A groundbreaking international study has demonstrated that monitoring vital signs and neurological function at half the frequency traditionally recommended for low-risk patients after acute ischaemic stroke does not compromise the quality of care or patient recovery. Presented at the 11th European Stroke Organisation Conference held in Helsinki, this finding challenges decades-old clinical guidelines, potentially revolutionizing post-stroke management in intensive care units (ICUs) worldwide.
The research, known as the Optimal Post rTpa-Iv Monitoring in Ischaemic Stroke Trial (OPTIMISTmain), is a large-scale, pragmatic, stepped-wedge, cluster-randomised controlled non-inferiority trial involving 4,515 patients across eight countries. Published simultaneously in The Lancet, the study targeted patients who underwent intravenous thrombolytic therapy, a time-sensitive “clot-busting” treatment critical for restoring cerebral blood flow. Its design specifically investigates whether a reduction in the intensity of post-thrombolysis monitoring—thus minimizing nursing interventions—could maintain safety and efficacy.
Historically, monitoring protocols developed in the 1990s have dictated frequent neurological and vital sign assessments for 24 hours following thrombolytic treatment, often requiring upwards of 39 checks during this period. These rigorous standards, whilst intended to promptly identify complications such as intracerebral haemorrhage, place significant demands on healthcare resources, particularly nursing time and ICU bed availability. This study’s novel approach proposes a low-intensity monitoring alternative, reducing assessments to 19 over the same timeframe, and examines its impact on patient outcomes and system efficiency.
During the initial critical two hours post-thrombolysis, all patients—regardless of group—received assessments every 15 minutes. Following this, the low-intensity group was monitored every two hours over the next eight hours, then every four hours until 24 hours. In contrast, the standard monitoring group underwent evaluations every 30 minutes for eight hours, followed by hourly checks thereafter. This staggered reduction in observation frequency was carefully devised with patient safety as the utmost priority.
The trial’s endpoints centered around major clinical outcomes, including death or disability at 90 days, incidence of intracerebral haemorrhage, and serious adverse events. Remarkably, findings revealed near-identical rates of poor functional outcomes—31.7% in the low-intensity cohort versus 30.9% in the standard group—providing compelling evidence that halving monitoring frequency does not negatively affect recovery trajectories in low-risk patients.
Equally notable were the complications rates. Intracerebral haemorrhage, the most severe side effect linked to thrombolysis, was exceedingly rare, occurring in only 0.2% of the low-intensity group compared to 0.4% of the standard group. Serious adverse events were also statistically comparable, documented at roughly 11% across both arms. These data systematically debunk fears that reduced surveillance compromises patient safety.
The implications extend beyond clinical outcomes. Lead researcher Professor Craig Anderson from The George Institute for Global Health explained that traditional protocols monopolize nursing attention. This intensive labor limits the capacity of healthcare professionals to engage in essential complementary care, such as patient education, psychological support, and family counselling — elements crucial to comprehensive stroke rehabilitation. Lowering monitoring frequency effectively liberates nursing resources to holistically improve patient experience.
Moreover, hospitals implementing the low-intensity strategy observed increased ICU bed availability, thereby enhancing healthcare system resilience, notably in countries with constrained resources. In the United States, this translated to a 30% reduction in stroke patient ICU admissions, mitigating pressures on critical care infrastructure, which have been exacerbated during the COVID-19 pandemic and continue due to persistent staffing shortages.
Professor Victor C. Urrutia, Medical Director of the Comprehensive Stroke Center at Johns Hopkins Hospital and senior author of the trial, underscored the broader significance: “Our study offers a blueprint for sustainable stroke care delivery amidst ongoing healthcare strains. By optimizing monitoring intensity, we can preserve bed capacity and nursing workforce vitality without sacrificing patient outcomes.”
Stroke remains a global health crisis, ranking as the second leading cause of mortality and the third most frequent cause of disability worldwide. Acute ischaemic stroke—stemming from obstructed cerebral blood vessels due to thrombotic clots—makes up approximately 65% of stroke cases globally. Yet, a substantial subset of these patients are classified as low risk based on neurological impairment scale scores and clinical stability, identifying them as ideal candidates for less intensive monitoring regimes.
The OPTIMISTmain trial was intentionally designed to include diverse geographic and economic contexts. Participating centers spanned four high-income nations—Australia, Chile, the United Kingdom, and the United States—and four middle to low-income countries, including China, Malaysia, Mexico, and Vietnam. This breadth ensures the applicability of findings across varied healthcare systems and resource constraints.
Given the trial’s rigorous methodology—including its pragmatic, stepped-wedge design—it represents a pivotal advancement in evidence-based stroke care. Stepped-wedge randomization allowed staggered implementation of the low-intensity protocol across sites, optimizing both ethical considerations and real-world feasibility while preserving statistical power to confirm non-inferiority.
As healthcare systems globally seek to optimize patient outcomes amidst escalating demand and dwindling resources, this study’s findings could prompt an urgent reevaluation of entrenched clinical guidelines. It signals a shift towards precision in post-thrombolysis monitoring, aligning intensity with individual patient risk and hospital capabilities rather than adhering to inflexible standards.
Future work will likely explore complementary strategies to augment stroke care, such as integrating telemonitoring and artificial intelligence to identify early signs of deterioration with minimal frontline staff engagement. However, for now, the OPTIMISTmain trial provides robust, actionable evidence supporting a less intrusive, patient-centered approach that preserves safety while enhancing healthcare delivery.
In summary, halving the frequency of post-thrombolysis monitoring in low-risk acute ischaemic stroke patients is demonstrated to be just as safe and effective as conventional high-frequency protocols. Aside from maintaining equivalent clinical outcomes, this reduction conserves critical nursing resources, alleviates ICU occupancy pressures, and enhances the overall quality of care — a timely breakthrough poised to influence international stroke treatment standards and benefit patients worldwide.
Subject of Research: People
Article Title: 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
News Publication Date: 21-May-2025
Web References:
http://dx.doi.org/10.1016/S0140-6736(25)00549-5
References:
Anderson CS et al. The main Optimal Post rTpa-Iv Monitoring in Ischaemic Stroke Trial (OPTIMISTmain): an international, pragmatic, stepped wedge, cluster randomised, controlled non-inferiority trial. The Lancet, 2025.
Feigin VL et al. Global, regional, and national burden of stroke and its risk factors, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Neurology, 2024.
Walter K. What is acute ischemic stroke? JAMA, 2022.
Man S et al. Association between thrombolytic door-to-needle time and 1-year mortality and readmission in patients with acute ischemic stroke. JAMA, 2020.
Keywords:
Cerebrovascular disorders, Health care delivery, Vital signs, Thrombosis, Brain ischemia, Health care costs
Tags: clinical trial findingshealthcare resource optimizationintensive care unit protocolsinternational stroke research studyischaemic stroke treatment innovationslow-risk stroke patient careneurological function assessmentnursing intervention reductionpatient safety in stroke carepost-stroke management practicesstroke monitoring guidelinesthrombolytic therapy monitoring
