STAGES | V1 Screening | V2 Inclusion | V3 | V4 | V5 –V11 | V12 | V13-V16 | ||
---|---|---|---|---|---|---|---|---|---|
Time point Actions | At inscription for LT or at pre LT visit | D0 At hospitalization for LT | D0 HOPE group only | D0 + 6 h (± 2 h) after LT | D0 + 12 h (± 2 h) after LT | Day 1 to day 7 (± 1 day) | End of hospital stay | M3; M6: M9 and M12 (± 30 days) | |
Inclusion / non-inclusion criteria | X | X | |||||||
Informed consent | X | ||||||||
Medical history and patient characteristics1 | X | ||||||||
MELD score | X At inscription | X | |||||||
Randomization2 | X | ||||||||
Clinical examination3 | X | X | X | ||||||
Biological analyses4 | X (before LT) | X | X | X | X | X | |||
CHILD–PUGH score | X (before LT) | ||||||||
Donor characteristics5 | X | ||||||||
HOPE perfusion parameters6 | X | ||||||||
Bacteriological and fungal analyses7 | X | X | |||||||
Intra-operative data8 | X | ||||||||
Liver Biopsy9 | X both groups | X | |||||||
Machine perfusate sample10 | X | ||||||||
ICU and hospital stay | X | ||||||||
Morbidity (Clavien-Dindo Score, CCI) | X | X At M3 only | |||||||
Concomitant Medication | X | X | X | X | X | X | |||
Adverse events | X | X | X | X | X | X | |||
Abdominal contrast enhanced MRI/MRCP | X At M12 only |