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...