Table 1 Flowchart
Schedule of activities | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 |
|---|---|---|---|---|---|
Screening day (day −1) | Day 0 (day of surgery) | Day 1 | Day 3 | Day 90 | |
Informed consent | X | ||||
Inclusion and exclusion criteria | X | ||||
Demographic data | X | ||||
Medical history (primary diagnosis) | X | ||||
Pregnancy test for women of childbearing potential | X | ||||
Mini Mental State Examination | X | ||||
Life Quality Assessment (ADL, IADL) | X | X | |||
Concomitant medications (diuretics) | X | X | X | X | X |
Cystatin C, GFR, serum creatinine | X | X | X | X | X |
ROTEM, Multiplate, PFA 100 | X | ||||
Randomization | X | ||||
NGAL, syndecan 1, hyaluronan | X | X | X | ||
Study drug | X | X | X | ||
Blood products | X | X | X | ||
IV fluid amount | X | X | X | ||
Blood losses and urine output | X | X | X | ||
Nursing Delirium Screening Scale | X | X | X | ||
AEs and SAEs | X | X | X | X | |
Pruritus assessment | X |