Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial

Table 2 Visit and assessment schedule

Activities	Screening	Day 1	Days 2–6	Day 7	Week 2 ± 1D	Week 3 ± 1D	Week 4 ± 1D	Week 8 ± 3D (treatment end)	Week 12 ± 3D⁴	Week 24 ± 7D⁴
Informed consent	√
History collection
Inclusion/Exclusion	√
Concomitant medication¹		√	√	√	√	√	√	√	√	√
Physical examination	√			√	√	√	√	√	√	√
Surgery conversion		√	√	√	√	√	√	√	√	√
Efficiency observation
Neurological symptoms²	√	√	√	√	√	√	√	√	√	√
Hematoma volume by CT²	√						√	√	√	√
MGS-GCS/ADL-BI²	√			√			√	√	√	√
GOS							√	√	√	√
Safety assessment
Vital signs	√	√	√	√	√	√	√	√	√	√
Blood routine/Coagulation	√						√	√	√	√
Liver and renal function/Electrolyte/Lipids	√						√	√	√	√
Urinalysis	√							√		√
Electrocardiography	√							√		√
Pregnancy test	√
Adverse events		√	√	√	√	√	√	√	√	√
Others
Drug dispensing	√			√	√	√	√
Drug recovery³				√	√	√	√	√

ADL-BI Activities of Daily Life – the Barthel Index scale, CT computerized tomography, D day, GOS Glasgow Outcome Score, MGS-GCS Markwalder’s Grading Scale and Glasgow Coma Scale
¹Records of combination therapy are required until the end of the trial
²Surgical therapy is considered in the case of deterioration in neurological symptoms and/or signs, MGS-GCS grading and increase of hematoma immediately imaging review then
³The remaining drugs need to be recovered
⁴At weeks 12 and 24, CT should be performed; other laboratory examinations will be selected when needed

ISSN: 1745-6215