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The RENAL Assessment of EPO-TBI

ANZICS CTG Endorsed Study

The RENAL Assessment of EPO-TBI

Study Description

Taking advantage of the unique opportunity offered by the EPO TBI multicentre randomised controlled trial of erythropoietin (EPO) in traumatic brain injury (TBI), this substudy will investigate whether in patients with TBI: a) EPO reduces the severity, incidence, and duration of Acute Kidney Injury (AKI); b) the release of kidney injury biomarkers including NGAL will be reduced by EPO compared to those receiving placebo; c) the release of kidney injury biomarkers including NGAL will predict the occurrence, severity and duration of AKI in patients with TBI.

The EPO-TBI study provides the opportunity to evaluate the benefit of EPO as a treatment for AKI. If it is found to be beneficial, this could justify dedicated investigation of this intervention in critically ill patients at risk of AKI. Study of the biomarkers will provide unprecedented insight into their release and performance as markers of AKI and their response to therapy.

Management Committee

Elizabeth Moore (Chair / Project Manager), Michael Bailey, Rinaldo Bellomo, and Alistair Nichol.

Administering Institution

ANZIC Research Centre, Monash University

Collaborators

Robert Atkins

Sample Size

606 patients – EPO-AKI; 30 patients – EPO-Biomarkers

Funding

Intensive Care Foundation (joint funding for EPO-TBI and POLAR renal substudies) $13,553.

Project Status as of June 2018

The first manuscript is close to submission.

Contact

Elizabeth Moore (mail)

Reference

CTG1718-06
NCT00987454 (EPO-TBI Study)
ACTRN12609000827235 (EPO-TBI Study)
EUDRA CT: 2011 – 005235 – 22 (EPO-TBI Study)