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Clinical Trials/2024-518174-13-00
2024-518174-13-00
Not yet recruiting
Phase 3

A Prospective, randomized, single blind, multicenter Phase III study on organ preservation with Custodiol-N solution compared with Custodiol solution in liver transplantation

Dr. Franz Koehler Chemie GmbH7 sites in 1 country200 target enrollmentStarted: October 24, 2024Last updated:
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Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Dr. Franz Koehler Chemie GmbH
Enrollment
200
Locations
7
Primary Endpoint
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
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To evaluate the area under the curve (AUC) GPT (ALT) after transplantation during 7 days

Study Design

Allocation
Randomized
Primary Purpose
Custodiol-N / Custodiol
Masking
Single (Subject)

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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
  • 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
  • MEAF score (Model for early allograft dysfunction)
  • 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
  • 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
  • Number of episodes of cholestasis
  • Therapy for cholangitis
  • Episodes of biliary leakage and intrahepatic and/or extrahepatic biliary strictures
  • 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
  • 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

Investigators

Sponsor
Dr. Franz Koehler Chemie GmbH
Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Roman Petrov

Scientific

Dr. Franz Koehler Chemie GmbH

Study Sites (7)

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