Last updated on March 2020

EPI-STORM: Cytokine Storm in Organ Donors


Brief description of study

Liver transplant is the main treatment and also the last proposed to patients affected by end-stage liver disease. Over 70% of available livers are obtained from organ donors after neurologic death. Unfortunately, 20% of available organs for donation are considered improper and will never be transplanted. When neurologic death occurs, a reaction is generated by the immune system, the system that fights infections. This reaction release substances in the blood that could harm organs and particularly the liver.

Detailed Study Description

Severe neurological injuries such as those observed in neurologically deceased donors (i.e. brain death) trigger a massive cytokine release causing organ injury and affecting the number and quality of all transplanted organs, but particularly the liver. In recipients, elevated serum levels of TNF- are associated with graft dysfunction. In donors, this association is unknown. Equally important, current models of graft injury fail to consider the epigenetic effects of physiological stressors that occurred in neurologically deceased donors. As an example, alterations in the expression profile of miRNA-155 have been observed in liver transplantation. The investigators hypothesize that in donors, peak plasma levels of pro-inflammatory cytokines and their associated miRNA (between consent and recovery) asTNF-a, are associated with a lower probability of liver recovery for transplantation and elevated graft dysfunction in recipients. The investigators propose a prospective cohort study with the main objective of validating the impact of organ donor proinflammatory markers. Samples will be collected at different time points in neurologically deceased candidate liver donors in 3 centres. Addressing an important need for the participants, the results will establish a physiological rational for new therapeutic targets in organ donors and the understanding of the contribution of epigenetics to liver graft function will lead to more personalized medicine approaches.

Clinical Study Identifier: NCT03786991

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