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1.
Stroke Vasc Neurol ; 7(2): 158-165, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1832554

ABSTRACT

RATIONALE: Haematoma growth is common early after intracerebral haemorrhage (ICH), and is a key determinant of outcome. Tranexamic acid, a widely available antifibrinolytic agent with an excellent safety profile, may reduce haematoma growth. METHODS AND DESIGN: Stopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units (STOP-MSU) is a phase II double-blind, randomised, placebo-controlled, multicentre, international investigator-led clinical trial, conducted within the estimand statistical framework. HYPOTHESIS: In patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo. SAMPLE SIZE ESTIMATES: A sample size of 180 patients (90 in each arm) would be required to detect an absolute difference in the primary outcome of 20% (placebo 39% vs treatment 19%) under a two-tailed significance level of 0.05. An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients. INTERVENTION: Participants will receive 1 g intravenous tranexamic acid over 10 min, followed by 1 g intravenous tranexamic acid over 8 hours; or matching placebo. PRIMARY EFFICACY MEASURE: The primary efficacy measure is the proportion of patients with haematoma growth by 24±6 hours, defined as either ≥33% relative increase or ≥6 mL absolute increase in haematoma volume between baseline and follow-up CT scan. DISCUSSION: We describe the rationale and protocol of STOP-MSU, a phase II trial of tranexamic acid in patients with ICH within 2 hours from onset, based in participating mobile stroke units and emergency departments.


Subject(s)
Antifibrinolytic Agents , Stroke , Tranexamic Acid , Antifibrinolytic Agents/adverse effects , Cerebral Hemorrhage/chemically induced , Cerebral Hemorrhage/diagnostic imaging , Cerebral Hemorrhage/drug therapy , Clinical Trials, Phase II as Topic , Hematoma/chemically induced , Hematoma/drug therapy , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Stroke/therapy , Tranexamic Acid/adverse effects
2.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-305816

ABSTRACT

Background: To provide an overview of the worldwide association between hospital beds, the burden of non-communicable diseases (NCDs), and COVID-19 mortality. Methods: : Data was extracted regarding COVID-19 deaths and cases from the Our World in Data as of March 23, 2021. The following data was obtained:1) NCDs disability-adjusted life years (DALYs), health-adjusted life expectancy, and the health access and quality index from the Global Burden of Disease study;2) the number of hospital beds, physicians, nurses and midwives per population, and out-of-pocket payments from the WHO website. Using the multilevel generalized linear model, these variables’ independent associations with COVID-19 mortality rate ratio (MRR) was examined. Results: : Hospital beds were associated with reduced COVID-19 mortality (MRR=0.47;95% CI: 0.44 to 0.5) globally. During COVID-19 peak periods, despite a decreasing trend in COVID-19 MRR with increasing beds in high-income countries, the odds of mortality remained high even within the highest percentile of hospital beds (MRR=1.54 for 20 th -40 th and 1.06 for >60 th bed percentile, respectively). On the contrary, in middle-income countries, an inverse association was observed between the number of hospital beds and COVID-19 mortality in both periods. NCD DALYs were associated with increased COVID-19 deaths, particularly during peak mortality periods in high-income countries. Death-to-case ratio increased by approximately two times during the peak vs non-peak mortality periods. Conclusions: : COVID-19 is a syndemic interacting with non-communicable diseases and not only a pandemic. A comprehensive national healthcare plan against COVID-19 spread should include adequate measures to protect vulnerable patients with pre-existing chronic conditions.

3.
Stroke ; 52(11): 3739-3747, 2021 11.
Article in English | MEDLINE | ID: covidwho-1443690

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic has presented unique challenges to stroke care and research internationally. In particular, clinical trials in stroke are vulnerable to the impacts of the pandemic at multiple stages, including design, recruitment, intervention, follow-up, and interpretation of outcomes. A carefully considered approach is required to ensure the appropriate conduct of stroke trials during the pandemic and to maintain patient and participant safety. This has been recently addressed by the International Council for Harmonisation which, in November 2019, released an addendum to the Statistical Principles for Clinical Trials guidelines entitled Estimands and Sensitivity Analysis in Clinical Trials. In this article, we present the International Council for Harmonisation estimand framework for the design and conduct of clinical trials, with a specific focus on its application to stroke clinical trials. This framework aims to align the clinical and scientific objectives of a trial with its design and end points. It also encourages the prospective consideration of potential postrandomization intercurrent events which may occur during a trial and either impact the ability to measure an end point or its interpretation. We describe the different categories of such events and the proposed strategies for dealing with them, specifically focusing on the COVID-19 pandemic as a source of intercurrent events. We also describe potential practical impacts posed by the COVID-19 pandemic on trials, health systems, study groups, and participants, all of which should be carefully reviewed by investigators to ensure an adequate practical and statistical strategy is in place to protect trial integrity. We provide examples of the implementation of the estimand framework within hypothetical stroke trials in intracerebral hemorrhage and stroke recovery. While the focus of this article is on COVID-19 impacts, the strategies and principles proposed are well suited for other potential events or issues, which may impact clinical trials in the field of stroke.


Subject(s)
COVID-19 , Clinical Trials as Topic/methods , Data Interpretation, Statistical , Research Design , Stroke/therapy , Clinical Trials as Topic/standards , Guidelines as Topic , Humans , Implementation Science , SARS-CoV-2
4.
J Stroke Cerebrovasc Dis ; 30(12): 106121, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1415617

ABSTRACT

BACKGROUND: There is little information regarding the safety of intravenous tissue plasminogen activator (IV-tPA) in patients with stroke and COVID-19. METHODS: This multicenter study included consecutive stroke patients with and without COVID-19 treated with IV-tPA between February 18, 2019, to December 31, 2020, at 9 centers participating in the CASCADE initiative. Clinical outcomes included modified Rankin Scale (mRS) at hospital discharge, in-hospital mortality, the rate of hemorrhagic transformation. Using Bayesian multiple regression and after adjusting for variables with significant value in univariable analysis, we reported the posterior adjusted odds ratio (OR, with 95% Credible Intervals [CrI]) of the main outcomes. RESULTS: A total of 545 stroke patients, including 101 patients with COVID-19 were evaluated. Patients with COVID-19 had a more severe stroke at admission. In the study cohort, 85 (15.9%) patients had a hemorrhagic transformation, and 72 (13.1%) died in the hospital. After adjustment for confounding variables, discharge mRS score ≥2 (OR: 0.73, 95% CrI: 0.16, 3.05), in-hospital mortality (OR: 2.06, 95% CrI: 0.76, 5.53), and hemorrhagic transformation (OR: 1.514, 95% CrI: 0.66, 3.31) were similar in COVID-19 and non COVID-19 patients. High-sensitivity C reactive protein level was a predictor of hemorrhagic transformation in all cases (OR:1.01, 95%CI: 1.0026, 1.018), including those with COVID-19 (OR:1.024, 95%CI:1.002, 1.054). CONCLUSION: IV-tPA treatment in patients with acute ischemic stroke and COVID-19 was not associated with an increased risk of disability, mortality, and hemorrhagic transformation compared to those without COVID-19. IV-tPA should continue to be considered as the standard of care in patients with hyper acute stroke and COVID-19.


Subject(s)
COVID-19/complications , Fibrinolytic Agents/administration & dosage , Ischemic Stroke/drug therapy , Thrombolytic Therapy , Aged , Aged, 80 and over , COVID-19/diagnosis , COVID-19/mortality , Disability Evaluation , Europe , Female , Fibrinolytic Agents/adverse effects , Hospital Mortality , Humans , Infusions, Intravenous , Intracranial Hemorrhages/chemically induced , Iran , Ischemic Stroke/complications , Ischemic Stroke/diagnosis , Ischemic Stroke/mortality , Male , Middle Aged , Risk Assessment , Risk Factors , Thrombolytic Therapy/adverse effects , Thrombolytic Therapy/mortality , Time Factors , Treatment Outcome
6.
J Stroke Cerebrovasc Dis ; 29(12): 105321, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-872317

ABSTRACT

BACKGROUND: The emergence of the COVID-19 pandemic has significantly impacted global healthcare systems and this may affect stroke care and outcomes. This study examines the changes in stroke epidemiology and care during the COVID-19 pandemic in Zanjan Province, Iran. METHODS: This study is part of the CASCADE international initiative. From February 18, 2019, to July 18, 2020, we followed ischemic and hemorrhagic stroke hospitalization rates and outcomes in Valiasr Hospital, Zanjan, Iran. We used a Bayesian hierarchical model and an interrupted time series analysis (ITS) to identify changes in stroke hospitalization rate, baseline stroke severity [measured by the National Institutes of Health Stroke Scale (NIHSS)], disability [measured by the modified Rankin Scale (mRS)], presentation time (last seen normal to hospital presentation), thrombolytic therapy rate, median door-to-needle time, length of hospital stay, and in-hospital mortality. We compared in-hospital mortality between study periods using Cox-regression model. RESULTS: During the study period, 1,026 stroke patients were hospitalized. Stroke hospitalization rates per 100,000 population decreased from 68.09 before the pandemic to 44.50 during the pandemic, with a significant decline in both Bayesian [Beta: -1.034; Standard Error (SE): 0.22, 95% CrI: -1.48, -0.59] and ITS analysis (estimate: -1.03, SE = 0.24, p < 0.0001). Furthermore, we observed lower admission rates for patients with mild (NIHSS < 5) ischemic stroke (p < 0.0001). Although, the presentation time and door-to-needle time did not change during the pandemic, a lower proportion of patients received thrombolysis (-10.1%; p = 0.004). We did not see significant changes in admission rate to the stroke unit and in-hospital mortality rate; however, disability at discharge increased (p < 0.0001). CONCLUSION: In Zanjan, Iran, the COVID-19 pandemic has significantly impacted stroke outcomes and altered the delivery of stroke care. Observed lower admission rates for milder stroke may possibly be due to fear of exposure related to COVID-19. The decrease in patients treated with thrombolysis and the increased disability at discharge may indicate changes in the delivery of stroke care and increased pressure on existing stroke acute and subacute services. The results of this research will contribute to a similar analysis of the larger CASCADE dataset in order to confirm findings at a global scale and improve measures to ensure the best quality of care for stroke patients during the COVID-19 pandemic.


Subject(s)
Brain Ischemia/therapy , COVID-19 , Hospitalization/trends , Intracranial Hemorrhages/therapy , Outcome and Process Assessment, Health Care/trends , Stroke/therapy , Thrombolytic Therapy/trends , Time-to-Treatment/trends , Aged , Aged, 80 and over , Bayes Theorem , Brain Ischemia/diagnosis , Brain Ischemia/mortality , COVID-19/epidemiology , Female , Hospital Mortality/trends , Humans , Interrupted Time Series Analysis , Intracranial Hemorrhages/diagnosis , Intracranial Hemorrhages/mortality , Iran/epidemiology , Length of Stay/trends , Male , Middle Aged , Recovery of Function , Stroke/diagnosis , Stroke/mortality , Time Factors , Treatment Outcome
7.
J Neurol Sci ; 416: 117013, 2020 09 15.
Article in English | MEDLINE | ID: covidwho-629733

ABSTRACT

INTRODUCTION: Current evidence on the association between COVID-19 and dementia is sparse. This study aims to investigate the associations between COVID-19 caseload and the burden of dementia. METHODS: We gathered data regarding burden of dementia (disability-adjusted life years [DALYs] per 100,000), life expectancy, and healthy life expectancy (HALE) from the Global Burden of Disease (GBD) 2017 study. We obtained COVID-19 data from Our World in Data database. We analyzed the association of COVID-19 cases and deaths with the burden of dementia using Spearman's rank correlation coefficient. RESULTS: Globally, we found significant positive (p < .001) correlations between life expectancy (r = 0.60), HALE (r = 0.58), and dementia DALYs (r = 0.46) with COVID-19 caseloads. Likewise, we found similar correlations between life expectancy (r = 0.60), HALE (r = 0.58) and dementia DALYs (r = 0.54) with COVID-19 mortality. CONCLUSION: Health policymakers should clarify a targeted model of disease surveillance in order to reduce the dual burden of dementia and COVID-19.


Subject(s)
COVID-19/epidemiology , Dementia/epidemiology , Age Distribution , Cause of Death , Comorbidity , Databases, Factual , Global Burden of Disease , Humans , Pandemics
8.
J Stroke Cerebrovasc Dis ; 29(9): 105089, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-614222

ABSTRACT

BACKGROUND: The interaction between coronavirus disease 2019 (COVID-19) and non-communicable diseases may increase the global burden of disease. We assessed the association of COVID-19 with ageing and non-communicable diseases. METHODS: We extracted data regarding non-communicable disease, particularly cardiovascular disease, deaths, disability-adjusted life years (DALYs), and healthy life expectancy (HALE) from the Global Burden of Disease Study (GBD) 2017. We obtained data of confirmed COVID-19 cases, deaths, and tests from the Our World in Data database as of May 28, 2020. Potential confounders of pandemic outcomes analyzed include institutional lockdown delay, hemispheric geographical location, and number of tourists. We compared all countries according to GBD classification and World Bank income level. We assessed the correlation between independent variables associated with COVID-19 caseload and mortality using Spearman's rank correlation and adjusted mixed model analysis. FINDINGS: High-income had the highest, and the Southeast Asia, East Asia, and Oceania region had the least cases per million population (3050.60 vs. 63.86). Sub-saharan region has reported the lowest number of COVID-19 mortality (1.9). Median delay to lockdown initiation varied from one day following the first case in Latin America and Caribbean region, to 34 days in Southeast Asia, East Asia, and Oceania. Globally, non-communicable disease DALYs were correlated with COVID-19 cases (r = 0.32, p<0.001) and deaths (r = 0.37, p<0.001). HALE correlated with COVID-19 cases (r = 0.63, p<0.001) and deaths (r = 0.61, p<0.001). HALE was independently associated with COVID-19 case rate and the number of tourists was associated with COVID-19 mortality in the adjusted model. INTERPRETATION: Preventive measures against COVID-19 should protect the public from the dual burden of communicable and non-communicable diseases, particularly in the elderly. In addition to active COVID-19 surveillance, policymakers should utilize this evidence as a guide for prevention and coordination of health services. This model is timely, as many countries have begun to reduce social isolation.


Subject(s)
Coronavirus Infections/epidemiology , Global Health , Noncommunicable Diseases/epidemiology , Pneumonia, Viral/epidemiology , Age Factors , Aged , Aged, 80 and over , Betacoronavirus/pathogenicity , COVID-19 , Cause of Death , Coronavirus Infections/mortality , Coronavirus Infections/prevention & control , Coronavirus Infections/virology , Cost of Illness , Databases, Factual , Female , Health Services Needs and Demand , Health Status Disparities , Healthcare Disparities , Host-Pathogen Interactions , Humans , Incidence , Infection Control , Male , Middle Aged , Needs Assessment , Noncommunicable Diseases/mortality , Noncommunicable Diseases/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/mortality , Pneumonia, Viral/prevention & control , Pneumonia, Viral/virology , Prognosis , Risk Factors , SARS-CoV-2 , Time Factors
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