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Study on Liver Transplantation: Comparing Custodiol-N Solution with a Drug Combination for Organ Preservation in Patients Undergoing Liver Transplant Surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of two solutions used in liver transplantation. The solutions being compared are called Custodiol-N and Custodiol. These solutions are used to preserve organs, which means they help keep the liver healthy and functional until it can be transplanted into a patient. Custodiol-N contains a mix of substances like alanine, arginine, deferoxamine, and others, while Custodiol includes ingredients such as mannitol, histidine, and magnesium chloride hexahydrate.

The purpose of this study is to see how well these solutions work in preserving the liver during transplantation. Participants in the study will receive either Custodiol-N or Custodiol. The study will monitor the health of the liver after transplantation by measuring certain markers in the blood over a period of seven days. These markers include GPT (a liver enzyme), LDH (an enzyme that can indicate tissue damage), and other factors like bilirubin and INR (a measure of blood clotting).

Throughout the study, researchers will also look at other aspects of liver function and health, such as the occurrence of cholestasis (a condition where bile cannot flow from the liver to the duodenum), therapy for cholangitis (inflammation of the bile duct system), and any episodes of biliary leakage or strictures. The study aims to provide valuable information on which solution might be more effective in supporting liver health during and after transplantation.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. You will need to provide your signed informed consent, which confirms your understanding and agreement to participate in the study and the use of your data.

  2. Step 2

    Pre-transplantation phase

    You will be prepared for your liver transplantation. This includes routine medical assessments to ensure you are ready for the procedure.

  3. Step 3

    Transplantation procedure

    During the liver transplantation, the organ will be preserved using either the Custodiol-N solution or the Custodiol solution. These solutions are used to protect the organ during the surgery.

  4. Step 4

    Post-transplantation monitoring

    After the transplantation, your liver function will be closely monitored. This includes measuring the GPT (ALT) levels once per day for the first 7 days. This is a standard practice to assess liver function.

    Other parameters such as LDH (lactate dehydrogenase), bilirubin, and INR (international normalized ratio) will also be evaluated to check for any signs of liver dysfunction.

  5. Step 5

    Follow-up assessments

    At 3 months and 6 months after the transplantation, additional blood tests will be conducted to measure levels of serum bilirubin, GOT, GPT, LDH, total albumin, and PT (prothrombin time). These tests help in assessing the long-term function of the transplanted liver.

  6. Step 6

    End of study participation

    Your participation in the study will conclude after the final assessments at 6 months post-transplantation. The study is estimated to end by January 31, 2025.

Who can join the trial?

4 criteria

  • Recipients who are waiting for their first transplant.
  • Recipients who are 18 years or older.
  • Recipients who have signed a form agreeing to the use and protection of their data before the transplantation.
  • Recipients who are receiving a full organ transplantation.

Who cannot join the trial?

3 criteria

  • Patients who have not had a **liver transplant** cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

  • Custodiol-N solution

    is a special liquid used during liver transplantation to help protect the liver. It is designed to keep the liver healthy and functioning well while it is outside the body during the transplant surgery. This solution helps to preserve the liver by reducing damage that can occur when the liver is not receiving blood and oxygen.

  • Custodiol solution

    is another type of preservation liquid used in liver transplantation. Like Custodiol-N, it is used to protect the liver while it is outside the body during surgery. This solution helps to maintain the liver's health by minimizing injury during the transplant process, ensuring that the liver works properly once it is transplanted into the recipient's body.

What is already known about the treatment

Custodiol-N solution – Custodiol-N solution is administered as a liquid directly to the organ during liver transplantation to help preserve it. It is currently being studied in clinical trials to compare its effectiveness with the standard Custodiol solution. The main therapeutic use of Custodiol-N is to protect the liver during transplantation by reducing damage to the organ. At the molecular level, it works by stabilizing cell membranes and reducing metabolic activity, which helps to preserve the organ's function. It is classified as an organ preservation solution.

Investigated diseases

Liver Transplantation – Liver transplantation is a surgical procedure that involves replacing a diseased liver with a healthy liver from a donor. The process is typically considered for individuals with severe liver dysfunction or failure. After transplantation, the new liver takes over the functions of the original liver, such as detoxifying the blood, producing bile, and regulating metabolism. The progression after surgery involves monitoring for complications like rejection, infection, or bile duct issues. The liver's function is closely observed through various blood tests to ensure it is working properly. Over time, the body may adapt to the new liver, but ongoing medical care is essential to maintain health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518174-13-00Protocol codeCLN-LTX-III/08ESP/19Estimated enrolment200 patientsSponsorDr. Franz Koehler Chemie GmbH

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