Table 1

Time and events schedule—PEARL trial

ProcedureScreeningDay 7
(baseline)		Day 3Day 0
TIPS		Day 10W4W12W26W52
Window (days)max - 21±4  ±7±7±7±7±7
Eligibility assessments          
Informed consentX        
Inclusion/exclusion criteriaX        
Medical history +concomitant medicationX        
Study medication    Graphic   
Assessments          
Physical examination* XX  XXXXX
Liver frailty index X    X X
Assessment of hepatic encephalopathy by West Haven criteriaXX  XXXXX
Assessment of hepatic encephalopathy by PHES and S-ANT1 X   XX X
Assessment of quality of life†  X    X X
Economic evaluation questionnaires‡  X    X X
Assessment of adverse events   XXXXXX
Assessment of compliance and concomitant medication   XXXXXX
Laboratory tests§XX  XXX X
Storage of peripheral blood and/or portal (*) vein blood X  X*  X X
Storage of stool sample X X  X X
Storage of saliva samples X X  X X
Radiological assessment and flow measurementX   X X X

  • NB: Visit day 7 might be the same as the day of start study medication.

  • *Height and weight, vital signs, including pulse rate, blood pressure, respiration rate and temperature, signs of ascites or oedema.

  • †EQ-5D-5L questionnaire and LDSI 2.0 questionnaire.

  • ‡Adapted version of the Productivity Cost Questionnaire and Medical Consumption Questionnaire.

  • §Clinical chemistry: sodium, potassium, serum creatinine, glucose, alanine aminotransferase, aspartate aminotransferase, total and direct bilirubin, alkaline phosphatase, gamma-GT, C reactive protein, albumin, ammonia. Coagulation: international normalised ratio, PT. haematology: haematocrit, haemoglobin.

  • PHES, Psychometric Hepatic Encephalopathy Score; S-ANT1, simplified one min animal naming test.