Visit | Screening | Treatment | Assessment | ICU follow-up | 30-day and 1-year follow-upb | |
---|---|---|---|---|---|---|
Time (hours, days, weeks) | − 1 h | 0 | 30–60 min | 1 day | 2 days | 12 months |
Patient information and informed consent | xa | xa | xa | xa | xa | |
Demographics | x | |||||
Medical history | x | |||||
In-/exclusion criteria | x | |||||
Vital signs | x | x | x | x | ||
Platelet function analysis | x | x | ||||
Laboratory tests | x | x | x | x | ||
Pregnancy test | x | |||||
Randomisation | x | |||||
Information related to bleeding | x | x | x | x | ||
Study medication | x | |||||
Primary outcome variable | x | x | x | |||
Secondary outcome variables | x | x | x | x | ||
Adverse events | x | x | x | |||
Mortality ICU Hospital 30 days 1 year | x | x | x |