Traumatic Brain Injury Clinical Trial
— EPO-TRAUMAOfficial title:
A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury
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.
Status | Recruiting |
Enrollment | 2500 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: Patients with trauma admitted to the ICU who: - 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 Exclusion Criteria: Patients will be excluded from the study if any of the following criteria apply: - 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Cairns Hospital | Cairns | Queensland |
Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
Australia | St Vincent's Hospital Sydney | Darlinghurst | New South Wales |
Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
Australia | St George Hospital | Kogarah | New South Wales |
Australia | Liverpool Hospital | Liverpool | New South Wales |
Australia | Royal Melbourne Hospital | Melbourne | Victoria |
Australia | The Alfred Hospital | Melbourne | Victoria |
Australia | John Hunter Hospital | New Lambton Heights | New South Wales |
Australia | Royal Perth Hospital | Perth | Western Australia |
Australia | Royal North Shore Hospital | Saint Leonards | New South Wales |
Australia | Gold Coast University Hospital | Southport | Queensland |
Australia | Royal Darwin Hospital | Tiwi | Northern Territory |
Australia | Westmead Hospital | Westmead | New South Wales |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
Finland | Helsinki University Hospital (HUS) | Helsinki | |
Finland | Kuopio University Hospital | Kuopio | |
Finland | Turku University Hospital | Turku | |
Germany | University Hospital Münster | Münster | |
Ireland | Beaumont Hospital | Beaumont | |
Ireland | Cork University Hospital | Cork | |
Ireland | St Vincent's University Hospital | Dublin | |
New Zealand | Middlemore Hospital | Auckland | Otahuhu |
New Zealand | Christchurch Hospital | Christchurch | |
New Zealand | Auckland City Hospital | Grafton | Auckland |
New Zealand | Waikato Hospital | Hamilton | Waikato |
New Zealand | Wellington Hospital | Newtown | Wellington |
Saudi Arabia | King Abdulaziz Medical City | Riyadh | |
Slovenia | University Medical Centre Ljubljana | Ljubljana | |
Slovenia | University Medical Centre Maribor | Maribor | |
Switzerland | University Hospital Bern | Bern | |
Switzerland | Lucerne Cantonal Hospital | Lucerne | |
Switzerland | St. Gallen Cantonal Hospital | Saint Gallen |
Lead Sponsor | Collaborator |
---|---|
Australian and New Zealand Intensive Care Research Centre | ANZICS Clinical Trials Group, Health Research Board, Ireland, Health Research Council, New Zealand, Irish Critical Care Clinical Trials Network, Medical Research Future Fund, Medical Research Institute of New Zealand, Monash University, University College Dublin |
Australia, Finland, Germany, Ireland, New Zealand, Saudi Arabia, Slovenia, Switzerland,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Combined proportion of participants who have died or have severe disability (WHODAS 2.0 > 25) | 6-months | ||
Secondary | Mortality at 6-months | 6 months | ||
Secondary | Mortality at ICU discharge | 6-months | ||
Secondary | Mortality at Hospital discharge | 6-months | ||
Secondary | Mortality at day 28 | 28 days | ||
Secondary | 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 | ||
Secondary | Proportion of participants with composite thrombotic vascular events (deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (PI), cardiac arrest and cerebrovascular events) at 6 months. | 6-months |
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