RecruitingPhase 3ACTRN12619001632189

ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients (EPO-TRAUMA)

A randomised, double blind, placebo-controlled trial to determine the effect of erythropoietin alfa compared with placebo on death and severe disability in mechanically ventilated critically ill patients following traumatic injury.


Sponsor

Monash University

Enrollment

2,500 participants

Start Date

Nov 25, 2020

Study Type

Interventional

Conditions

Summary

Prior research strongly suggests that the drug epoetin alfa improves the outcome of critically ill trauma patients. If proven correct, this has important implications for the management of trauma patients throughout the world.. We will conduct an international multi-centre trial in critically ill trauma patients that will determine the effect epoetin alfa on the rate of death and severe disability.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Trauma — such as serious car accidents, falls, or other major injuries — is a leading cause of death and long-term disability worldwide. Critically injured patients who need to be put on a breathing machine (mechanical ventilation) in the intensive care unit (ICU) are at high risk of complications. Despite advances in trauma care, many patients still die or survive with severe disabilities. Epoetin alfa (also known as erythropoietin) is a medication that stimulates the production of red blood cells. Research has suggested it may have broader protective effects on the body beyond just making blood cells — including protecting organs and potentially improving survival in critically ill patients. The EPO-TRAUMA trial is an international study testing whether giving epoetin alfa to critically ill trauma patients reduces the rate of death and severe disability. You may be eligible if you are aged 18–75, have been critically injured within the last 24 hours, require mechanical ventilation in the ICU, and are expected to remain in the ICU for at least 48 hours. Because this is an emergency situation, consent may be provided by a legal representative. Patients with a history of blood clots, those already on blood-thinning medications, pregnant patients, or those expected to die within 24 hours would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Epoetin alfa 40,000IU subcutaneously administered within 24 hours of injury. Additional dose of study a drug administered on Day 8 if none of the withholding criteria are met. Study drug is withheld i

Epoetin alfa 40,000IU subcutaneously administered within 24 hours of injury. Additional dose of study a drug administered on Day 8 if none of the withholding criteria are met. Study drug is withheld if the Hb concentration is greater than 120 g/L. Intervention will be in major hospitals.


Locations(25)

The Alfred - Melbourne

NSW,QLD,SA,WA,VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

NSW,QLD,SA,WA,VIC, Australia

Royal Prince Alfred Hospital - Camperdown

NSW,QLD,SA,WA,VIC, Australia

John Hunter Hospital - New Lambton

NSW,QLD,SA,WA,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,SA,WA,VIC, Australia

St George Hospital - Kogarah

NSW,QLD,SA,WA,VIC, Australia

Gold Coast University Hospital - Southport

NSW,QLD,SA,WA,VIC, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD,SA,WA,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,SA,WA,VIC, Australia

Liverpool Hospital - Liverpool

NSW,QLD,SA,WA,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,QLD,SA,WA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,QLD,SA,WA,VIC, Australia

Royal Perth Hospital - Perth

NSW,QLD,SA,WA,VIC, Australia

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW,QLD,SA,WA,VIC, Australia

Royal Darwin Hospital - Tiwi

NSW,QLD,SA,WA,VIC, Australia

Flinders Medical Centre - Bedford Park

NSW,QLD,SA,WA,VIC, Australia

Finland

Ireland

New Zealand

Slovenia

Saudi Arabia

Bern, Switzerland

Berlin, Germany

France

Brussels, Belgium

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