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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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- 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. Text added to the consultee information sheet relating to independent physician consent to provide better clarity. 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. The sub-study will only take place at centres where all the research exposures will be standard care. No change to the ionising radiation exposure is required.
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- Substantial protocol change: Updated to indicate that eligibility can be confirmed and consent obtained by members of the research team (which may include research nurses, research practitioners, research associates and research coordinators) who have local approval to do so and are authorised onto the delegation log with the consent taking role.
- Non-substantial protocol change: Minor formatting updates. Removed reference to COVID-19 status being checked post randomisation. Clarified that the treatment period during which all SAEs need to be reported is within the first 20 days after randomisation (fatal SAEs and safety outcome events continue to be reported from randomisation until day 90). Clarified that non-serious AEs do not need to be reported to the coordinating centre.
- Information sheets: wording amended to indicate that there will be a gap of >4 hours between intervention doses (correction to align with existing approved protocol), and updated to provide space for local PALS and research team contact details to be documented.
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- The amendment involves an update to the device model and manufacturer (AT4 Electronic Tourniquet System, Medical Device Management Ltd.) and relevant changes to the protocol and patient-facing documentation.
- Full details of the updates are listed in the amendment tool.
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- The amendment involves an update to the device model and manufacturer (AT4 Electronic Tourniquet System, Medical Device Management Ltd.) and relevant changes to the protocol and patient-facing documentation.
- Full details of the updates are listed in the amendment tool.
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