Actively Recruiting
ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients
Led by Australian and New Zealand Intensive Care Research Centre · Updated on 2025-07-16
2500
Participants Needed
41
Research Sites
355 weeks
Total Duration
On this page
Sponsors
A
Australian and New Zealand Intensive Care Research Centre
Lead Sponsor
U
University College Dublin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with trauma admitted to the ICU
- Age between 18 and 75 years
- Less than 24 hours since primary traumatic injury
- Receiving invasive mechanical ventilation
- Expected ICU stay of at least 48 hours
- Hemoglobin level not exceeding the upper limit of normal
- Informed consent from a legal surrogate according to local law
You will not qualify if you...
- Glasgow Coma Scale score of 3 with fixed dilated pupils
- Recent deep vein thrombosis, pulmonary embolism, or other thromboembolic event within 12 months or on anticoagulant treatment for these
- Chronic hypercoagulable disorder or known malignancy
- Treatment with erythropoietin in the last 30 days
- Unable to receive first dose of study drug within 24 hours of injury
- Pregnancy, lactation, or within 3 months postpartum
- Expected to die within 24 hours
- Known sensitivity to mammalian cell-derived products
- Known contraindication to epoetin alfa
- End stage renal failure requiring chronic dialysis
- Severe pre-existing physical or mental disability or severe co-morbidity interfering with outcome assessment
- Physician believes participation is not in patient's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 41 locations
1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
2
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Active, Not Recruiting
3
St George Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
4
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
5
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
Actively Recruiting
6
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia, 2065
Actively Recruiting
7
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
8
Royal Darwin Hospital
Tiwi, Northern Territory, Australia, 0810
Not Yet Recruiting
9
Cairns Hospital
Cairns, Queensland, Australia, 4870
Withdrawn
10
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Actively Recruiting
11
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
12
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
13
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
14
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
Not Yet Recruiting
15
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
16
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Actively Recruiting
17
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
18
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Not Yet Recruiting
19
HUB Hopital Erasme
Brussels, Belgium
Not Yet Recruiting
20
CHU-Charleroi Chimay
Charleroi, Belgium
Actively Recruiting
21
Ziekenhuis Oost-Limburg
Genk, Belgium
Not Yet Recruiting
22
Ghent University Hospital
Ghent, Belgium
Not Yet Recruiting
23
CHR de la Citadelle de LIEGE
Liège, Belgium
Not Yet Recruiting
24
Helsinki University Hospital (HUS)
Helsinki, Finland
Actively Recruiting
25
Kuopio University Hospital
Kuopio, Finland
Actively Recruiting
26
Turku University Hospital
Turku, Finland
Actively Recruiting
27
University Hospital Münster
Münster, Germany
Actively Recruiting
28
Beaumont Hospital
Beaumont, Ireland
Actively Recruiting
29
Cork University Hospital
Cork, Ireland
Actively Recruiting
30
St Vincent's University Hospital
Dublin, Ireland
Actively Recruiting
31
Auckland City Hospital
Grafton, Auckland, New Zealand, 1023
Actively Recruiting
32
Christchurch Hospital
Christchurch, Christchurch, New Zealand, 8011
Actively Recruiting
33
Middlemore Hospital
Auckland, Otahuhu, New Zealand, 1640
Actively Recruiting
34
Waikato Hospital
Hamilton, Waikato Region, New Zealand, 3204
Actively Recruiting
35
Wellington Hospital
Newtown, Wellington Region, New Zealand, 6021
Actively Recruiting
36
King Abdulaziz Medical City
Riyadh, Saudi Arabia
Actively Recruiting
37
University Medical Centre Ljubljana
Ljubljana, Slovenia
Actively Recruiting
38
University Medical Centre Maribor
Maribor, Slovenia
Actively Recruiting
39
University Hospital Bern
Bern, Switzerland
Actively Recruiting
40
Lucerne Cantonal Hospital
Lucerne, Switzerland
Not Yet Recruiting
41
St. Gallen Cantonal Hospital
Sankt Gallen, Switzerland
Actively Recruiting
Research Team
V
Vicki Papanikolaou
CONTACT
S
Sian Donnelly
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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