-30 min [-51 to -10]). The association between direct EMS call and the onset-to-groin time was almost similar to the association with onset-to-needle time, though not statistically significant (univariable analysis: 23.7 min decrease [-103.7 to 56.2]). CONCLUSION: More than half of all patients with suspected stroke do not call EMS directly but call their GP instead. Patients with higher FAST scores, alert outside office hours, and a rapid alert, more often call EMS directly. Patients who call EMS directly are treated with IVT 30 min faster than patients who call the GP first. TRIAL REGISTRATION NUMBER: Netherlands Trial Register: NL7387, (www.trialregister.nl).
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Serviços Médicos de Emergência , Clínicos Gerais , Acidente Vascular Cerebral , Humanos , Estudos Prospectivos , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Fatores de Tempo , Tempo para o TratamentoRESUMO
BACKGROUND AND OBJECTIVES: The clinical course and outcome of the Guillain-Barré syndrome (GBS) are diverse and vary among regions. The modified Erasmus GBS Outcome Score (mEGOS), developed with data from Dutch patients, is a clinical model that predicts the risk of walking inability in patients with GBS. The study objective was to validate the mEGOS in the International GBS Outcome Study (IGOS) cohort and to improve its performance and region specificity. METHODS: We used prospective data from the first 1,500 patients included in IGOS, aged ≥6 years and unable to walk independently. We evaluated whether the mEGOS at entry and week 1 could predict the inability to walk unaided at 4 and 26 weeks in the full cohort and in regional subgroups, using 2 measures for model performance: (1) discrimination: area under the receiver operating characteristic curve (AUC) and (2) calibration: observed vs predicted probability of being unable to walk independently. To improve the model predictions, we recalibrated the model containing the overall mEGOS score, without changing the individual predictive factors. Finally, we assessed the predictive ability of the individual factors. RESULTS: For validation of mEGOS at entry, 809 patients were eligible (Europe/North America [n = 677], Asia [n = 76], other [n = 56]), and 671 for validation of mEGOS at week 1 (Europe/North America [n = 563], Asia [n = 65], other [n = 43]). AUC values were >0.7 in all regional subgroups. In the Europe/North America subgroup, observed outcomes were worse than predicted; in Asia, observed outcomes were better than predicted. Recalibration improved model accuracy and enabled the development of a region-specific version for Europe/North America (mEGOS-Eu/NA). Similar to the original mEGOS, severe limb weakness and higher age were the predominant predictors of poor outcome in the IGOS cohort. DISCUSSION: mEGOS is a validated tool to predict the inability to walk unaided at 4 and 26 weeks in patients with GBS, also in countries outside the Netherlands. We developed a region-specific version of mEGOS for patients from Europe/North America. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that the mEGOS accurately predicts the inability to walk unaided at 4 and 26 weeks in patients with GBS. TRIAL REGISTRATION INFORMATION: NCT01582763.
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Síndrome de Guillain-Barré , Criança , Estudos de Coortes , Síndrome de Guillain-Barré/diagnóstico , Síndrome de Guillain-Barré/terapia , Humanos , Avaliação de Resultados em Cuidados de Saúde , Prognóstico , Estudos ProspectivosRESUMO
INTRODUCTION: Early detection of large vessel occlusion (LVO) is essential to facilitate fast endovascular treatment. CT angiography (CTA) is used to detect LVO in suspected stroke patients. We aimed to assess the accuracy of CTA evaluations in daily clinical practice in a large cohort of suspected stroke patients. PATIENTS AND METHODS: We used data from the PRESTO study, a multicenter prospective observational cohort study that included suspected stroke patients between August 2018 and September 2019. Baseline CTAs were re-evaluated by an imaging core laboratory and compared to the local assessment. LVO was defined as an occlusion of the intracranial internal carotid artery, M1 segment, or basilar artery. Medium vessel occlusion (MeVO) was defined as an A1, A2, or M2 occlusion. We calculated the accuracy, sensitivity, and specificity to detect LVO and LVO+MeVO, using the core laboratory evaluation as reference standard. RESULTS: We included 656 patients. The core laboratory detected 89 LVOs and 74 MeVOs in 155 patients. Local observers missed 6 LVOs (7%) and 28 MeVOs (38%), of which 23 M2 occlusions. Accuracy of LVO detection was 99% (95% CI: 98-100%), sensitivity 93% (95% CI: 86-97%), and specificity 100% (95% CI: 99-100%). Accuracy of LVO+MeVO detection was 95% (95% CI: 93-96%), sensitivity 79% (95% CI: 72-85%), and specificity 99% (95% CI: 98-100%). DISCUSSION AND CONCLUSION: CTA evaluations in daily clinical practice are highly accurate and LVOs are adequately recognized. The detection of MeVOs seems more challenging. The evolving EVT possibilities emphasize the need to improve CTA evaluations in the acute setting.
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BACKGROUND: Due to the time-sensitive effect of endovascular treatment, rapid prehospital identification of large-vessel occlusion in individuals with suspected stroke is essential to optimise outcome. Interhospital transfers are an important cause of delay of endovascular treatment. Prehospital stroke scales have been proposed to select patients with large-vessel occlusion for direct transport to an endovascular-capable intervention centre. We aimed to prospectively validate eight prehospital stroke scales in the field. METHODS: We did a multicentre, prospective, observational cohort study of adults with suspected stroke (aged ≥18 years) who were transported by ambulance to one of eight hospitals in southwest Netherlands. Suspected stroke was defined by a positive Face-Arm-Speech-Time (FAST) test. We included individuals with blood glucose of at least 2·5 mmol/L. People who presented more than 6 h after symptom onset were excluded from the analysis. After structured training, paramedics used a mobile app to assess items from eight prehospital stroke scales: Rapid Arterial oCclusion Evaluation (RACE), Los Angeles Motor Scale (LAMS), Cincinnati Stroke Triage Assessment Tool (C-STAT), Gaze-Face-Arm-Speech-Time (G-FAST), Prehospital Acute Stroke Severity (PASS), Cincinnati Prehospital Stroke Scale (CPSS), Conveniently-Grasped Field Assessment Stroke Triage (CG-FAST), and the FAST-PLUS (Face-Arm-Speech-Time plus severe arm or leg motor deficit) test. The primary outcome was the clinical diagnosis of ischaemic stroke with a proximal intracranial large-vessel occlusion in the anterior circulation (aLVO) on CT angiography. Baseline neuroimaging was centrally assessed by neuroradiologists to validate the true occlusion status. Prehospital stroke scale performance was expressed as the area under the receiver operating characteristic curve (AUC) and was compared with National Institutes of Health Stroke Scale (NIHSS) scores assessed by clinicians at the emergency department. This study was registered at the Netherlands Trial Register, NL7387. FINDINGS: Between Aug 13, 2018, and Sept 2, 2019, 1039 people (median age 72 years [IQR 61-81]) with suspected stroke were identified by paramedics, of whom 120 (12%) were diagnosed with aLVO. Of all prehospital stroke scales, the AUC for RACE was highest (0·83, 95% CI 0·79-0·86), followed by the AUC for G-FAST (0·80, 0·76-0·84), CG-FAST (0·80, 0·76-0·84), LAMS (0·79, 0·75-0·83), CPSS (0·79, 0·75-0·83), PASS (0·76, 0·72-0·80), C-STAT (0·75, 0·71-0·80), and FAST-PLUS (0·72, 0·67-0·76). The NIHSS as assessed by a clinician in the emergency department did somewhat better than the prehospital stroke scales with an AUC of 0·86 (95% CI 0·83-0·89). INTERPRETATION: Prehospital stroke scales detect aLVO with acceptable-to-good accuracy. RACE, G-FAST, and CG-FAST are the best performing prehospital stroke scales out of the eight scales tested and approach the performance of the clinician-assessed NIHSS. Further studies are needed to investigate whether use of these scales in regional transportation strategies can optimise outcomes of patients with ischaemic stroke. FUNDING: BeterKeten Collaboration and Theia Foundation (Zilveren Kruis).
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Arteriopatias Oclusivas/diagnóstico , Serviços Médicos de Emergência/estatística & dados numéricos , AVC Isquêmico/diagnóstico , Idoso , Idoso de 80 Anos ou mais , Arteriopatias Oclusivas/líquido cefalorraquidiano , Arteriopatias Oclusivas/complicações , Estudos de Coortes , Angiografia por Tomografia Computadorizada , Feminino , Humanos , AVC Isquêmico/líquido cefalorraquidiano , AVC Isquêmico/etiologia , Masculino , Pessoa de Meia-Idade , Países Baixos , Estudos Prospectivos , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Resultado do TratamentoRESUMO
BACKGROUND: Treatment with one standard dose (2 g/kg) of intravenous immunoglobulin is insufficient in a proportion of patients with severe Guillain-Barré syndrome. Worldwide, around 25% of patients severely affected with the syndrome are given a second intravenous immunoglobulin dose (SID), although it has not been proven effective. We aimed to investigate whether a SID is effective in patients with Guillain-Barré syndrome with a predicted poor outcome. METHODS: In this randomised, double-blind, placebo-controlled trial (SID-GBS), we included patients (≥12 years) with Guillain-Barré syndrome admitted to one of 59 participating hospitals in the Netherlands. Patients were included on the first day of standard intravenous immunoglobulin treatment (2 g/kg over 5 days). Only patients with a poor prognosis (score of ≥6) according to the modified Erasmus Guillain-Barré syndrome Outcome Score were randomly assigned, via block randomisation stratified by centre, to SID (2 g/kg over 5 days) or to placebo, 7-9 days after inclusion. Patients, outcome adjudicators, monitors, and the steering committee were masked to treatment allocation. The primary outcome measure was the Guillain-Barré syndrome disability score 4 weeks after inclusion. All patients in whom allocated trial medication was started were included in the modified intention-to-treat analysis. This study is registered with the Netherlands Trial Register, NTR 2224/NL2107. FINDINGS: Between Feb 16, 2010, and June 5, 2018, 327 of 339 patients assessed for eligibility were included. 112 had a poor prognosis. Of those, 93 patients with a poor prognosis were included in the modified intention-to-treat analysis: 49 (53%) received SID and 44 (47%) received placebo. The adjusted common odds ratio for improvement on the Guillain-Barré syndrome disability score at 4 weeks was 1·4 (95% CI 0·6-3·3; p=0·45). Patients given SID had more serious adverse events (35% vs 16% in the first 30 days), including thromboembolic events, than those in the placebo group. Four patients died in the intervention group (13-24 weeks after randomisation). INTERPRETATION: Our study does not provide evidence that patients with Guillain-Barré syndrome with a poor prognosis benefit from a second intravenous immunoglobulin course; moreover, it entails a risk of serious adverse events. Therefore, a second intravenous immunoglobulin course should not be considered for treatment of Guillain-Barre syndrome because of a poor prognosis. The results indicate the need for treatment trials with other immune modulators in patients severely affected by Guillain-Barré syndrome. FUNDING: Prinses Beatrix Spierfonds and Sanquin Plasma Products.
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Síndrome de Guillain-Barré/tratamento farmacológico , Imunoglobulinas Intravenosas/administração & dosagem , Adulto , Idoso , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Prognóstico , Resultado do TratamentoRESUMO
BACKGROUND: Infections are a common and serious threat to patients with acute ischemic stroke. The aim of this study was to assess the effect of infection on mortality and functional outcome at discharge and at 1 year. METHODS: From a consecutive cohort study in 11 centers, the Netherlands Stroke Survey, we selected 521 patients with ischemic stroke admitted to hospital within 48 h of onset. Stroke-associated infection was defined as infection occurring within 7 days after admission. Poor outcome (modified Rankin score >2) was recorded at discharge and at 1 year. RESULTS: Stroke-associated infection occurred in 78 patients (15%); 39 of these (7.5%) had pneumonia and 23 (4.4%) had urinary tract infection. Overall, 276 patients (53%) had a poor outcome at 1 year. Poor outcome was recorded in 69 patients with stroke-associated infection (88%), and 37 of the 78 patients with stroke-associated infection (47%) had died at 1 year. After adjustment for confounders, stroke-associated infection was associated with poor outcome at discharge [odds ratio (OR) 2.6, 95% confidence interval (CI) 1.0-6.7] and at 1 year (OR 3.8, 95% CI 1.8-8.9). Pneumonia had a stronger association with poor outcome at 1 year (OR 10, 95% CI 2.2-46). CONCLUSIONS: This study suggests that stroke-associated infection, in particular pneumonia, is independently associated with poor functional outcome after ischemic stroke.
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Inquéritos Epidemiológicos , Pneumonia/complicações , Acidente Vascular Cerebral/diagnóstico , Infecções Urinárias/complicações , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Pneumonia/epidemiologia , Prevalência , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/etnologia , Infecções Urinárias/epidemiologiaRESUMO
INTRODUCTION: The efficacy of both intravenous treatment (IVT) and endovascular treatment (EVT) for patients with acute ischaemic stroke strongly declines over time. Only a subset of patients with ischaemic stroke caused by an intracranial large vessel occlusion (LVO) in the anterior circulation can benefit from EVT. Several prehospital stroke scales were developed to identify patients that are likely to have an LVO, which could allow for direct transportation of EVT eligible patients to an endovascular-capable centre without delaying IVT for the other patients. We aim to prospectively validate these prehospital stroke scales simultaneously to assess their accuracy in predicting LVO in the prehospital setting. METHODS AND ANALYSIS: Prehospital triage of patients with suspected stroke symptoms (PRESTO) is a prospective multicentre observational cohort study in the southwest of the Netherlands including adult patients with suspected stroke in the ambulance. The paramedic will assess a combination of items from five prehospital stroke scales, without changing the normal workflow. Primary outcome is the clinical diagnosis of an acute ischaemic stroke with an intracranial LVO in the anterior circulation. Additional hospital data concerning the diagnosis and provided treatment will be collected by chart review. Logistic regression analysis will be performed, and performance of the prehospital stroke scales will be expressed as sensitivity, specificity and area under the receiver operator curve. ETHICS AND DISSEMINATION: The Institutional Review Board of the Erasmus MC University Medical Centre has reviewed the study protocol and confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) is not applicable. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations. The best performing scale, or the simplest scale in case of clinical equipoise, will be integrated in a decision model with other clinical characteristics and real-life driving times to improve prehospital triage of suspected stroke patients. TRIAL REGISTRATION NUMBER: NTR7595.
Assuntos
Trombose das Artérias Carótidas/diagnóstico , Serviços Médicos de Emergência/métodos , Infarto da Artéria Cerebral Anterior/diagnóstico , Infarto da Artéria Cerebral Média/diagnóstico , Triagem/métodos , Trombose das Artérias Carótidas/terapia , Artéria Carótida Interna , Procedimentos Endovasculares , Humanos , Infarto da Artéria Cerebral Anterior/terapia , Infarto da Artéria Cerebral Média/terapia , Modelos Logísticos , Países Baixos , Estudos Prospectivos , Curva ROC , Sensibilidade e Especificidade , Acidente Vascular Cerebral/diagnóstico , Trombectomia , Terapia TrombolíticaRESUMO
Carpal tunnel syndrome (CTS) may be the presenting symptom of an underlying disease such as diabetes mellitus, hypothyroidism or connective tissue disease (CTD). It was investigated whether additional blood tests (glucose level, thyroid-stimulating hormone level and erythrocyte sedimentation rate) are useful to detect diabetes mellitus, hypothyroidism or CTD in patients with CTS who have not been diagnosed with these diseases before. A group of 516 consecutive patients electromyographically diagnosed with CTS without known diabetes mellitus, hypothyroidism or CTD underwent blood tests and were followed up for incident diabetes mellitus, hypothyroidism or CTD to investigate whether these additional blood tests are useful to detect these diseases in patients with CTS. In our CTS population, only two patients were newly diagnosed with diabetes mellitus, two with hypothyroidism and none with CTD. In general, systematic screening for incident diabetes mellitus, hypothyroidism and CTD through additional blood tests seems to be of little additional value in otherwise typical cases of CTS.
Assuntos
Síndrome do Túnel Carpal/sangue , Doenças do Tecido Conjuntivo/diagnóstico , Complicações do Diabetes/diagnóstico , Hipotireoidismo/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Glicemia/análise , Sedimentação Sanguínea , Síndrome do Túnel Carpal/etiologia , Doenças do Tecido Conjuntivo/sangue , Doenças do Tecido Conjuntivo/complicações , Complicações do Diabetes/sangue , Complicações do Diabetes/complicações , Feminino , Humanos , Hipotireoidismo/sangue , Hipotireoidismo/complicações , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tireotropina/sangueRESUMO
BACKGROUND: Infections occur in 30% of stroke patients and are associated with unfavorable outcomes. Preventive antibiotic therapy lowers the infection rate after stroke, but the effect of preventive antibiotic treatment on functional outcome in patients with stroke is unknown. The PASS is a multicenter, prospective, phase three, randomized, open-label, blinded end-point (PROBE) trial of preventive antibiotic therapy in acute stroke. Patients are randomly assigned to either ceftriaxone at a dose of 2 g, given every 24 h intravenously for 4 days, in addition to standard stroke-unit care, or standard stroke-unit care without preventive antibiotic therapy. The aim of this study is to assess whether preventive antibiotic treatment improves functional outcome at 3 months by preventing infections. This paper presents in detail the statistical analysis plan (SAP) of the Preventive Antibiotics in Stroke Study (PASS) and was submitted while the investigators were still blinded for all outcomes. RESULTS: The primary outcome is the score on the modified Rankin Scale (mRS), assessed by ordinal logistic regression analysis according to a proportional odds model. Secondary analysis of the primary outcome is the score on the mRS dichotomized as a favorable outcome (mRS 0 to 2) versus unfavorable outcome (mRS 3 to 6). Secondary outcome measures are death rate at discharge and 3 months, infection rate during hospital admission, length of hospital admission, volume of post-stroke care, use of antibiotics during hospital stay, quality-adjusted life years and costs. Complications of treatment, serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) are reported as safety outcomes. CONCLUSIONS: The data from PASS will establish whether preventive antibiotic therapy in acute stroke improves functional outcome by preventing infection and will be analyzed according to this pre-specified SAP. TRIAL REGISTRATION: Current controlled trials; ISRCTN66140176. Date of registration: 6 April 2010.
Assuntos
Antibacterianos/administração & dosagem , Infecções Bacterianas/prevenção & controle , Ceftriaxona/administração & dosagem , Projetos de Pesquisa/estatística & dados numéricos , Acidente Vascular Cerebral/tratamento farmacológico , Antibacterianos/economia , Infecções Bacterianas/diagnóstico , Infecções Bacterianas/economia , Infecções Bacterianas/microbiologia , Infecções Bacterianas/mortalidade , Ceftriaxona/economia , Protocolos Clínicos , Análise Custo-Benefício , Interpretação Estatística de Dados , Avaliação da Deficiência , Esquema de Medicação , Custos de Medicamentos , Mortalidade Hospitalar , Humanos , Tempo de Internação , Modelos Logísticos , Países Baixos , Razão de Chances , Estudos Prospectivos , Qualidade de Vida , Recuperação de Função Fisiológica , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/fisiopatologia , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Stroke is a leading cause of death worldwide. Infections after stroke occur in 30% of stroke patients and are strongly associated with unfavourable outcome. Preventive antibiotic therapy lowers infection rate in patients after stroke, however, the effect of preventive antibiotic treatment on functional outcome after stroke has not yet been investigated.The Preventive Antibiotics in Stroke Study (PASS) is an ongoing, multicentre, prospective, randomised, open-label, blinded end point trial of preventive antibiotic therapy in acute stroke. Patients are randomly assigned to either ceftriaxone at a dose of 2 g, given every 24 hours intravenously for four-days, in addition to stroke-unit care, or standard stroke-unit care without preventive antibiotic therapy. Aim of the study is to assess whether preventive antibiotic treatment improves functional outcome at three months by preventing infections. RESULTS: To date, 2,470 patients have been included in PASS. Median stroke severity of the first 2,133 patients (second interim analysis) is 5 (IQR 3 to 9) on the National Institutes of Health Stroke Scale (NIHSS). Due to the PROBE design, no outcome data are available yet. In the initial trial protocol we proposed a dichotomisation of the mRS as primary analysis of outcome and ordinal regression analysis as secondary analysis of primary outcome, requiring a sample size of 3,200 patients. However, ordinal analysis of outcome data is becoming increasingly more common in acute stroke trials, as it increases statistical power. For PASS, funding is insufficient for inclusion of 3,200 patients with the overall inclusion rate of 15 patients per week. Therefore we change the analysis of our primary outcome from dichotomisation to ordinal regression analysis on the mRS. Power analysis showed that with similar assumptions 2,550 patients are needed using ordinal regression analysis. We expect to complete follow-up in June 2014. A full statistical analysis plan will be submitted for publication before treatment allocation will be unblinded. CONCLUSION: The data from PASS will establish whether preventive antibiotic therapy in acute stroke improves functional outcome by preventing infection. In this update, we changed our primary outcome analysis from dichotomisation to ordinal regression analysis. TRIAL REGISTRATION: Current controlled trials; ISRCTN66140176. Date of registration: 6 April 2010.
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Antibacterianos/administração & dosagem , Infecções Bacterianas/prevenção & controle , Ceftriaxona/administração & dosagem , Projetos de Pesquisa , Acidente Vascular Cerebral/tratamento farmacológico , Administração Intravenosa , Infecções Bacterianas/diagnóstico , Infecções Bacterianas/microbiologia , Protocolos Clínicos , Avaliação da Deficiência , Esquema de Medicação , Humanos , Seleção de Pacientes , Análise de Regressão , Tamanho da Amostra , Índice de Gravidade de Doença , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/diagnóstico , Fatores de Tempo , Resultado do TratamentoRESUMO
A substantial number of patients suffering from aortic dissection will show neurological signs. These can dominate the clinical picture and hinder an accurate diagnosis of this life-threatening disease. We present a case of lower extremity pain and a case of transient global amnesia caused by aortic dissection. A third patient suffered from acute cerebral ischemia accompanied by hypotension and back pain, suggestive of aortic dissection. In this third case, aortic dissection was excluded before systemic thrombolytic therapy was administered, for the patient could have suffered disastrous complications caused by this emergency stroke therapy. Clinicians should be aware that a wide range of cerebral, spinal and peripheral neurological signs can be caused by aortic dissection. An unusual combination of symptoms can be a clue for underlying aortic disease. High-risk clinical features are predisposing factors in medical history, typical acute onset back or chest pain, and pulse deficit, blood pressure asymmetry or a new cardiac murmur on physical examination. These features should be explicitly evaluated in patients with an acute neurological deficit. If neurological symptoms and a high-risk clinical feature are present, immediate aortic imaging should be considered since early detection can be life saving.
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Aneurisma Aórtico/diagnóstico , Dissecção Aórtica/diagnóstico , Adulto , Dissecção Aórtica/complicações , Aneurisma Aórtico/complicações , Dor no Peito/etiologia , Diagnóstico Diferencial , Humanos , Masculino , Pessoa de Meia-Idade , Doenças do Sistema Nervoso/diagnóstico , Doenças do Sistema Nervoso/etiologia , Exame Físico , Tomografia Computadorizada por Raios XRESUMO
UNLABELLED: Bariatric surgery is in general the only effective treatment for morbid obesity. Bariatric surgery is frequently associated with vitamin and mineral deficiencies which may lead to neurological and other symptoms. We describe a case of severe vitamin B1 (thiamine) deficiency. CASE DESCRIPTION: A 49-year-old man visited the emergency department with acute confusion, muscle weakness in arms and legs and visual impairment after a period of dysphagia and recurrent vomiting. Four months earlier, he had had bariatric gastric sleeve surgery for morbid obesity. Laboratory tests demonstrated that he had vitamin B1 deficiency, in view of which the diagnosis of beriberi and Wernicke encephalopathy was made. Despite normalisation of the vitamin B1 concentration following intravenous supplementation, the muscle strength hardly recovered and the patient developed Korsakov syndrome. CONCLUSION: For this deficiency there is no other treatment than vitamin B1 supplementation. Timely recognition of vitamin deficiencies and pro-active supplementation are essential in order to prevent serious complications following bariatric surgery.
Assuntos
Cirurgia Bariátrica/efeitos adversos , Síndrome de Korsakoff/etiologia , Tiamina/uso terapêutico , Encefalopatia de Wernicke/complicações , Encefalopatia de Wernicke/etiologia , Diagnóstico Precoce , Humanos , Síndrome de Korsakoff/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Obesidade Mórbida/cirurgia , Prognóstico , Resultado do Tratamento , Encefalopatia de Wernicke/tratamento farmacológicoRESUMO
RATIONALE: Stroke is a leading cause of death worldwide. Fever after stroke is a strong predictor of a poor outcome. Infections occur in up to 40% of patients with stroke and have also been associated with poor outcomes. Preventive antibiotic therapy lowers the infection rates in patients after stroke, as shown in a recent meta-analysis of randomised studies. Phase III trials evaluating the effect of antibiotic prophylaxis on clinical outcomes in sufficient numbers of patients with stroke have, however, not been performed to date. Ceftriaxone, an off-patent medicine, is an antibiotic with a broad defence against the bacteria that cause the most common infections after stroke. Preventive antibiotic therapy with ceftriaxone may potentially reduce poor outcome after acute stroke and, therefore, a randomised clinical trial is warranted. AIM: The aim of the present study is to investigate whether the preventive use of the antibiotic ceftriaxone improves functional outcome in patients with stroke. DESIGN: We will conduct a multicentre prospective, randomised, open-label, blinded end point trial of standard care with preventive ceftriaxone treatment and compare it with standard care without preventive ceftriaxone. Adult patients with stroke (both ischaemic and haemorrhagic) and a score ≥ 1 on the National Institutes of Health Stroke Scale will be included. The 3200 patients will be randomly assigned to two groups of 1600 patients. One group will receive standard care and ceftriaxone at a dose of 2 g, given every 24 h intravenously for four-days, and the other group will receive stroke-unit care without preventive antibiotic treatment. OUTCOMES: The primary end point will be functional outcome at a three-month follow-up on the modified Rankin Scale, dichotomised as a favourable outcome (0-2) or an unfavourable outcome (3-6). Secondary outcome measures will be death rate at discharge and three-months, infection rate during hospital admission, length of hospital admission, volume of poststroke care, use of antibiotics during the three-month follow-up, functional outcome using the full ordinal scoring range of the modified Rankin Scale, quality-adjusted life years and costs.