Table 3.
Patient registration | Screening | Visit 1 Transplant Day 0 |
Visit 2 Day 30 (+/−3 days) |
Visit 3 Day 90 (+3 days) |
Visit 4 Day 180 (+30 days) |
Extended follow-up 12 months+24 months (+/− 30 days) |
Informed consent | X | |||||
Eligibility assessment | X | X | ||||
Patient history | X | X | ||||
Standard routine blood tests* | X | X | X | X | X | X |
MELD (automatically calculated) | X | |||||
UKELD (automatically calculated) | X | |||||
Trial-specific additional patient samples blood and urine | X | X | X | X | ||
PBMC collection | X | X | X | X | ||
Liver biopsy 4 (see table 2) | X | |||||
Quality of life questionnaire (EQ-5D-5L) | X | X | X | |||
Patient resource log at visit one discharge | X | |||||
Adverse/Clinical events | X | X | X | X | X | X |
Concomitant medications | X | X | X | X | X | X |
MRCP | X |
*Standard routine blood tests—FBC, urea, electrolytes, liver function tests, AST, GGT, eGFR, INR.
AST, aspartate transaminase; eGFR, estimated glomerular filtration rate; EQ-5D-5L, EuroQoL 5 Dimensions 5 Levels; FBC, full blood count; GGT, gamma glutamyl transferase; INR, international normalised ratio; MELD, model for end-stage liver disease; MRCP, magnetic resonance cholangiopancreatography; PBMC, peripheral blood mononuclear cell; UKELD, UK end-stage liver disease.