Abstract T P117: Progress Update From a Very Early Rehabilition Trial
Introduction: Very early rehabilitation may be an important component of effective stroke unit care, but this requires testing. AVERT is an international clinical trial which can enroll eligible patients treated with rtPA if the physician allows. Patients randomized to intervention, commence training within 24hrs of stroke onset.
Hypothesis: AVERT tests whether very early and frequent out of bed activity post stroke reduces 90 day death and disability. Due to the 24 hour time window, we hypothesized that around 20% of patients in the trial would be treated with rtPA.
Methods: Inclusion criteria: adults over 18 yrs admitted within 24 hrs of stroke, whose physiological parameters fall within set limits. Exclusions: patients with severe premorbid disability, severe comorbidities or requiring palliative care. The intervention is delivered by a nurse/physiotherapy team and starts within 24 hours, for a maximum of 14 days. Control group patients receive standard care. A blinded assessor evaluates 3 and 12 month outcomes. Primary outcome: 3 month modified Rankin Scale. Secondary outcomes include complication rates, quality of life, time to walking (days) and cost effectiveness. Sample size is 2104 patients (n=1052 per group) with recruitment from 5 countries (Australia, New Zealand, Malaysia, Singapore, UK). Patients are followed for 12 months with primary endpoint (mRS) at 90 days.
Results: Current recruitment sits at 2017 patients and is expected to close in early October 2014. Recruited patients: mean(SD) age: 70.6(12.9) years; male: 61.0%; first stroke: 81.5%; infarct 87.8%; mean(SD) NIHSS: 8.7(6.3); rtPA: 24.0%. Data completion rates are excellent: primary and secondary outcome over 90%, cognitive function and mood over 80%. rtPA patients have been recruited from Australia (250 patients), UK (189), New Zealand (30), Singapore and Malaysia (6 each).
Conclusions: The trial data quality is high. The Data Monitoring Committee has met 14 times and no safety issues have been identified. By the conclusion of the trial we expect to have recruited 500 patients treated with rtPA.
Author Disclosures: G. Donnan: None. R. Lindley: None. A. Thrift: None. H. Dewey: None. P. Langhorne: None. J. Bernhardt: None.
- © 2015 by American Heart Association, Inc.