ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients
EPO-TRAUMA
A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury
3 other identifiers
interventional
2,500
9 countries
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2020
Longer than P75 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
November 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
July 16, 2025
July 1, 2025
6.1 years
October 1, 2020
July 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Combined proportion of participants who have died or have severe disability (WHODAS 2.0 > 25)
6-months
Secondary Outcomes (6)
Mortality at 6-months
6 months
Mortality at ICU discharge
6-months
Mortality at Hospital discharge
6-months
Mortality at day 28
28 days
Proportion of participants with a favourable Glasgow Outcome Score Extended (GOSE) (GOSE 5-8) compared to those have have died (GOSE 1), or have severe disability (GOSE 2-4).
6-months
- +1 more secondary outcomes
Study Arms (2)
Erythropoietin (EPO)
ACTIVE COMPARATOREpoetin alfa 40,000 IU (1mL pre-filled syringe) will be given by subcutaneous injection to eligible patients on Study Days 1 and 8 during the intensive care unit stay.
Placebo
PLACEBO COMPARATORSodium Chloride 0.9% (1mL in volume) will be given by subcutaneous injection to eligible patients allocated to the placebo arm on Study Days 1 and 8 during the intensive care unit stay.
Interventions
Epoetin alfa 40,000IU 1mL pre-filled syringe given as subcutaneous injection.
Sodium Chloride 0.9% 1mL in volume given as subcutaneous injection.
Eligibility Criteria
You may qualify if:
- Are ≥ 18 to ≤ 75 years of age
- Are \< 24 hours since primary traumatic injury
- Are invasively mechanically ventilated
- Are expected to stay in the ICU ≥ 48 hours
- Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution
- Have informed consent from a legal surrogate according to local law
You may not qualify if:
- GCS = 3 and fixed dilated pupils
- Recent history of DVT, PE or other thromboembolic event (within previous 12 months or receiving concomitant anticoagulant treatment for this indication)
- A chronic hypercoagulable disorder, including known malignancy
- Treatment with EPO in the last 30 days
- First dose of study drug unable to be given within 24 hours of primary injury
- Pregnancy or lactation or 3 months postpartum
- Expected to die imminently (\< 24 hours)
- Known sensitivity to mammalian cell derived products
- Known contraindication to epoetin alfa
- End stage renal failure (receives chronic dialysis)
- Severe pre-existing physical or mental disability or severe co-morbidity that may interfere with the assessment of outcome
- The treating physician believes it is not in the best interest of the patient to be randomised to this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Australian and New Zealand Intensive Care Research Centrelead
- University College Dublincollaborator
- Medical Research Institute of New Zealandcollaborator
- Medical Research Future Fundcollaborator
- Health Research Board, Irelandcollaborator
- Health Research Council, New Zealandcollaborator
- Irish Critical Care Clinical Trials Networkcollaborator
- ANZICS Clinical Trials Groupcollaborator
- Monash Universitycollaborator
Study Sites (41)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Darwin Hospital
Tiwi, Northern Territory, 0810, Australia
Cairns Hospital
Cairns, Queensland, 4870, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Adelaide, South Australia, 5042, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, 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, 1023, New Zealand
Christchurch Hospital
Christchurch, Christchurch, 8011, New Zealand
Middlemore Hospital
Auckland, Otahuhu, 1640, New Zealand
Waikato Hospital
Hamilton, Waikato Region, 3204, New Zealand
Wellington Hospital
Newtown, Wellington Region, 6021, 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
Related Publications (1)
Nichol A, French C, Little L, Haddad S, Presneill J, Arabi Y, Bailey M, Cooper DJ, Duranteau J, Huet O, Mak A, McArthur C, Pettila V, Skrifvars M, Vallance S, Varma D, Wills J, Bellomo R; EPO-TBI Investigators; ANZICS Clinical Trials Group. Erythropoietin in traumatic brain injury (EPO-TBI): a double-blind randomised controlled trial. Lancet. 2015 Dec 19;386(10012):2499-506. doi: 10.1016/S0140-6736(15)00386-4. Epub 2015 Oct 6.
PMID: 26452709BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Associate Professor Craig French
Western Health; ANZIC Research Centre
- STUDY CHAIR
Professor Alistair Nichol
University College Dublin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2020
First Posted
October 19, 2020
Study Start
November 9, 2020
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
July 16, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- As per the ANZIC Research Centre Data Sharing Policy
- Access Criteria
- As per the ANZIC Research Centre Data Sharing Policy
At the conclusion of the study, the study management committee will consider requests from researchers who provide a methodically sound scientific proposal as per the Data Sharing Policy set out in the ANZIC-RC Terms of Reference.