Table 1.
Evaluation parameters at baseline and follow-up visits.
| Evaluation parameter | Baseline (enrollment) | Follow-up (telephone/video or on-site visits) | ||||||
|---|---|---|---|---|---|---|---|---|
| (Hospital admission) | Visit 1 (3 m) | Visit 2 (6 m) | Visit 3 (12 m) | Visit 4 (24 m) | Visit 5 (36 m) | Visit 6 (48 m) | Visit 7 (60 m) | |
| Informed consent | x | |||||||
| Inclusion criteria met | x | |||||||
| Demographics & medical history | x | |||||||
| Vital signs & neurological exam | x | |||||||
| Consciousness level (CRS-R) | x | x | x | x | x | x | x | x |
| Functional status (GOS-E, DRS) | x | x | x | x | x | x | x | x |
| Quality of life (EQ-5D) | x | x | x | x | x | x | x | x |
| Survival status | x | x | x | x | x | x | x | x |
| Rehospitalization & complications | x | x | x | x | x | x | x | x |
| Adverse events | x | x | x | x | x | x | x | x |
| Treatment records (SOC, medications, neuromodulation, including weekly contact time per discipline) | x | x | x | x | x | x | x | x |
| Neuroimaging (MRI/DTI/fMRI) | x | x | x | x | x | x | ||
| Biomarkers (NfL, S100B, GFAP) | x | x | x | x | x | x | ||
| Laboratory tests (CBC, electrolytes, etc.) | x | |||||||
| Primary outcomes (consciousness recovery, all-cause death, major CV events) | x | x | x | x | x | x | x | |
× Represents data collection timepoint. CRS-R, Coma Recovery Scale-Revised; GOS-E, Extended Glasgow Outcome Scale; DRS, Disability Rating Scale; EQ-5D, EuroQol 5-Dimensions; SOC, Standard of Care; NfL, Neurofilament Light Chain; GFAP, Glial Fibrillary Acidic Protein; CBC, Complete Blood Count.