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. 2022 Apr 11;23:285. doi: 10.1186/s13063-022-06200-4

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