Protocol
Protocol Version
Changes since previous version
Valid
✅ Expanded Steering Committee
✅ Expanded Advisory/Support Group
✅ Clarified version tracking section
✅ Randomization procedure clarified to be performed using sealed envelopes instead of a digital randomization system
✅ Specified that neuroprognostication is not required for participants who are awake at 72 hours
✅ Minor editorial and formatting revisions throughout the document
Valid 04.15.2026 – current
Superceded versions
✅ Co-PI formatted.
✅ Minor administrative and formatting updates to the cover page and document layout (version formatting, spacing and typography).
✅ No changes to study design, eligibility criteria, interventions, endpoints, procedures, statistical methods or safety assessments.
Valid 11.14.2024 – 04.15.2026
✅ ClinicalTrials.gov registration added
✅ Expanded Steering Committee
✅ Expanded Advisory/Support group
✅ Upper age limit changed from 80 years to 79 years
✅ Planned sample size increased from 924 to 1022 participants to account for one interim analysis. Sample size including estimated loss to follow-up.
✅ Statistical section clarified and expanded, including:
⟢ description of a pilot/interim phase
⟢ clearer description of safety monitoring
✅ Minor editorial and structural revisions throughout the documentÂ
Valid 10.23.2023-11.14.2024
✅  First published version
Valid and approved 12.15.2022 until 10.23.2023