Table 1

Tabular listing of schedule of events and assessments and procedures of the study

Study periodsBefore surgerySurgeryDischarge from hospital90-day follow-up12-month follow-up
Visit12345
Time (days)0 (-7–0)05 (3–14)90 (±10)365 (±30)
Patient information and informed consentx(x)(x)
Demographicsx
Medical historyx
Inclusion /exclusion criteriax
Physical examinationxxx
Laboratory examinations
Quick/INR/PTT
Thrombocyte count
x
x
Randomisationx
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)xx
Secondary outcomes
Impairment in ADLsxx
Skin depressionxx
HrQoL (EQ-5D)xxx
Disability (mRS)xxx
Neurological status (NIHSS)xxx
Complications (CDG)xxx
Adverse eventsxxxx Bx
  • 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.