ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients
NCT ID: NCT04588311
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2500 participants
INTERVENTIONAL
2020-11-09
2027-08-31
Brief Summary
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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.
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Detailed Description
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Following a traumatic injury, a number of complex pathways are activated by the body. These pathways can occur over hours or weeks and may lead to damage of cells, tissues or blood vessels and may destroy other healthy tissue. The treatment of traumatic injury focuses on trying to minimise further damage that can occur after the initial injury.
Erythropoietin is a glycoprotein hormone essential for erythropoiesis and was first purified in 1977. Its human recombinant analogues known as erythropoiesis stimulating agents (ESAs) are approved for human therapeutic use. However, erythropoietin is also a pleiotropic cytokine with effects beyond just erythropoiesis. Studies in animals have demonstrated the potential protective effects of erythropoietin to organs including the brain, kidney, liver and heart, and anti-inflammatory properties.
Previous research suggests the use of the ESA called epoetin alfa, increases the number of patients surviving severe trauma and reduces the risk of disability in those who survive.
The primary aim of the study is to determine 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Erythropoietin (EPO)
Epoetin 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.
Epoetin Alfa 40000 UNT/ML
Epoetin alfa 40,000IU 1mL pre-filled syringe given as subcutaneous injection.
Placebo
Sodium 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.
Sodium Chloride 0.9%
Sodium Chloride 0.9% 1mL in volume given as subcutaneous injection.
Interventions
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Epoetin Alfa 40000 UNT/ML
Epoetin alfa 40,000IU 1mL pre-filled syringe given as subcutaneous injection.
Sodium Chloride 0.9%
Sodium Chloride 0.9% 1mL in volume given as subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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University College Dublin
OTHER
Medical Research Institute of New Zealand
OTHER
Medical Research Future Fund
OTHER
Health Research Board, Ireland
OTHER
Health Research Council, New Zealand
OTHER
Irish Critical Care Clinical Trials Network
UNKNOWN
ANZICS Clinical Trials Group
NETWORK
Monash University
OTHER
Australian and New Zealand Intensive Care Research Centre
OTHER
Responsible Party
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Principal Investigators
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Associate Professor Craig French
Role: STUDY_CHAIR
Western Health; ANZIC Research Centre
Professor Alistair Nichol
Role: STUDY_CHAIR
University College Dublin
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Prof Michael Piagnerelli
Role: primary
References
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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.
Other Identifiers
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U1111-1242-3694
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-003388-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANZIC-RC/CF001
Identifier Type: -
Identifier Source: org_study_id
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