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 |
ADL activities of daily living, AE adverse event, IADL instrumental activities of daily living, IV intravenous, NGAL neutrophil gelatinase-associated lipocalin, PFA 100 Platelet Function Analyzer 100, ROTEM rotational thrombelastometry, SAE serious adverse event2