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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04588311




Registration number
NCT04588311
Ethics application status
Date submitted
1/10/2020
Date registered
19/10/2020
Date last updated
3/10/2023

Titles & IDs
Public title
ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients
Scientific title
A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury
Secondary ID [1] 0 0
U1111-1242-3694
Secondary ID [2] 0 0
ANZIC-RC/CF001
Universal Trial Number (UTN)
Trial acronym
EPO-TRAUMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma 0 0
Traumatic Injury 0 0
Traumatic Brain Injury 0 0
Wounds and Injuries 0 0
Penetrating Injury 0 0
Blunt Injury 0 0
Major Trauma 0 0
Multiple Trauma 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Epoetin Alfa 40000 UNT/ML
Treatment: Drugs - Sodium Chloride 0.9%

Active comparator: 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.

Placebo comparator: 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.


Treatment: Drugs: Epoetin Alfa 40000 UNT/ML
Epoetin alfa 40,000IU 1mL pre-filled syringe given as subcutaneous injection.

Treatment: Drugs: Sodium Chloride 0.9%
Sodium Chloride 0.9% 1mL in volume given as subcutaneous injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Combined proportion of participants who have died or have severe disability (WHODAS 2.0 > 25)
Timepoint [1] 0 0
6-months
Secondary outcome [1] 0 0
Mortality at 6-months
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Mortality at ICU discharge
Timepoint [2] 0 0
6-months
Secondary outcome [3] 0 0
Mortality at Hospital discharge
Timepoint [3] 0 0
6-months
Secondary outcome [4] 0 0
Mortality at day 28
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
6-months
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
6-months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
2500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [6] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [9] 0 0
Cairns Hospital - Cairns
Recruitment hospital [10] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [11] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [12] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [13] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [14] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [15] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [16] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [6] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
0810 - Tiwi
Recruitment postcode(s) [9] 0 0
4870 - Cairns
Recruitment postcode(s) [10] 0 0
4029 - Herston
Recruitment postcode(s) [11] 0 0
4215 - Southport
Recruitment postcode(s) [12] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [13] 0 0
5000 - Adelaide
Recruitment postcode(s) [14] 0 0
3004 - Melbourne
Recruitment postcode(s) [15] 0 0
3050 - Melbourne
Recruitment postcode(s) [16] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Helsinki
Country [2] 0 0
Finland
State/province [2] 0 0
Kuopio
Country [3] 0 0
Finland
State/province [3] 0 0
Turku
Country [4] 0 0
Germany
State/province [4] 0 0
Münster
Country [5] 0 0
Ireland
State/province [5] 0 0
Beaumont
Country [6] 0 0
Ireland
State/province [6] 0 0
Cork
Country [7] 0 0
Ireland
State/province [7] 0 0
Dublin
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
New Zealand
State/province [9] 0 0
Otahuhu
Country [10] 0 0
New Zealand
State/province [10] 0 0
Waikato
Country [11] 0 0
New Zealand
State/province [11] 0 0
Wellington
Country [12] 0 0
New Zealand
State/province [12] 0 0
Christchurch
Country [13] 0 0
Saudi Arabia
State/province [13] 0 0
Riyadh
Country [14] 0 0
Slovenia
State/province [14] 0 0
Ljubljana
Country [15] 0 0
Slovenia
State/province [15] 0 0
Maribor
Country [16] 0 0
Switzerland
State/province [16] 0 0
Bern
Country [17] 0 0
Switzerland
State/province [17] 0 0
Lucerne
Country [18] 0 0
Switzerland
State/province [18] 0 0
Saint Gallen

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University College Dublin
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Medical Research Institute of New Zealand
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Medical Research Future Fund
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Health Research Board, Ireland
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Health Research Council, New Zealand
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Irish Critical Care Clinical Trials Network
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
ANZICS Clinical Trials Group
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Monash University
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT04588311
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
A/Professor Craig French
Address 0 0
Western Health; ANZIC Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vicki Papanikolaou
Address 0 0
Country 0 0
Phone 0 0
+61 409 142 695
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04588311