UnknownNot Applicable

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

Canada45 participantsStarted 2023-10-01

Plain-language summary

Avoiding warm ischemia time during vascular anastomosis of the renal allograft is important to prevent damage. The investigators are studying a cooling device that may control the temperature of the renal allograft during transplant surgery; attempting to keep temperatures at or below 5°C for at least 60 minutes. If found effective, this could eliminate warm ischemia and potentially prevent damage to transplanted kidneys.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥18 years of age at time of transplant
✓. Slated to receive a single cadaveric organ
✓. Donor declared by traditional neurological determination of death (NDD)
✓. Standard criteria donor (SCD) or Extended criteria donor (ECD)
✓. Consent obtained prior to the transplant operation

Exclusion criteria

✕. Living donor (LD)
✕. Donor after cardiocirculatory death (DCD)
✕. Highly sensitized patients (those with Panel-reactive antibody or PRA \>80%)
✕. Recipient of a previous kidney transplant

What they're measuring

Part A: Device design is deemed suitable to move into the traditional feasibility stage (Part B of protocol)

Timeframe: 6 months

Part B: To determine the feasibility of a trial using the Kidney Skinn cooling device to usual care to ameliorate warm ischemia time during kidney transplantation

Timeframe: 2 years

Trial details

NCT IDNCT05166460

SponsorThomas Skinner

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-15

Contact for this trial

Thomas Skinner

902-425-3940 tomaaskinner@gmail.com

View on ClinicalTrials.gov More Kidney Transplant; Complications trials