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Table 1 Schedule of enrolment, interventions, and assessments in the HOPExt trial

From: End-ischemic hypothermic oxygenated perfusion for extended criteria donors in liver transplantation: a multicenter, randomized controlled trial—HOPExt

Stages

V1 screening

V2 inclusion

V3

V4

V5–V11

V12

V13–V16

Time point

At inscription for LT or at pre-LT visit

D0 At hospitalization for LT

D0 HOPE group only

D0 + 6h (+/-2h) after LT

D0 + 12h (+/-2h) after LT

Day 1 to day 7 (+/-1day)

End of hospital stay

M3; M6: M9 and M12 (+/-30 days)

Actions

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

  1. 1Patient characteristics: age, gender, height, weight, BMI, blood group, cause of cirrhosis, indication for transplantation, medical history (diabetes mellitus, arterial hypertension, transjugular intrahepatic portosystemic shunt), pretransplant status of residence (home, hospital ward or intensive care unit (ICU))
  2. 2Randomization will be performed after the harvesting team has macroscopically assessed the graft and confirmed that the graft will be harvested. After checking the inclusion and non-inclusion criteria, an online randomization tool will be used. Randomization will be stratified by center and MELD score at the time of transplantation with a cut-off of 30
  3. 3Clinical examination: vital signs (temperature, blood pressure, heart rate), body weight, height, BMI
  4. 4Biological analyses: AST, ALT, GGT, alkaline phosphatase, bilirubin, factor V, INR, platelets, creatinine, GFR, lactates. At V2 only, a pregnancy test (beta HCG) will be done for women of childbearing age
  5. 5Donor characteristics: age, gender, height, weight, BMI, blood group, length of stay in intensive care unit, cause of death, occurrence of cardiac arrest, biological test (AST, ALT, natremia)
  6. 6Parameters measured during HOPE perfusion (only in HOPE group): perfusion pressure, flow, temperature, duration of machine perfusion, perfusate oxygenation (partial pressure O2), and CO2 content (partial pressure CO2) at the beginning and at the end of machine perfusion; perfusate AST and ALT, LDH, hyaluronic acid, lactate levels at 30 min, and at the end of machine perfusion
  7. 7Bacteriological and fungal samplings will be taken on static storage solution (IGL-1) at the end of the back-table in both groups and of the perfusion solution at the end of machine perfusion for HOPE group
  8. 8Intra-operative data: surgical technique of transplantation (piggy-back vs. vena cava resection), length of procedure, transfusion needs (fresh frozen plasma, red blood cell, thrombocyte concentrate), occurrence of post-reperfusion syndrome (decrease of 50% of the median arterial pressure during the 5 min after the revascularization), cold ischemia time, circulatory support at the end of transplantation (noradrenaline (mg/h))
  9. 9A biopsy will be taken on the back-table before machine perfusion in both study groups, immediately after liver machine perfusion in the HOPE group, and after reperfusion of the liver in both groups
  10. 103 ml sample will be taken from machine perfusion solution during HOPE perfusion (only in HOPE group), at 30 min and at the end of machine perfusion
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Trials

ISSN: 1745-6215