Time point | |||||||
---|---|---|---|---|---|---|---|
Day | Day 1 | Day 1 | Day 1 | Day 1 | Day 2 | Day 4 | Day 30 (follow-up) |
Hours | 0 hrs baseline (before infusion) | 15 min | 2 hrs | 6 hrs | 24 hrs | 72 hrs | |
Informed consent | X | ||||||
Demographics/medical history | X | X | X | ||||
Weight | X | ||||||
Clinical parametersa | X | X | X | X | X | X | |
Co-medicationb, incl. fluids/blood | X | X | X | X | X | X | |
Haematology/biochemistry | X | X | X | X | X | X | |
Thrombelastography | X | X | X | X | X | X | |
Drug/placebo administration | X | ||||||
Serious adverse events | X | ||||||
Mortality | X | X |