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Search / Trial NCT05166460

Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation

Launched by THOMAS SKINNER · Dec 6, 2021

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Kidney Transplant Warm Ischemia Time Delayed Graft Function Vascular Anastomosis Renal Hypothermia

ClinConnect Summary

This clinical trial is investigating a new cooling device designed to protect kidneys during transplantation surgery. When a kidney is transplanted, it can be exposed to warm temperatures, which may cause damage. The cooling device aims to keep the kidney at or below 5°C for at least 60 minutes, potentially preventing harm and improving the success of the transplant. This is important because protecting the kidney during the procedure could help it function better after the transplant.

To participate in this study, individuals need to be at least 18 years old and scheduled to receive a single kidney from a deceased donor. It’s important that the donor has been confirmed as deceased through traditional methods, and the kidney must meet specific quality criteria. People who have had a previous kidney transplant, are receiving a kidney from a living donor, or have certain immune system conditions may not be eligible. If you qualify and choose to participate, you’ll be part of a process aimed at improving kidney transplant outcomes, which could benefit many patients in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. ≥18 years of age at time of transplant
  • 2. Slated to receive a single cadaveric organ
  • 3. Donor declared by traditional neurological determination of death (NDD)
  • 4. Standard criteria donor (SCD) or Extended criteria donor (ECD)
  • 5. Consent obtained prior to the transplant operation
  • Exclusion Criteria:
  • 1. Living donor (LD)
  • 2. Donor after cardiocirculatory death (DCD)
  • 3. Highly sensitized patients (those with Panel-reactive antibody or PRA \>80%)
  • 4. Recipient of a previous kidney transplant

About Thomas Skinner

Thomas Skinner is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on enhancing patient outcomes, the organization specializes in the design and management of clinical trials across various therapeutic areas. Leveraging a robust network of experienced professionals and a patient-centered approach, Thomas Skinner ensures rigorous adherence to regulatory standards while fostering collaboration among stakeholders. Their mission is to contribute to the development of safe and effective treatments, ultimately improving the quality of life for patients worldwide.

Locations

Halifax, Nova Scotia, Canada

Patients applied

0 patients applied

Trial Officials

Thomas Skinner

Principal Investigator

Nova Scotia Health Authority

Karthik Tennankore

Principal Investigator

Nova Scotia Health Authority

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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