Screening | Study period | Follow-up period | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
T0 | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Discharge | Day 7 | Day 14 | Day 28 | ||
Enrollment | Eligibility screen | x | |||||||||
Informed consent | x | ||||||||||
Randomization and allocation | x | ||||||||||
Intervention | Standardized workup | x | x | x | |||||||
Standardized therapy | x | x | x | x | x | x | x | x | |||
Drug or placebo (q8h) | x, x, x | ||||||||||
Assessment | Complete blood count | x | x | x | x | x | |||||
Serum chemistry (LDH, HI, Hb, bilirubin) | x | x | x | x | x | ||||||
C5b-9 complex | x | x | x | x | x | ||||||
Residual plasma complement | x | x | x | x | x | ||||||
Serum haptoglobin concentration | x | x | x | x | x | ||||||
Erythrocyte bound C3b | x | x | x | x | x | ||||||
Duration of hospitalization | x | ||||||||||
Red cell transfusion requirements | x | ||||||||||
Rescue therapy requirements | x | ||||||||||
Survival (Alive, died, euthanized) | x | x | x | x | |||||||
Follow-up | Telephone follow-up | x | x | x |