Kidney Protective Jacket to keep donated kidneys cool during transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a safety-focused interventional study using the Kidney Protective Jacket (KPJ) during kidney transplantation to limit re-warming of the organ during the anastomosis phase. The device is applied to donated kidneys removed from cold storage and is intended to reduce second warm ischemic time-related temperature rise that contributes to ischemia-reperfusion injury. The study will include suitable deceased and living donor kidneys transplanted into consenting adults (age ≥18) undergoing their first or second transplant, with exclusions for pediatric donor kidneys and silicone allergy. Investigators aim to use the device across a range of anatomical and procedural scenarios (single/multiple renal vessels, varying kidney sizes and recipient body sizes) to document safety in typical clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All deceased and living donor kidneys that are deemed suitable for transplantation
* All suitable recipients who are 18 years or greater, and undergoing their first or second kidney transplant
* All recipients must be able to provide full informed consent

Exclusion Criteria:

* Paediatric donor kidneys (kidneys from donors \< 16 years in age)
* Patients with a known allergy or hypersensitivity to silicone

Where it's running

• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Amy Hort, MBBS (HONS), MS, FRACS
• Email: amy.hort@health.nsw.gov.au
• Phone: +61432782850

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treating blood vessel problems after a kidney transplant

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.