Table 2.
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 |
#; AST and ALT will be measured every 4 to 6 hours during the first 24 hours after ICU entry.
*; Samples for glycine plasma level has to be collected immediately after first study drug application during surgery and on POD 3 (after study drug application).