Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)

Launched by DR. F. KÖHLER CHEMIE GMBH · Aug 8, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new solution called Custodiol-N to see if it is as good as the standard solution, Custodiol, for preserving organs like kidneys, livers, and combined kidney-pancreas transplants. The main goal is to determine if Custodiol-N can help keep the organs healthy and functioning well after transplantation. The trial will involve around 362 patients who are waiting for these types of transplants, and they must be at least 18 years old to participate.

If you or someone you know is considering participating, you should know that the study will last about 30 months in total, with each participant involved for around three months. Participants will receive one of the two solutions during their transplant surgery, and doctors will monitor their recovery for 90 days afterward. It's important to remember that certain patients may not be eligible, such as those who are pregnant or participating in other studies. This trial aims to improve organ transplantation outcomes, potentially benefiting many patients in need of transplants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All organs (kidney, combined kidney - pancreas and liver) Donor criteria
• For All patients undergoing deceased donation:
• • - deceased adult (≥18 years) donors fulfilling the criteria for organ donation
• For All patients undergoing living kidney donation:
• • - adult (≥18 years) living kidney donors fulfilling the criteria for organ donation
• • Patient (recipient) criteria
• • recipients awaiting their transplant
• • recipients ≥18 years
• • recipients' signed informed consent before the transplantation Kidney / combined kidney - pancreas recipients
• • n/a Liver recipient
• • full organ transplantation
• Exclusion Criteria:
• • All organs (kidney, combined kidney - pancreas and liver) Donor criteria (not applicable for living kidney donors)
• • - donors whose organs are all allocated out of retrieving study center
• • general refusal of organ donation
• • donation after cardiac death (DCD) Patient (recipient) 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 allocations other than pancreas and kidney
• • Kidney / combined kidney -pancreas recipient
• • double kidney transplantation
• • pancreas retransplantation
• • machine perfusion According to the KDIGO-Guidelines (2009) all patients with PRA \>0% are only included in the living donation setting.
• • Liver recipient
• • retransplantation
• • machine perfusion