Tabular listing of schedule of events and assessments and procedures of the study
Study periods | Before surgery | Surgery | Discharge from hospital | 90-day follow-up | 12-month follow-up |
Visit | 1 | 2 | 3 | 4 | 5 |
Time (days) | 0 (-7–0) | 0 | 5 (3–14) | 90 (±10) | 365 (±30) |
Patient information and informed consent | x | (x) | (x) | ||
Demographics | x | ||||
Medical history | x | ||||
Inclusion /exclusion criteria | x | ||||
Physical examination | x | x | x | ||
Laboratory examinations | |||||
Quick/INR/PTT Thrombocyte count | x x | ||||
Randomisation | x | ||||
Other examinations (CT scan) Haematoma volume | x x | x x | x x | ||
Administer medical device (burr hole covers and screws) | x | ||||
Primary outcome | |||||
Patient satisfaction (ANA) | x | x | |||
Secondary outcomes | |||||
Impairment in ADLs | x | x | |||
Skin depression | x | x | |||
HrQoL (EQ-5D) | x | x | x | ||
Disability (mRS) | x | x | x | ||
Neurological status (NIHSS) | x | x | x | ||
Complications (CDG) | x | x | x | ||
Adverse events | x | x | x | x B | x |
ADLs, activities of daily living; ANA, Aesthetic Numeric Analogue; CDG, Clavien-Dindo Grading; EQ-5D, euroQol five dimension; HrQol, health-related quality of life; INR, international normalised ratio; mRS, modified Rankin Scale; NIHSS, National Institute of Health Stroke Scale; PTT, partial thromboplastin time.