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Title: Fatal and non-fatal events within 14 days after early, intensive mobilization post stroke.
Austin Authors: Bernhardt, Julie;Borschmann, Karen ;Collier, Janice M;Thrift, Amanda G;Langhorne, Peter;Middleton, Sandy;Lindley, Richard I;Dewey, Helen M;Bath, Philip;Said, Catherine M ;Churilov, Leonid ;Ellery, Fiona;Bladin, Christopher;Reid, Christopher M;Frayne, Judith H;Srikanth, Velandai;Read, Stephen J;Donnan, Geoffrey A 
Affiliation: CCRE Therapeutics, Monash University, Melbourne, Australia
Westmead Clinical School, University of Sydney, Australia
Stroke, Nottingham University Hospitals NHS Trust, Nottingham, UK
Nursing Research Institute, St Vincent's Health Australia, Sydney and Australian Catholic University, Darlinghurst, Australia
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia
NHMRC Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery, Melbourne, Australia
Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK
Faculty of Medicine, The University of Queensland, Herston, Australia
Peninsula Health & Peninsula Clinical School, Monash University, Melbourne, Australia
Alfred Hospital, Melbourne, Australia
Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia
University of Melbourne, Melbourne Brain Centre, Parkville, Australia
Ambulance Victoria, Florey Institute of Neuroscience and Mental Health, Heidelberg, Australia
Eastern Health Clinical School, Monash University, Box Hill, Australia
Department of Medicine Austin Health, University of Melbourne, Heidelberg, Australia
School of Sciences, RMIT University, Melbourne, Australia
The Florey Institute of Neuroscience and Mental Health
School of Public Health, Curtin University, Perth
Physiotherapy, University of Melbourne, Parkville, Australia
Physiotherapy, Western Health, St Albans, Australia
Stroke Theme, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Australia
Eastern Health Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia
Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK
Issue Date: 3-Nov-2020
Date: 2020-11-03
Publication information: Neurology 2020; online first: 3 November
Abstract: This tertiary analysis from AVERT examined fatal and non-fatal Serious Adverse Events (SAEs) at 14 days. AVERT was a prospective, parallel group, assessor blinded, randomized international clinical trial comparing mobility training commenced <24 hours post stroke, termed very early mobilization (VEM) to usual care (UC). Primary outcome was assessed at 3 months. Included: Patients with ischaemic and haemorrhagic stroke within 24 hours of onset. 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 neurologic, immobility-related, and other. Mortality influences were assessed using binary logistic regression adjusted for baseline stroke severity (NIHSS) and age. 2,104 participants were randomized to VEM (n = 1,054) or UC (n = 1,050) with a median age of 72 years (IQR 63-80) and NIHSS 7 (IQR 4-12). By 14 days, 48 had died in VEM, 32 in UC, age and stroke severity adjusted Odds Ratio of 1.76 (95% CI 1.06-2.92, p = 0.029). Stroke progression was more common in VEM. Exploratory subgroup analyses showed higher odds of death in intracerebral haemorrhage and >80 years subgroups, but there was no significant treatment by subgroup interaction. No difference in non-fatal SAEs found. While the overall case fatality at 14 days post-stroke was only 3.8%, mortality adjusted for age and stroke severity was increased with high dose, intensive training compared to usual care. Stroke progression was more common in VEM. This study provides Class I evidence that very early mobilization increases mortality at 14 days post stroke. Australian New Zealand Clinical Trials Registry, ACTRN12606000185561.
DOI: 10.1212/WNL.0000000000011106
ORCID: 0000-0002-2787-8484
Journal: Neurology
PubMed URL: 33144512
Type: Journal Article
Appears in Collections:Journal articles

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