Table 2 Schedule of study related activities and data collection. The following study related activities are planned for each subject. Blood samples already taken in the routine process at the planned time do not have to be taken twice.
Clinical period | Follow-up period | ||||||
|---|---|---|---|---|---|---|---|
Study related activity | pre-OP | OP | ICU-entry | POD 1 | POD 2–7 | POD 8 | |
Informed consent | x | ||||||
Medical history | x | ||||||
Physical examination | x | ||||||
Donor and graft history | x | ||||||
Randomisation | x | ||||||
Treatment | x | x | x | ||||
Safety parameters (measured after 5 a.m. before additional treatment, unless otherwise stipulated) | |||||||
12-lead ECG | x | x | |||||
Vital signs | x | x | x | x | x | ||
Blood chemistry | x | x | x | x | x | ||
Haematological parameters | x | x | x | x | x | ||
Coagulation parameters | x | x | x | x | x | ||
CyA (trough concentration) | x | x | x | ||||
Pregnancy testing | x | ||||||
Efficacy Parameters (measured after 5 a.m. before additional treatment, unless otherwise stipulated) | |||||||
Biopsy | x | (immediately after rearterialisation) | |||||
Blood flow in portal vein and common hepatic artery | x | (1 hour after reperfusion) | |||||
AST, ALT | x | x# | x# | x | x | ||
Biltotal, Bildir, Quick, AT III | x | x | x | x | x | ||
Gly* | x | x (POD3) | |||||
KreaS, HS | x | x | x | x | x | ||
24-hours-urine (VolU, KreaU) | start | x | x | ||||
Indicators for early onset of graft failure | x | x | x | ||||
Occurrence of late onset of graft failure | X | ||||||