Table 1.
Schedule of assessments for THAWS trial
| Baseline |
Administration of treatment |
Observational period |
|||
|---|---|---|---|---|---|
| Timing | Enrollment | 0 h | 24 h* ± 3 h | Day 7 or discharge ± 1 day† | Day 90 ± 14 days |
| Consent | ○ | ||||
| Demographics/Baseline information/Medical history/Prior medication | ○ | ||||
| Screening/Eligibility | ○ | ||||
| Randomization | ○ | ||||
| Physical examination | |||||
| NIHSS | ○ | ○ | ○ | ||
| mRS | Premorbid | ○ | ○ | ||
| Height/Weight | ○ | ||||
| Blood pressure/Pulse rate | ○ | ○ | ○ | ||
| Body temperature | ○ | ||||
| Laboratory tests/Imaging | |||||
| Blood test | ○ | ○ | |||
| Urine test | ○ | ||||
| Electrocardiogrphy | ○ | ||||
| MRI | ○ | ○* | ○† | ||
| Adverse events | ○ | ○ | ○ | ○ | |
| Alteplase administration | ○ | ||||
*
Follow-up MRI at 24 h is allowed to be obtained between 22 and 36 h after the treatment administration.
†
Follow-up MRI at day 7 is allowed to be obtained between 7 and 14 days after the treatment administration or at discharge (whichever is first).
MRI, magnetic resonance imaging; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.