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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04588311
Other study ID # ANZIC-RC/CF001
Secondary ID U1111-1242-36942
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 9, 2020
Est. completion date December 31, 2025

Study information

Verified date October 2023
Source Australian and New Zealand Intensive Care Research Centre
Contact Vicki Papanikolaou
Phone +61 409 142 695
Email vicki.papanikolaou@monash.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Trauma can cause many injuries, some of which are life-threatening and require treatment in an intensive care unit (ICU). Despite best available treatment and therapies, people who sustain a critical traumatic injury are at greater risk of death or long-term disability. From 2010 to 2015, approximately 9% of people admitted to an ICU in Australia and New Zealand for treatment of their injuries, did not survive. In Victoria, 6-months post injury, approximately 31% of people who were critically injured developed severe disabilities or died. 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
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.

Locations

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

Sponsors (9)

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

Countries where clinical trial is conducted

Australia,  Finland,  Germany,  Ireland,  New Zealand,  Saudi Arabia,  Slovenia,  Switzerland, 

References & 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 — View Citation

Outcome

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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