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Impact of Ultra-Early Perioperative Antihypertensive Therapy in Acute Intracerebral Hemorrhage
(Ovid Technologies (Wolters Kluwer Health), 2026-06)
Tao Liu
;
Linan Chen
;
Leibo Liu
;
Yang Liu
;
Lu Ma
<jats:sec> <jats:title>BACKGROUND:</jats:title> <jats:p>Early intensive blood pressure (BP) lowering improves outcomes in acute intracerebral hemorrhage, but its perioperative benefit among patients undergoing surgical hematoma evacuation is uncertain. We evaluated whether earlier achievement of intensive BP targets is associated with improved outcomes in this population.</jats:p> </jats:sec> <jats:sec> <jats:title>METHODS:</jats:title> <jats:p>Post hoc secondary analysis of the INTERACT3 (the third Intensive Care Bundle With Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial) pragmatic, international, multicenter, blinded-end point, and stepped-wedge cluster-randomized trial. Among 7036 enrolled intracerebral hemorrhage patients at 121 hospitals, those who underwent surgical hematoma evacuation were included. Patients were categorized by time from hospital arrival to achieving the target systolic BP <140 mm Hg: ≤2 hours versus >2 hours. The primary outcome was 6-month mortality. Key secondary outcomes included death or disability (modified Rankin Scale scores 4–6), modified Rankin Scale score shift, health-related quality-of-life (EuroQol 5-Dimension 3-Level [EQ-5D-3L] domains, visual analog scale, and health utility index), and serious adverse events. Adjusted associations were estimated using Cox, logistic, ordinal logistic, and linear regression models, controlling for age, sex, treatment type, and admission Glasgow Coma Scale.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS:</jats:title> <jats:p> Of 7036 patients with acute intracerebral hemorrhage, 1506 underwent surgical hematoma evacuation (mean [SD] age, 59.7 [11.8] years; 33.9% women). Overall, there was no statistically significant difference in 6-month mortality between patients who achieved target BP within 2 hours of treatment initiation and those who achieved it after 2 hours (adjusted hazard ratio, 0.81 [95% CI, 0.63–1.04]; <jats:italic toggle="yes">P</jats:italic> =0.09). Early BP achievement was associated with a lower risk of death or disability (adjusted odds ratio [OR], 0.71 [95% CI, 0.56–0.90]; <jats:italic toggle="yes">P</jats:italic> =0.01), a favorable shift in the distribution of modified Rankin Scale scores (adjusted common OR, 0.73 [95% CI, 0.60–0.89]; <jats:italic toggle="yes">P</jats:italic> <0.01), and fewer serious adverse events (adjusted OR, 0.73 [95% CI, 0.57–0.94]; <jats:italic toggle="yes">P</jats:italic> =0.02). EuroQol 5-Dimension 3-Level outcomes also favored the early group, with significant improvements in mobility (adjusted OR, 0.76 [95% CI, 0.60–0.97]; <jats:italic toggle="yes">P</jats:italic> =0.03), pain/discomfort (adjusted OR, 0.72 [95% CI, 0.54–0.95]; <jats:italic toggle="yes">P</jats:italic> =0.02), and usual activities (adjusted OR, 0.79 [95% CI, 0.62–1.00]; <jats:italic toggle="yes">P</jats:italic> =0.05), as well as higher visual analog scale (mean difference, 0.08 [95% CI, 0.002–0.17]; <jats:italic toggle="yes">P</jats:italic> =0.04) and health utility scores (mean difference, 0.05 [95% CI, 0.02–0.09]; <jats:italic toggle="yes">P</jats:italic> <0.01). </jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS:</jats:title> <jats:p>In patients with intracerebral hemorrhage undergoing surgical hematoma evacuation, perioperative intensive BP reduction appears safe. Achieving systolic BP <140 mm Hg within 2 hours was associated with better functional and quality-of-life outcomes, and fewer serious adverse events. These time-sensitive associations support prioritizing ultra-early perioperative BP control; confirmatory prospective analyses are warranted.</jats:p> </jats:sec> <jats:sec> <jats:title>REGISTRATION:</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link> ; Unique identifier: NCT03209258. </jats:p> </jats:sec>
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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
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Cheryl Carcel
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MUÑOZ VENTURELLI, PAULA ANDREA
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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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Low-Intensity Monitoring for Mild-to-Moderate Acute Ischemic Stroke Is Cost Saving: Economic Evaluation for OPTIMISTmain
(Ovid Technologies (Wolters Kluwer Health), 2026-03)
Lizheng Xu
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Menglu Ouyang
;
Emily R. Atkins
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Debbie Summers
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Yi Sui
<jats:sec> <jats:title>BACKGROUND:</jats:title> <jats:p>OPTIMISTmain (Main Optimal Post rtPA-IV Monitoring in Ischemic Stroke Trial) has shown that low-intensity monitoring is feasible and safe compared with standard monitoring in stable patients who receive thrombolysis treatment for acute ischemic stroke of mild-to-moderate neurological impairment. We aimed to estimate the economic benefits of low-intensity care compared with standard care.</jats:p> </jats:sec> <jats:sec> <jats:title>METHODS:</jats:title> <jats:p>A cost-minimization analysis based on OPTIMISTmain was conducted for Australia, China, Malaysia, the United Kingdom, the United States, and Vietnam. A decision tree model comprising 2 arms was developed from the trial design. State transition probabilities for each country were extracted from the trial, and cost data were sourced from the existing literature. Mean costs over the 90-day duration of follow-up were compared, and univariate and probabilistic sensitivity and scenario analyses were performed.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS:</jats:title> <jats:p>Low-intensity monitoring had the highest probability of cost saving in China (100.00%) and the United Kingdom (100.00%), followed by Australia (99.94%), the United States (95.91%), and Vietnam (86.66%), as patients in this group incurred US dollars savings of 239, 133, 647, 943, and 3 in direct costs compared with patients in the standard group, respectively. In Malaysia, however, the intervention costs slightly exceeded those for standard care (US dollars 5643 versus 5378). Countries with higher proportions of patients having intensive care unit monitoring had greater cost savings. Cost-saving thresholds of monitoring costs were 1.24, 1.30, 1.26, 1.24, 1.01, and 0.91 times the base case value in Australia, China, the United Kingdom, the United States, Vietnam, and Malaysia, respectively.</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS:</jats:title> <jats:p>The low-intensity monitoring protocol was cost saving in countries with high proportions of intensive care resources for postthrombolysis treatment monitoring, such as in the United States.</jats:p> </jats:sec> <jats:sec> <jats:title>REGISTRATION:</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link> ; Unique identifier: NCT03734640. URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.anzctr.org.au/">https://www.anzctr.org.au/</jats:ext-link> ; Unique identifier: ACTRN 12619001556134p. </jats:p> </jats:sec>
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Mediation Analysis to Identify Individual Component Effects of the Care Bundle to Improve Functional Outcome After ICH in the INTERACT3 Study
(Ovid Technologies (Wolters Kluwer Health), 2025-10)
Xinwen Ren
;
Qiang Li
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Menglu Ouyang
;
Laurent Billot
;
Xiaoying Chen
1Scopus© Citations 6
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Surgical outcomes from haematoma evacuation for intracerebral haemorrhage in the INTERACT3 study
(Elsevier BV, 2025-09)
Xin Hu
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Menglu Ouyang
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Jianguo Xu
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Yi Liu
;
Xi Li
1Scopus© Citations 4
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Risk and impact of stroke across 38 countries and territories of the Americas from 1990 to 2021: a population-based trends analysis from the Global Burden of Disease Study 2021
(Elsevier BV, 2025-03)
Ramón Martinez
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MUÑOZ VENTURELLI, PAULA ANDREA
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Pedro Ordunez
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Felipe Fregni
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Carlos Abanto
Scopus© Citations 22 3
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Prevalence, Causal Classification, and Prognosis of Patent Foramen Ovale in Young Patients With Embolic Strokes of Undetermined Source
(Ovid Technologies (Wolters Kluwer Health), 2025-05-06)
Abhilekh Srivastava
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Kate Tsiplova
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Amanda Taylor
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Aleksandra Pikula
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Jennifer Mandzia
1
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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
;
Yi Sui
;
Brenda Johnson
2Scopus© Citations 15
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Implementation of a goal-directed Care Bundle for intracerebral hemorrhage: Results of embedded process evaluation in the INTERACT3 trial
(Public Library of Science (PLoS), 2024-12-19)
Menglu Ouyang
;
Anila Anjum
;
Francisca Gonzalez Mc Cawley
;
Mohammad Wasay
;
Lu Ma
<jats:p>The third, stepped-wedge, cluster-randomized, Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT3), has shown that a goal-directed multi-faceted Care Bundle incorporating protocols for the management of physiological variables was safe and effective for improving functional recovery in a broad range of patients with acute intracerebral hemorrhage (ICH). The INTERACT3 Care Bundle included time- and target-based protocols for the management of early intensive lowering of systolic blood pressure (SBP, target <140mmHg), glucose control (target 6.1–7.8 mmol/L in those without diabetes and 7.8–10.0 mmol/L in those with diabetes), anti-pyrexia treatment (target body temperature ≤37.5°C), and the rapid reversal of warfarin-related anticoagulation (target international normalized ratio <1.5). An embedded process evaluation was conducted to allow a better understanding of how the Care Bundle was implemented in different countries to enhance the transferability of this evidence in the international context. This study used a mixed-methods approach involving interviews, focus group discussions, and surveys to evaluate the implementation outcomes included fidelity, dose, reach, acceptability, appropriateness, adoption, and sustainability. Interviews (n = 27), focus group discussions (n = 3), and quantitative surveys (n = 48) were conducted in 7 low- and middle-income countries (LMICs) and 1 high-income country during 2019–2022. The Care Bundle was generally delivered as planned and well accepted by stakeholders, although some difficulties were reported in reaching the SBP and glycemic targets. Contextual factors including staff shortage, limited availability of antihypertensive drugs, and delayed systems of care processes, were common barriers to implementing the Care Bundle. Facilitating factors included good communication and collaboration with staff in emergency departments, the development of pathways within available resources, and regular training and monitoring. Our process evaluation provides useful insights into the contextual barriers which need to be addressed for effective scale up of the Care Bundle implementation in a global context.</jats:p> <jats:p><jats:bold>Trial registration</jats:bold>: INTERACT3 is registered at Clinicaltrials.gov (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT03209258" xlink:type="simple">NCT03209258</jats:ext-link>) and the Chinese Clinical Trial Registry (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.chictr.org.cn/showprojEN.html?proj=19647" xlink:type="simple">ChiCTR-IOC-17011787</jats:ext-link>).</jats:p>
2Scopus© Citations 3
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Predictive Accuracy of Clinicians Estimates of Death and Recovery after Acute Intracerebral Hemorrhage: Pre-Specified Analysis in INTERACT3 Study
(2024)
Menglu Ouyang
;
Lu Ma
;
Xiaoying Chen
;
Xia Wang
;
Laurent Billot
<jats:p>Introduction: Accurately predicting a patient’s prognosis is an important component of decision-making in intracerebral hemorrhage (ICH). We aimed to determine clinicians’ ability to predict survival, functional recovery, and return to premorbid activities in patients with ICH. Methods: Pre-specified secondary analysis of the third intensive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3), an international, multicenter, stepped-wedge cluster randomized controlled trial. Clinician perspectives on prognosis were collected at hospital admission and Day 7 (or before discharge). Prognosis questions were the likelihood of (i) survival at 48 h and 6 months, (ii) favorable functional outcome (recovery walking and self-care), and (iii) return to usual activities at 6 months. Clinician predictions were compared with actual outcomes. Results: Most clinician participants were from neurosurgery (75%) with a median of 8 working years (IQR 5–14) of experience. Of the 6,305 randomized patients who survived 48 h, 213 (3.4%) were predicted to die (positive predictive value [PPV] 0.99, 95% confidence interval [CI] 0.99–0.99). Of 5,435 patients who survived 6 months, 209 (3.8%) were predicted to die (PPV 0.93, 95% CI: 0.92–0.93). Predictions on the favorable functional outcome (PPV 0.54, 95% CI: 0.52–0.56) and satisfied ability to return to usual activities (PPV 0.50, 95% CI: 0.49–0.52) were poor. Prediction accuracy varied by working years and region of practice. Conclusions: In patients with ICH, clinician estimates of death are very good but conversely they are poor in predicting higher levels of functional recovery and activities. </jats:p>
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