Per-protocol population
bleeding
BLEEDING, HEMODYNAMIC INSTABILITY, COMPLICATIONS, SECONDARY
The per-protocol-population will include all patients who received intervention or sham intervention (placebo) and surgery without major protocol deviations. Significant protocol deviations or complications (hemodynamic instability, prolonged intubation, reintubation, bleeding, reoperation) and subsequent failure to obtain primary and secondary outcome data will be documented before the database lock.