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RECRUITING
NCT04588311
PHASE3

ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients

Sponsor: Australian and New Zealand Intensive Care Research Centre

View on ClinicalTrials.gov

Summary

The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients. 2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.

Official title: A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2020-11-09

Completion Date

2027-08-31

Last Updated

2025-07-16

Healthy Volunteers

No

Interventions

DRUG

Epoetin Alfa 40000 UNT/ML

Epoetin alfa 40,000IU 1mL pre-filled syringe given as subcutaneous injection.

DRUG

Sodium Chloride 0.9%

Sodium Chloride 0.9% 1mL in volume given as subcutaneous injection.

Locations (41)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Royal Darwin Hospital

Tiwi, Northern Territory, Australia

Cairns Hospital

Cairns, Queensland, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Adelaide, South Australia, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Cliniques Universitaires Saint-Luc

Brussels, Belgium

HUB Hopital Erasme

Brussels, Belgium

CHU-Charleroi Chimay

Charleroi, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

Ghent University Hospital

Ghent, Belgium

CHR de la Citadelle de LIEGE

Liège, Belgium

Helsinki University Hospital (HUS)

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Turku University Hospital

Turku, Finland

University Hospital Münster

Münster, Germany

Beaumont Hospital

Beaumont, Ireland

Cork University Hospital

Cork, Ireland

St Vincent's University Hospital

Dublin, Ireland

Auckland City Hospital

Grafton, Auckland, New Zealand

Christchurch Hospital

Christchurch, Christchurch, New Zealand

Middlemore Hospital

Auckland, Otahuhu, New Zealand

Waikato Hospital

Hamilton, Waikato Region, New Zealand

Wellington Hospital

Newtown, Wellington Region, New Zealand

King Abdulaziz Medical City

Riyadh, Saudi Arabia

University Medical Centre Ljubljana

Ljubljana, Slovenia

University Medical Centre Maribor

Maribor, Slovenia

University Hospital Bern

Bern, Switzerland

Lucerne Cantonal Hospital

Lucerne, Switzerland

St. Gallen Cantonal Hospital

Sankt Gallen, Switzerland