Fatal and non-fatal events within 14 days after early, intensive mobilization post stroke

Objective: We examined fatal and non-fatal Serious Adverse Events (SAEs) at 14 days within AVERT. Method: A prospective, parallel group, assessor blinded, randomized international clinical trial comparing very early intensive mobilization training (VEM) with usual care (UC); with follow up to 3 months. Included: Patients with ischaemic and haemorrhagic stroke within 24 hours of onset and physiological parameters within set limits. Treatment with thrombolytics allowed. Excluded: Patients with severe premorbid disability and/or comorbidities. Interventions continued for 14 days or hospital discharge if less. The primary early safety outcome was fatal SAEs within 14 days. Secondary outcomes were non-fatal SAEs classified as neurological, immobility-related, and other. Mortality influences were assessed using binary logistic regression adjusted for baseline stroke severity (NIHSS) and age. Results: 2104 participants were randomized to VEM (n=1054) or UC (n=1050) with a median age of 7...研究目标：本研究针对AVERT试验中14天内发生的致命与非致命严重不良事件（Serious Adverse Events, SAEs）开展分析。 研究方法：本研究为一项前瞻性、平行对照、评估者设盲的随机化国际临床试验，对比极早期强化活动训练（Very Early Intensive Mobilization, VEM）与常规护理（Usual Care, UC），随访周期至3个月。 纳入标准：发病24小时内确诊缺血性卒中与出血性卒中，且生理参数处于预设限值内的患者；允许接受溶栓治疗。 排除标准：存在严重病前残疾和/或合并症的患者。 干预方案持续14天，若患者住院时长不足14天则干预至出院当日。 本次研究的早期安全性主要结局为14天内发生的致命性SAEs；次要结局为按神经科相关、活动受限相关及其他类别分类的非致命性SAEs。采用针对基线卒中严重程度（美国国立卫生研究院卒中量表，National Institutes of Health Stroke Scale, NIHSS）与年龄进行校正的二元logistic回归分析，评估其对死亡率的影响。 研究结果：共计2104名受试者被随机分配至VEM组（n=1054）与UC组（n=1050），受试者中位年龄为7……