[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659477":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":23,"studyPopulation":11,"armGroups":24,"interventions":37,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":47,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":11,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":74,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":11},{"fullName":5,"class":6},"Shengjing Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Nursing Workload",null,"From baseline to 24 hours: total time spent on post-thrombolysis nursing monitoring activities, recorded in minutes per participant.",[14],{"measure":15,"description":11,"timeFrame":16},"Missed Nursing Care","During index hospitalization, up to 7 days, using MISSCARE Survey.",{"allocation":18,"interventionModel":19,"interventionModelDescription":11,"primaryPurpose":20,"observationalModel":11,"timePerspective":11,"maskingInfo":21},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":22,"maskingDescription":11,"whoMasked":11},"NONE","Intravenous thrombolysis is an established reperfusion treatment for eligible patients with acute ischemic stroke, but post-thrombolysis monitoring is resource intensive. This study will evaluate whether a lower scheduled monitoring frequency can reduce nursing workload without causing a clinically important increase in missed nursing care or compromising clinical safety. Hospitals will be randomized in a 1:1 ratio to a low-intensity monitoring pathway or a standard-intensity monitoring pathway.",[25,31],{"label":26,"type":27,"description":28,"interventionNames":29},"Low-Intensity Monitoring","EXPERIMENTAL","Participants at assigned hospitals will receive a reduced scheduled nursing monitoring pathway during the first 24 hours after intravenous thrombolysis. Additional assessment or clinical escalation is permitted when indicated.",[30],"Procedure: lower frequency of assessment of neurological impairment and vital signs",{"label":32,"type":33,"description":34,"interventionNames":35},"Standard Monitoring","ACTIVE_COMPARATOR","Participants at assigned hospitals will receive the study standard scheduled nursing monitoring pathway during the first 24 hours after intravenous thrombolysis. Additional assessment or clinical escalation is permitted when indicated.",[36],"Procedure: standard frequency of assessment of neurological impairment and vital signs",[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"PROCEDURE","lower frequency of assessment of neurological impairment and vital signs","Participants receive neurological assessment and heart rate\u002Fblood pressure assessment every 15 minutes during the first 2 hours after initiation of thrombolytic infusion, every 2 hours during the next 8 hours, and every 4 hours during the subsequent 14 hours. Additional clinically indicated monitoring is permitted and required.",[26],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":11},"standard frequency of assessment of neurological impairment and vital signs","Participants receive neurological assessment and heart rate\u002Fblood pressure assessment every 15 minutes during the first 2 hours after initiation of thrombolytic infusion, every 30 minutes during the subsequent 6 hours, and every 60 minutes during the subsequent 16 hours. Additional clinically indicated monitoring is permitted and required.",[32],{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Anhua Wu","President of Shengjing Hospital, Director of Neurosurgery","100659477","low-intensity-monitoring-nursing-after-thrombolysis-for-acute-ischemic-stroke-100659477",false,"NCT07865598","Low-Intensity Monitoring Nursing After Thrombolysis for Acute Ischemic Stroke","Effect of Low-Intensity Monitoring Frequency After Intravenous Thrombolysis for Acute Ischemic Stroke on Nursing Workload and Missed Nursing Care: A Multicenter, Open-Label, Randomized, Blinded-Endpoint Trial","OPTINursing","Inclusion Criteria:\n\n1. Adults aged 18 years or older;\n2. diagnosis of acute ischemic stroke;\n3. treatment with intravenous alteplase, tenecteplase, or an equivalent thrombolytic agent as part of clinical care;\n4. stable vital signs with blood pressure no higher than 180\u002F105 mmHg;\n5. and mild-to-moderate neurological deficit assessed by a clinician 2 hours after thrombolysis, for example NIHSS less than 10.\n\nExclusion Criteria:\n\n1. A clear clinical contraindication to low-intensity monitoring, including need for intensive care or prolonged intensive monitoring, severe neurological deficit, early neurological deterioration or substantial risk of deterioration, need for airway support, or need for intravenous treatment unavailable on a general ward;\n2. or anticipated immediate transfer, dialysis-related transfer, palliative management, or surgery that is incompatible with adherence to the low-intensity monitoring pathway.","ALL","18 Years",{"count":62,"type":63},864,"ESTIMATED","INTERVENTIONAL",[66],"NA","This cluster-randomized study compares a lower-frequency post-thrombolysis monitoring pathway with a standard pathway in adults with acute ischemic stroke. The study evaluates nursing workload, nursing care, and clinical safety during the early post-thrombolysis period.",[69],"Stroke, Ischemic",[71,72,73],"thrombolysis","acute ischemic stroke","nursing","NOT_YET_RECRUITING","2026-10-04",{"date":77,"type":78},"2026-10-08","ACTUAL",{"date":80,"type":63},"2026-12",{"date":82,"type":63},"2028-03-31",{"name":5,"class":6}]