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Sex differences in the clinical and surgical management after intracerebral hemorrhage: A post hoc analysis of the INTERACT3 clinical trial
(SAGE Publications, 2026-02-05)
Ma. Ignacia Allende
;
Cheryl Carcel
;
MUÑOZ VENTURELLI, PAULA ANDREA
;
Katie Harris
;
Menglu Ouyang
<jats:sec> <jats:title>Introduction:</jats:title> <jats:p>As the management of intracerebral hemorrhage (ICH) shifts from historical inertia to more proactive, evidence-based care, ensuring sex-equitable access to best-practice stroke care is increasingly important. Data on sex differences in access to care for ICH remains limited and often conflicting. More robust evidence is required to understand where disparities may exist to inform targeted interventions.</jats:p> </jats:sec> <jats:sec> <jats:title>Aims:</jats:title> <jats:p>We aimed to determine sex differences in the clinical and surgical management of patients with acute ICH who participated in the third Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods:</jats:title> <jats:p>We performed a post hoc analysis of INTERACT3, an international stepped-wedge, cluster-randomised trial undertaken in 121 hospitals across 9 low- to middle-income countries and 1 high-income country. The trial aimed to evaluate a care bundle composed of intensive blood-pressure lowering, rapid correction of hyperglycemia, fever control, and reversal of anticoagulation; in adults presenting within 6 h of ICH onset. We used mixed-effects logistic regression to evaluate sex differences in access to surgical interventions, admission to an intensive care unit or acute stroke unit, assisted feeding, physiotherapy, occupational therapy, withdrawal of care, and use of pharmacological therapies (antiepileptic drugs, mannitol, dexamethasone, and statins). Patterns of care were further evaluated using latent class analysis, with sex differences analyzed using the same regression framework.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p>Of 7036 patients with ICH, 2533 (36%) were female. Females were older and had more severe neurological deficits. Overall care provision was similar across sexes. However, females were more likely to receive assisted feeding (odds ratio [OR] 1.15, 95% CI = 1.02–1.31), and were less likely to withdraw from active care (OR 0.41, 95% CI = 0.19–0.87) than males. Surgical interventions were accessed at similar rates among sexes, a finding that persisted in analyses restricted to supratentorial ICH with hematoma volumes ⩾ 30 mL. Three distinct care classes were identified: high-intensity, high-rehabilitation, and low-intensity, with females and males having comparable distributions within the classes.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion:</jats:title> <jats:p>Following acute ICH, females generally receive similar active acute care interventions as males, except for observed differences in access to assisted feeding and decision to withdraw from active care. These findings suggest that equal access to ICH interventions for females and males is feasible and exists in some settings. However, disparities in certain key interventions remain and present actionable opportunities for improvement. Further research is needed to explore not only access but also the timing and frequency of these interventions.</jats:p> </jats:sec> <jats:sec> <jats:title>Data access statement:</jats:title> <jats:p>Individual, de-identified participant data used in these analyses will be shared on request from any qualified investigator after the approval of a protocol and signed data access agreement via both the trial steering committee and the research office of The George Institute for Global Health (Sydney, NSW, Australia).</jats:p> </jats:sec>
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STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy (STRONGER): study protocol for a randomised, open label clinical trial in patients with persistent neurological symptoms after COVID-19 infection
(BMJ, 2025-04)
Carlos Delfino
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Cheryl Carcel
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Xiaolei Lin
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MUÑOZ VENTURELLI, PAULA ANDREA
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Sharon L Naismith
<jats:sec> <jats:title>Introduction</jats:title> <jats:p>Increasing awareness of the high frequency, wide spectrum and disabling nature of symptoms that can persist following COVID-19 infection has prompted the investigation of management strategies. Our study aims to determine the effectiveness of atorvastatin on cognitive function, physical activity, mood, health-related quality of life and features of neurovascular impairment and neuroinflammation in adults with ongoing neurological symptoms after COVID-19 infection.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and analysis</jats:title> <jats:p>The STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy study is an ongoing international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint trial with fixed time points for outcome assessments. A total of 410 participants with long covid neurological symptoms were planned to be randomly assigned to either the intervention group to receive 40 mg atorvastatin for 12 months or to a control group of no treatment, on top of usual care.</jats:p> </jats:sec> <jats:sec> <jats:title>Ethics and dissemination</jats:title> <jats:p>This study protocol was designed, implemented and reported, in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice, the National Health and Medical Research Council of Australia, the National Statement on Ethical Conduct in Human Research and with the ethical principles laid down in the World Medical Association Declaration of Helsinki. Central ethics committee approval was obtained from Sydney Local Health District Royal Prince Alfred Hospital Ethics (No: X21-0113 and 2021/ETH00777 10) in Australia. Site-specific ethics committee approvals were obtained elsewhere before any local study activities. All participants provided written informed consent.</jats:p> </jats:sec> <jats:sec> <jats:title>Trial registration number</jats:title> <jats:p>The study protocol is registered at Clinicaltrials.gov (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04904536">NCT04904536</jats:ext-link>).</jats:p> </jats:sec>
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Effects of blood pressure lowering in relation to time in acute intracerebral haemorrhage: a pooled analysis of the four INTERACT trials
(Elsevier BV, 2025-07)
Xia Wang
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Xinwen Ren
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Qiang Li
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Menglu Ouyang
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Chen Chen
Scopus© Citations 1 2
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Safety and efficacy of low-intensity versus standard monitoring following intravenous thrombolytic treatment in patients with acute ischaemic stroke (OPTIMISTmain): an international, pragmatic, stepped-wedge, cluster-randomised, controlled non-inferiority trial
(Elsevier BV, 2025-05)
Craig S Anderson
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Debbie Summers
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Menglu Ouyang
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Yi Sui
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Brenda Johnson
2Scopus© Citations 15
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The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial
(2023)
Lu Ma
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Xin Hu
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Lili Song
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Xiaoying Chen
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Menglu Ouyang
Scopus© Citations 221 1
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Validation of the simplified modified Rankin scale for stroke trials: Experience from the ENCHANTED alteplase-dose arm
(2020)
Xiaoying Chen
;
Jingwei Li
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Craig S Anderson
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Richard I Lindley
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Maree L Hackett
<jats:sec><jats:title>Background and aims</jats:title><jats:p> The structured, simplified modified Rankin scale questionnaire (smRSq) may increase reliability over the interrogative approach to scoring the modified Rankin scale (mRS) in acute stroke research and practice. During the conduct of the alteplase-dose arm of the international ENhanced Control of Hypertension ANd Thrombolysis StrokE stuDy (ENCHANTED), we had an opportunity to compare each of these approaches to outcome measurement. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Baseline demographic data were recorded together with the National Institutes of Health Stroke Scale (NIHSS). Follow-up measures obtained at 90 days included mRS, smRSq, and the 5-Dimension European Quality of life scale (EQ-5D). Agreements between smRSq and mRS were assessed with the Kappa statistic. Multiple logistic regression was used to identify baseline predictors of Day 90 smRSq and mRS scores. Treatment effects, based on Day 90 smRSq/mRS scores, were tested in logistic and ordinal logistic regression models. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> SmRSq and mRS scores had good agreement (weighted Kappa 0.79, 95% confidence interval (CI) 0.78–0.81), while variables of age, atrial fibrillation, diabetes mellitus, pre-morbid mRS (1 vs. 0), baseline NIHSS scores, and imaging signs of cerebral ischemia, similarly predicted their scores. Odds ratios for death or disability, and ordinal shift, 90-day mRS scores using smRSq were 1.05 (95% CI 0.91–1.20; one-sided P = 0.23 for non-inferiority) and 0.98 (95% CI 0.87–1.11; P = 0.02 for non-inferiority), similar to those using mRS. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> This study demonstrates the utility of the smRSq in a large, ethnically diverse clinical trial population. Scoring of the smRSq shows adequate agreement with the standard mRS, thus confirming it is a reliable, valid, and useful alternative measure of functional status after acute ischemic stroke. </jats:p></jats:sec><jats:sec><jats:title>Clinical Trial registration</jats:title><jats:p> URL: http://www.clinicaltrials.gov . Unique identifier: NCT01422616. </jats:p></jats:sec>
Scopus© Citations 9 7
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Prognostic significance of early urinary catheterization after acute stroke: Secondary analyses of the international HeadPoST trial
(2020)
Menglu Ouyang
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Laurent Billot
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Lili Song
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Xia Wang
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Christine Roffe
<jats:sec><jats:title>Background</jats:title><jats:p> 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). </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> IUC use is associated with a poor outcome after acute stroke. Further studies are required to inform appropriate use of IUC. </jats:p></jats:sec>
Scopus© Citations 4 3
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Smoking influences outcome in patients who had thrombolysed ischaemic stroke: the ENCHANTED study
(2021)
Lingli Sun
;
Lili Song
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Jie Yang
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Richard I Lindley
;
Thompson Robinson
<jats:sec><jats:title>Background and purpose</jats:title><jats:p>As studies vary in defining the prognostic significance of smoking in acute ischaemic stroke (AIS), we aimed to determine the relation of smoking and key outcomes in patient participants who had thrombolysed AIS of the international quasi-factorial randomised Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Post-hoc analyses of ENCHANTED, an international quasi-factorial randomised evaluation of intravenous alteplase-dose comparison and levels of blood pressure control in patients who had thrombolysed AIS. Multivariable logistic regression models with inverse probability of treatment weighting (IPTW) propensity scores were used to determine associations of self-reported smoking status and clinical outcomes, according to 90-day modified Rankin Scale (mRS) scores and symptomatic intracerebral haemorrhage (sICH).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 4540 patients who had an AIS, there were 1008 (22.2%) current smokers who were younger and predominantly male, with more comorbidities of hypertension, coronary artery disease, atrial fibrillation and diabetes mellitus, and greater baseline neurological impairment, compared with non-smokers. In univariate analysis, current smokers had a higher likelihood of a favourable shift in mRS scores (OR 0.88, 95% CI 0.77 to 0.99; p=0.038) but this association reversed in a fully adjusted model with IPTW (adjusted OR 1.15, 95% CI 1.04 to 1.28; p=0.009). A similar trend was also apparent for dichotomised poor outcome (mRS scores 2–6: OR 1.18, 95% CI 1.05 to 1.33; p=0.007), but not with the risk of sICH across standard criteria.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Smoking predicts poor functional recovery in patients who had thrombolysed AIS.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT01422616">NCT01422616</jats:ext-link>.</jats:p></jats:sec>
Scopus© Citations 8
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Stroke care and collaborative academic research in Latin America
(2022)
MUÑOZ VENTURELLI, PAULA ANDREA
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RECULE GONZALEZ, FRANCISCA
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Francisca Urrutia
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MAZZON AGURTO, ENRICO
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NAVIA GONZALEZ, VICTOR HUGO
<jats:p>Objective. A narrative overview of regional academic research collaborations to address the increasing burden and gaps in care for patients at risk of, and who suffer from, stroke in Latin America (LA). Materials and methods. A summary of experiences and knowledge of the local situation is presented. No systematic literature review was performed. Results. The rapidly increasing burden of stroke poses immense challenges in LA, where prevention and management strategies are highly uneven and inadequate. Clinical research is increasing through various academic consortia and networks formed to overcome structural, funding and skill barriers. However, strengthening the ability to generate, analyze and interpret randomized evidence is central to further develop effective therapies and healthcare systems in LA. Conclusions. Regional networks foster the conduct of multicenter studies –particularly randomized controlled trials–, even in resource-poor regions. They also contribute to the external validity of international studies and strengthen systems of care, clinical skills, critical thinking, and international knowledge exchange.</jats:p>
10 1Scopus© Citations 5
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Sex differences in treatment, radiological features and outcome after intracerebral haemorrhage: Pooled analysis of Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2
(2020)
Else Charlotte Sandset
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Xia Wang
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Cheryl Carcel
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Shoichiro Sato
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Candice Delcourt
<jats:sec><jats:title>Introduction</jats:title><jats:p> Reports vary on how sex influences the management and outcome from acute intracerebral haemorrhage. We aimed to quantify sex disparities in clinical characteristics, management, including response to blood pressure lowering treatment, and outcomes in patients with acute intracerebral haemorrhage, through interrogation of two large clinical trial databases. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Post-hoc pooled analysis of the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2, where patients with a hypertensive response (systolic, 150–220 mmHg) after spontaneous intracerebral haemorrhage (<6 h) were randomised to intensive (target <140 mmHg <1 h) or guideline-recommended (<180 mmHg) blood pressure lowering treatment. The interaction of sex on early haematoma growth (24 h), death or major disability (modified Rankin scale scores 3–6 at 90 days), and effect of randomised treatment were determined in multivariable logistic regression models adjusted for baseline confounding variables. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> In 3233 participants, 1191 (37%) were women who were significantly older, had higher baseline National Institutes of Health Stroke Scale scores and smaller haematoma volumes compared to men. Men had higher three-month mortality (odds ratio 1.48, 95% confidence interval 1.10–2.00); however, there was no difference between women and men in the combined endpoint of death or major disability. There were no significant sex differences on mean haematoma growth or effect of randomised blood pressure lowering treatment. </jats:p></jats:sec><jats:sec><jats:title>Discussion</jats:title><jats:p> Men included in the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials had more comorbidities, larger baseline haematoma volumes and higher mortality after adjustment for age, as compared with women. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Men included in the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials had a greater odds of dying after intracerebral haemorrhage than women, which could not be readily explained by differing casemix or patterns of blood pressure management. </jats:p></jats:sec><jats:sec><jats:title>Clinical trial registration</jats:title><jats:p> The Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials studies are registered with ClinicalTrials.gov (NCT00226096 and NCT00716079). </jats:p></jats:sec>
Scopus© Citations 15 30

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