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  • 1
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    Head position and cerebral blood flow in acute ischemic stroke patients: Protocol for the pilot phase, cluster randomized, Head Position in Acute Ischemic Stroke Trial (HeadPoST pilot)
    SAGE Publications ; 2016
    In:  International Journal of Stroke Vol. 11, No. 2 ( 2016-02), p. 253-259
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 11, No. 2 ( 2016-02), p. 253-259
    Abstract: Few proven interventions exist for acute ischemic stroke (AIS), and most are expensive and restricted in applicability. Lying flat ‘head down’ positioning of AIS patients has been shown to increase by as much as 20%, mean cerebral blood flow velocities (CBFV) measured by transcranial Doppler (TCD) but whether this translates into clinical improvement is uncertain. Aim To determine if the lying flat position increases mean CBFV in the affected territory as compared to the sitting up position in AIS patients. Methods and design Head Position in Acute Ischemic Stroke Trial (HeadPoST pilot) is a cluster randomized (clusters being months), assessor-blinded end-point, phase IIb trial, where consecutive adults with anterior circulation AIS within 12 h of symptom onset are positioned to a randomized position for 48 h with TCD performed serially. Study outcomes Primary outcome is mean CBFV on TCD at 1 and 24 h after positioning. Secondary outcomes include: serious adverse events, neurological impairment at seven days, and death and disability at 90 days. Sample size estimates Assuming an increase of 8.3 (SD 11.4) cm/s in average of mean CBFV when tilted from 30° to 0°, 46 clusters are required (92 patients in total) to detect a 20% increase of mean CBFV with 90% power and 5% level of significance. Conclusion HeadPoST pilot is a cluster randomized multicenter clinical trial investigating the effect of head positioning on mean CBFV in anterior circulation AIS.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493015620808
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
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  • 2
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    Prophylactic heparin in acute intracerebral hemorrhage: a propensity score-matched analysis of the INTERACT2 study
    SAGE Publications ; 2016
    In:  International Journal of Stroke Vol. 11, No. 5 ( 2016-07), p. 549-556
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 11, No. 5 ( 2016-07), p. 549-556
    Abstract: Indication and timing of pharmacological venous thromboembolism prophylaxis in intracerebral hemorrhage patients is controversial. Aims To determine whether use of subcutaneous heparin during the first 7 days after spontaneous intracerebral hemorrhage increases risks of death and disability. Methods Data are from the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2) study. Patients with acute intracerebral hemorrhage ( 〈 6 hours) and elevated systolic blood pressure were included; patients received subcutaneous heparin following local best practice standards of care. Multivariable logistic regression and propensity score matched analysis were used to determine associations of heparin use on death and disability (modified Rankin scale) at 90 days. Results In 2525 patients with available data, there were 465 (22.5%) who received subcutaneous heparin. They had higher death or major disability at 90 days in crude (odds ratio 2.29, 95% confidence interval 1.85–2.84; p  〈  0.001), adjusted (odds ratio 1.62, 95% confidence interval 1.26–2.09; p  〈  0.001) and propensity score matched (odds ratio 2.06, 95% confidence interval 1.53–2.77; p  〈  0.001) analyses. In propensity score matched analysis, heparin-treated patients had significant lower mortality (odds ratio 0.55, 95% CI 0.35–0.87; p = 0.01) but greater major disability (odds ratio 1.68, 95% confidence interval 1.25–2.28; p  〈  0.001) at 90 days. However, no mortality difference was found in analysis restricted to 48-hour survivors. Conclusions Use of subcutaneous heparin is associated with poor outcome in acute intracerebral hemorrhage, driven by increased residual disability. Despite the limitations of this study, and no clear relation of heparin with bleeding risk, we recommend careful consideration of the need for venous thromboembolism prophylaxis with heparin in intracerebral hemorrhage patients. Trial registration http://www.clinicaltrials.gov NCT00716079.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493016641113
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
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  • 3
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    Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST): An international cluster cross-over randomized trial
    SAGE Publications ; 2017
    In:  International Journal of Stroke Vol. 12, No. 6 ( 2017-08), p. 667-670
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 12, No. 6 ( 2017-08), p. 667-670
    Abstract: There is evidence to indicate that the lying flat head position increases cerebral blood flow and oxygenation in patients with acute ischemic stroke, but how these physiological effects translate into clinical outcomes is uncertain. The Head Position in Stroke Trial aims to determine the comparative effectiveness of lying flat (0°) compared to sitting up (≥30°) head positioning, initiated within 24 h of hospital admission for patients with acute stroke. Design An international, pragmatic, cluster-randomized, crossover, open, blinded outcome assessed clinical trial. Each hospital with an established acute stroke unit (cluster) site was required to recruit up to 140 consecutive cases of acute stroke (one phase of head positioning before immediately crossing over to the other phase of head positioning), including both acute ischemic stroke and intracerebral hemorrhage, in each randomized head position as a ‘business as usual’ policy. Objective To outline in detail the predetermined statistical analysis plan for the study. Methods All accumulated data will be reviewed and formally assessed. Information regarding baseline characteristics of patients, their process of care and management will be outlined, and for each item, statistically relevant descriptive elements will be described. For the trial outcomes, the most appropriate statistical comparisons are described. Results A statistical analysis plan was developed that is transparent, verifiable, and predetermined before completion of data collection. Conclusions We developed a predetermined statistical analysis plan for Head Position in Stroke Trial to avoid analysis bias arising from prior knowledge of the findings, in order to reliably quantify the benefits and harms of lying flat versus sitting up early after the onset of acute stroke. Trial registration ClinicalTrials.gov identifier NCT02162017; ANZCTR identifier ACTRN12614000483651
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493017701943
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2017
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  • 4
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    Dysphagia screening and risks of pneumonia and adverse outcomes after acute stroke: An international multicenter study
    SAGE Publications ; 2020
    In:  International Journal of Stroke Vol. 15, No. 2 ( 2020-02), p. 206-215
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 15, No. 2 ( 2020-02), p. 206-215
    Abstract: Dysphagia is associated with aspiration pneumonia after stroke. Data are limited on the influences of dysphagia screen and assessment in clinical practice. Aims To determine associations between a “brief” screen and “detailed” assessment of dysphagia on clinical outcomes in acute stroke patients. Methods A prospective cohort study analyzed retrospectively using data from a multicenter, cluster cross-over, randomized controlled trial (Head Positioning in Acute Stroke Trial [HeadPoST]) from 114 hospitals in nine countries. HeadPoST included 11,093 acute stroke patients randomized to lying-flat or sitting-up head positioning. Herein, we report predefined secondary analyses of the association of dysphagia screening and assessment and clinical outcomes of pneumonia and death or disability (modified Rankin scale 3–6) at 90 days. Results Overall, 8784 (79.2%) and 3917 (35.3%) patients were screened and assessed for dysphagia, respectively, but the frequency and timing for each varied widely across regions. Neither use of a screen nor an assessment for dysphagia was associated with the outcomes, but their results were compared to “screen-pass” patients, those who failed had higher risks of pneumonia (adjusted odds ratio [aOR] = 3.00, 95% confidence interval [CI]  = 2.18–4.10) and death or disability (aOR = 1.66, 95% CI = 1.41–1.95). Similar results were evidence for the results of an assessment for dysphagia. Subsequent feeding restrictions were related to higher risk of pneumonia in patients failed dysphagia screen or assessment (aOR = 4.06, 95% CI = 1.72–9.54). Conclusions Failing a dysphagia screen is associated with increased risks of pneumonia and poor clinical outcome after acute stroke. Further studies concentrate on determining the effective subsequent feeding actions are needed to improve patient outcomes.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493019858778
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
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  • 5
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    Association between spontaneous internal carotid artery dissection and perivascular adipose tissue attenuation on computed tomography angiography
    SAGE Publications ; 2023
    In:  International Journal of Stroke Vol. 18, No. 7 ( 2023-08), p. 829-838
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 18, No. 7 ( 2023-08), p. 829-838
    Abstract: Spontaneous cervical artery dissection (sCAD) is a leading cause of ischemic stroke in young patients. Studies using high-resolution magnetic resonance imaging and positron emission tomography have suggested vessel wall inflammation to be a pathogenic factor in sCAD. Computed tomography (CT) attenuation of perivascular adipose tissue (PVAT) is an established non-invasive imaging biomarker of inflammation in coronary arteries, with higher attenuation values reflecting a greater degree of vascular inflammation. Objectives: We evaluate the CT attenuation of PVAT surrounding the internal carotid artery (PVAT carotid ) with and without spontaneous dissection. Methods: Single-center prospective observational study of 56 consecutive patients with CT-verified spontaneous dissection of the internal carotid artery (ICA). Of these patients, six underwent follow-up computed tomography angiography (CTA). Twenty-two patients who underwent CTA for acute neurological symptoms but did not have dissection formed the control group. Using semi-automated research software, PVAT carotid was measured as the mean Hounsfield unit (HU) attenuation of adipose tissue within a defined volume of interest surrounding the ICA. Results: PVAT carotid was significantly higher around dissected ICA compared with non-dissected contralateral ICA in the same patients (−58.7 ± 10.2 vs −68.9 ± 8.1 HU, p  〈  0.0001) and ICA of patients without dissection (−58.7 ± 10.2 vs −69.3 ± 9.3 HU, p  〈  0.0001). After a median follow-up of 89 days, there was a significant reduction in PVAT carotid around dissected ICA (−57.5 ± 13.4 to −74.3 ± 10.5 HU, p  〈  0.05), while no change was observed around non-dissected contralateral ICA (−71.0 ± 4.4 to −74.1 ± 4.1 HU, p = 0.19). ICA dissection was an independent predictor of PVAT carotid following multivariable adjustment for age and the presence of ICA occlusion. Conclusion: PVAT carotid is elevated in the presence of sCAD and may decrease following the acute event.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/17474930231158538
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
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  • 6
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    Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot)
    SAGE Publications ; 2017
    In:  International Journal of Stroke Vol. 12, No. 2 ( 2017-02), p. 211-215
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 12, No. 2 ( 2017-02), p. 211-215
    Abstract: The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. A feature of this trial was that patients were randomized to a certain position according to the month of admission to hospital. Objective To outline in detail the predetermined statistical analysis plan for HEADPOST Pilot study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be classified, and for each item, appropriate descriptive statistical analyses are planned with comparisons made between randomized groups. For the outcomes, statistical comparisons to be made between groups are planned and described. Results This statistical analysis plan was developed for the analysis of the results of the HEADPOST Pilot study to be transparent, available, verifiable, and predetermined before data lock. Conclusions We have developed a statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. Trial registration The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493016674955
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2017
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  • 7
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    Prognostic significance of early urinary catheterization after acute stroke: Secondary analyses of the international HeadPoST trial
    SAGE Publications ; 2021
    In:  International Journal of Stroke Vol. 16, No. 2 ( 2021-02), p. 200-206
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 16, No. 2 ( 2021-02), p. 200-206
    Abstract: An indwelling urinary catheter (IUC) is often inserted to manage bladder dysfunction, but its impact on prognosis is uncertain. We aimed to determine the association of IUC use on clinical outcomes after acute stroke in the international, multi-center, cluster crossover, Head Positioning in Acute Stroke Trial (HeadPoST). Methods Data were analyzed on HeadPoST participants (n = 11,093) randomly allocated to the lying-flat or sitting-up head position. Binomial, logistic regression, hierarchical mixed models were used to determine associations of early insertion of IUC within seven days post-randomization and outcomes of death or disability (defined as “poor outcome,” scores 3–6 on the modified Rankin scale) and any urinary tract infection at 90 days with adjustment of baseline and post-randomization management covariates. Results Overall, 1167 (12%) patients had an IUC, but the frequency and duration of use varied widely across patients in different regions. IUC use was more frequent in older patients, and those with vascular comorbidity, greater initial neurological impairment (on the National Institutes of Health Stroke Scale), and intracerebral hemorrhage as the underlying stroke type. IUC use was independently associated with poor outcome (adjusted odds ratio (aOR): 1.40, 95% confidence interval (CI): 1.13–1.74), but not with urinary tract infection after adjustment for antibiotic treatment and stroke severity at hospital separation (aOR: 1.13, 95% CI: 0.59–2.18). The number exposed to IUC for poor outcome was 13. Conclusions IUC use is associated with a poor outcome after acute stroke. Further studies are required to inform appropriate use of IUC.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493020908140
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
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  • 8
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    Flat-head positioning increases cerebral blood flow in anterior circulation acute ischemic stroke. A cluster randomized phase IIb trial
    SAGE Publications ; 2018
    In:  International Journal of Stroke Vol. 13, No. 6 ( 2018-08), p. 600-611
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 13, No. 6 ( 2018-08), p. 600-611
    Abstract: Whether lying-flat improves blood flow in patients with acute ischemic stroke is unknown. Our aim was to investigate if lying-flat “changes” cerebral blood flow velocities assessed by transcranial Doppler in acute ischemic stroke patients. Methods In a multicenter cluster clinical trial, we randomly assigned patients within 12 h from onset of a neurological deficit due to cerebral ischemia of the anterior circulation to lying-flat or upright head positioning. The primary outcome was a change of 8 cm/s or more in mean cerebral blood flow velocities on transcranial Doppler to the middle cerebral artery at 1 and 24 h post-randomization, adjusted for imbalance in baseline variables. Secondary outcomes included serious adverse events and physical functioning at 90 days. Results Ninety-four of 304 patients screened were recruited. The primary outcome occurred in 11 (26%) of 43 patients in the lying-flat group and in 6 (12%) of 51 in the upright group at 1 h (adjusted odds ratio, 3.81; 95% CI, 1.07 to 13.54), and in 23 (53%) and 18 (36%) patients in these respective groups at 24 h (adjusted odds ratio, 3.04; 95% CI, 1.08 to 8.53). There were no between-group differences in serious adverse events, including pneumonia, heart failure or mortality, nor in functional outcome at 3 months (adjusted common odds ratio, 1.38; 95% CI 0.64 to 3.00). Conclusion The lying-flat head position was associated with a significant increase in cerebral blood flow velocities at one and 24 h within the ipsilateral hemisphere of anterior circulation acute ischemic stroke, without serious safety concerns. Clinical trial registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT01706094.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493017711943
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2018
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  • 9
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    Stroke in Latin America: Systematic review of incidence, prevalence, and case-fatality in 1997–2021
    SAGE Publications ; 2023
    In:  International Journal of Stroke Vol. 18, No. 6 ( 2023-07), p. 645-656
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 18, No. 6 ( 2023-07), p. 645-656
    Abstract: Stroke is a major global cause of death and disability. Most strokes occur in populations of low-middle-income country (LMIC); therefore, the subsequent disease burden is greater than in populations of high-income countries. Few epidemiological data exist for stroke in Latin America, composed primarily of LMIC. Aims: To determine epidemiological measures of incidence, prevalence, and 1-month case-fatality for stroke in Latin America/Caribbean (LAC) during 1997–2021. Summary of review: A structured search was conducted to identify relevant references from MEDLINE, WOS, and LILACS databases for prospective observational and cross-sectional studies in LAC populations from January 1997 to December 2021. A total of 9242 records were screened and 12 selected for analysis, seven incidence studies and five prevalence studies. Case-fatality was reported in six articles. Sub-group analysis by age, sex, and income countries was performed. A narrative synthesis of the findings was performed. Meta-analysis was performed using random-effect model to obtain pooled estimates with 95% confidence intervals (CIs). Studies quality was assessed according to the risk of bias criteria described in the Joanna Briggs Institute’s guide. The overall crude annual incidence rate of first-ever stroke in LAC was 119.0 (95% CI = 95.9–142.1)/100,000 people (with high heterogeneity between studies ( I 2  = 98.1%)). The overall crude prevalence was 3060 (95% CI: 95.9–142.1)/100,000 people (with high heterogeneity between studies ( I 2  = 98.8%)). The overall case-fatality at 1 month after the first stroke was 21.1% (95% CI = 18.6–23.7) ( I 2  = 49.40%). Conclusion: This review contributes to our understanding regarding the burden caused by stroke in LAC. More studies with comparable designs are needed to generate reliable data and should include both standardized criteria, such as the World Health Organization clinical criteria and updated standard methods of case assurance, data collection, and reporting.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/17474930221143323
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
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