Remote Ischemic Preconditioning in Neurological Death Organ Donors

Completed · Not applicable

Conditions studied: Organ Transplantation

In brief

The purpose of this study is to determine whether application of lower limb remote ischemic preconditioning (RIPC) after determination of brain death improves donor stability, organ quality, organ yield, and early post transplant clinical outcomes. Neurological death donors will be stratified into standard and extended criteria donors (SCD/ECD) and randomized in a 1:1 fashion to RIPC or No intervention. The primary outcome is the number of organs recovered per donor. Secondary outcomes include donor hemodynamic state, donor organ-specific function parameters, pulsatile perfusion parameters, number of organs transplanted per donor, recipient hospital free survival and delayed graft function of kidneys. The sample size is powered to detect a difference of 0.44 organs recovered.

Key facts

Study ID

NCT01515072

Run by

Rutgers, The State University of New Jersey

People needed

321

Starts

2011-07-01

Expected to finish

2015-04-01

Last updated by the study team

2018-12-19

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neurological death donors in whom brain death determination is imminent
• First person consent or next of kin consent for research
• Donors >=6 years of age
• Organ recovery not expected within 6 hours of consent.
• Both sexes and ethnicities.

You may not qualify if…

• Donation after cardiac death donors (DCD)
• Live organ donors
• No first person consent and next of kin decline research consent
• Donor Age < 6 years
• Lower extremity trauma or recent amputation
• Tissue only donors

Where it is running

• Rutgers, The State University of New Jersey — Newark, New Jersey, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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