ALANINE, ARGININE, DEFEROXAMINE, HISTIDINE, ASPARTIC ACID, GLYCINE, TRYPTOPHAN, SUCROSE, CALCIUM, MAGNESIUM, POTASSIUM, SODIUM, N-HYDROXY-3,4-DIMETHOXY-N-METHYL-BENZAMIDE, N-ACETYLHISTIDINE, CHLORIDE ION, OXOGLURIC ACID for Liver transplantation

Inclusion criteria

• {"criterion_text":"- Recipients awaiting their first transplant"}
• {"criterion_text":"- Recipients ≥18 years"}
• {"criterion_text":"- Recipient's signed informed consent of data use and protection before the transplantation"}
• {"criterion_text":"- Full organ transplantation"}

Exclusion criteria

• {"criterion_text":"- Pregnant or lactating patients"}
• {"criterion_text":"- Recipients participating in any interventional study (e.g. another study involving compound/interventions aimed at the reduction of preservation and/or ischemia/reperfusion injury)"}
• {"criterion_text":"- All combined transplantations other than pancreas and kidney"}
• {"criterion_text":"- High urgency patients"}
• {"criterion_text":"- Patients in need of a retransplant"}

Primary endpoints

• {"endpoint_text":"- Area under the curve (AUC) GPT (ALT) after transplantation during 7 days: with each liver transplant patient enrolled in the study, GPT will be measured once per day during the first 7 days, according to the standard practice of the center laboratory. Area under the curve will be analysed for this variable comparing Custodiol and Custodiol-N groups","definition_or_measurement_approach":"GPT will be measured once per day during the first 7 days according to standard practice of the center laboratory; AUC over 7 days will be calculated and compared between Custodiol and Custodiol-N groups."}

Secondary endpoints

• {"endpoint_text":"- Absolute peak LDH within 7 days after transplantation: the highest peak of lactate-dehydrogenase within 7 days after transplantation according to the practice of the site laboratory","definition_or_measurement_approach":"Highest LDH value within 7 days post-transplant as measured by site laboratory practice."}
• {"endpoint_text":"- Olthoff criteria: bilirubin, international normalized ratio of prothrombin (INR). The Olthoff criteria will be applied to evaluate initial poor function when one or more of the following parameters would be present: Bilirubin ≥ 10 mg/dl on Day 7 after the surgery; INR ≥ 1.6 on Day 7 after the surgery; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2000 IU/L within the first 7 days after the surgery","definition_or_measurement_approach":"Apply Olthoff criteria: presence of any listed laboratory parameter within first 7 days post-surgery indicates initial poor function (bilirubin ≥10 mg/dl on Day 7; INR ≥1.6 on Day 7; ALT or AST >2000 IU/L within first 7 days)."}
• {"endpoint_text":"- MEAF score (Model for early allograft dysfunction)","definition_or_measurement_approach":"MEAF score calculated per standard definition for early allograft dysfunction."}
• {"endpoint_text":"- Evaluation of the moment (day) of peak GPT and peak LDH: the highest daily peak GPT and peak LDH will be evaluated for comparisons between groups","definition_or_measurement_approach":"Day of highest daily GPT and highest daily LDH will be recorded and compared between groups."}
• {"endpoint_text":"- Evaluation of the serum bilirubin, GOT, GPT, LDH, total albumin and PT at 3 months and 6 months: these parameters will be measured at 3 months and 6 months after liver transplantation according to the references values of the site laboratory","definition_or_measurement_approach":"Laboratory measurements of listed parameters at 3 and 6 months post-transplant using site laboratory reference ranges."}
• {"endpoint_text":"- Number of episodes of cholestasis","definition_or_measurement_approach":"Count of cholestasis episodes as recorded during follow-up."}
• {"endpoint_text":"- Therapy for cholangitis","definition_or_measurement_approach":"Recording and comparison of treatments administered for cholangitis."}
• {"endpoint_text":"- Episodes of biliary leakage and intrahepatic and/or extrahepatic biliary strictures","definition_or_measurement_approach":"Recording and comparison of biliary leakage episodes and biliary strictures (intrahepatic and/or extrahepatic)."}
• {"endpoint_text":"- Comparison in Extended Criteria Donors: the influence of Custodiol-N in liver transplants with ECD and DCD donors will be compared. ECD donors are defined as high risk donors with a donor risk index (DRI) higher than 1.7","definition_or_measurement_approach":"Comparative analysis of outcomes in liver transplants from ECD (DRI >1.7) and DCD donors between solutions."}
• {"endpoint_text":"- Comparison in DCD donors: DCD donors are defined as donation after circulatory death donors and will be compared in liver transplants with Custodiol and Custodiol-N","definition_or_measurement_approach":"Comparative analysis of outcomes in transplants from DCD donors between Custodiol and Custodiol-N."}

Spain

Earliest CTIS Part Ii Submission Date

17-09-2024

Latest Decision Or Authorization Date

24-10-2024

Processing Time Days

37

Number Of Sites

7

Number Of Participants

200

Primary sponsor

Full Name

Dr. Franz Koehler Chemie GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Third parties

• {"country":"Spain","full_name":"Farmavenix S.A.","duties_or_roles":["14"],"organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Fundacion Para La Investigacion Biomedica De Cordoba","duties_or_roles":["1","10","12","5"],"organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Spain","full_name":"Kapadi Spain S.L.","duties_or_roles":["8"],"organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"KKS-Netzwerk e. V. Netzwerk Der Koordinierungszentren Fuer Klinische Studien","duties_or_roles":["8"],"organisation_type":"Laboratory/Research/Testing facility"}