Table 2 Five elements of outcomes
Domain | Specific measurement | Specific metric | Method of aggregation | Time point | |
|---|---|---|---|---|---|
Primary outcome | The Modified Rankin Scale (mRS) score | The Modified Rankin Scale (mRS) score | Change from baseline to 14, 28, 60, 90, and 180 days | Proportional-odds logistic-regression model | Baseline, 14, 28, 60, 90, and 180 days |
Secondary outcome | National Institutes of Health Stroke Scale (NIHSS) score | National Institutes of Health Stroke Scale (NIHSS) score | Change from screening period to 14, 28, 60, and 90 days | Repeated-measures analysis model | Screening period, 14, 28, 60, and 90 days |
Activity of Daily Living (ADL) Scale score (Barthel index) | Activity of Daily Living (ADL) Scale score (Barthel index) | Change from baseline to 90 and 180 days | Repeated-measures analysis model | Baseline, 90 and 180 days | |
Prothrombin time (PT) | Prothrombin time (PT) | Change from baseline to 14, 28, 60, and 90 days | Repeated-measures analysis model | Baseline, 14, 28, 60, and 90 days | |
Activated partial thromboplastin time (APTT) | Activated partial thromboplastin time (APTT) | Change from baseline to 14, 28, 60, and 90 days | Repeated-measures analysis model | Baseline, 14, 28, 60, and 90 days | |
Serum fibrinogen (FIB) concentration | Serum fibrinogen (FIB) concentration | Change from baseline to 14, 28, 60, and 90 days | Repeated-measures analysis model | Baseline, 14, 28, 60, and 90 days | |
Serum hypersensitive C-reactive protein (hs-CRP) | Serum hypersensitive C-reactive protein (hs-CRP) | Change from baseline to 90 days | Repeated-measures analysis model | Baseline, 90 days |