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- Substantial protocol changes: Inclusion criteria for the main trial updated based on previous trial results: (i) NIHSS change from 5-25 to 4 to 25 and (ii) Inclusion timeframe changed from ≤24 hours post onset to ≤48 hours post onset. Exclusion criteria updated as follows: (i) Added ‘pre-existing condition of the upper limbs which in the opinion of the investigator will be exacerbated by remote ischaemic conditioning’. (ii) Clarified that expected repatriation <72 hours is an exclusion criterion. Update to indicate that all SAEs to be reported for 28 days after randomisation (change from 20 days). Sub-study details updated: Baseline CTP will be performed as part of standard care. Day 2-14 MRI replaced by a day 2 (standard care) CT. Mechanistic outcome details and sites updated.
- Non-substantial protocol changes: Minor formatting updates. Minor updates to ongoing and recent stroke RIC studies. Intervention to be delivered for up to 14 days (28 doses). Minimum of 2 doses (change from 4 doses) required prior to omitting weekend doses and pragmatic approach to be taken regarding gap between daily doses - no minimum requirement, but recommend a couple of hours. Minimisation factors and planned sub-group analysis updated. TMG meeting frequency corrected to monthly. Progress review details updated. Device fault reporting process updated. Neuro-imaging data collection requirements clarified. Sub-study mechanistic outcome details and sites updated. Outcome event definition for neurological deterioration definition updated to include sustained drop in GCS by 2 or more points.
- Information sheets: wording amended to reflect changes made to the protocol. Minor formatting updates.Consent forms: Text relating to witnessing/taking verbal consent updated to provide better clarity of requirements. Reference to the sub-study involving an additional CT Perfusion scan removed as this scan will be done as standard of care. Minor formatting updates.
- Sub-study procedure updated as follows: Baseline CTP will be performed as part of standard of care. Day 2-14 MRI will be replaced by a day 2 (standard of care) CT.
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