OPTIMISTmain
Research type
Research Study
Full title
An investigator-initiated and conducted, international, multicentre, stepped-wedge cluster, randomised controlled trial comparing the effects of different intensities of nursing care monitoring for patients with acute ischaemic stroke without critical care needs after thrombolysis treatment
IRAS ID
313025
Contact name
Thompson Robinson
Contact email
Sponsor organisation
The George Institute for Global Health
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
Ischaemic (clot related) stroke is the most common stroke subtype and is associated with mortality (15% at 30 days) and long-term disability. Up to 20% of ischaemic stroke patients are eligible for clot-busting therapy, which significantly improves outcome but with a small, but significant, risk of bleeding, especially in the brain. Guidelines recommend that patients are monitored frequently for up to 24 hours following clot-busting therapy, though this recommendation is historical (based on the original trial in the early 1990s) and does not take account of the greater experience with this treatment, the much lower rates of bleeding and the fact that bleeding tends to happen during the clot-busting treatment itself. Importantly, this results in a large proportion of trained nurse time being taken up with routine observations, when this might be better utilised with other aspects of acute stroke care, e.g. feeding and fluids, early rehabilitation, and information provision and support to patients and families. Therefore, the OPTIMISTmain trial will compare a guideline-recommended versus less-intense monitoring schedule for 24 hours following clot-busting therapy in nearly 9,000 patients at over 100 hospitals worldwide. The key difference in the monitoring schedule is over the 2- to 24-hour time period; there will be no difference in the frequency of monitoring over the first 2 hours, when most bleeding complications tend to occur. Hospitals will be randomised to either a guideline-recommended or less-intense monitoring schedule, so that all patients admitted will receive the same monitoring. However, individual participants will consent to routine information from their medical record being entered into the trial database, including whether they had bleeding complications from clot-busting treatment, and to a telephone contact at 3 months to determine their recovery from stroke.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
22/YH/0092
Date of REC Opinion
9 Jun 2022
REC opinion
Further Information Favourable Opinion