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Clinical Trials in Germany / NCT04588311
Recruiting Phase 3

ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients

NCT04588311 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2020-11-09
Last updated
2025-07-16

Condition(s) studied

TraumaTraumatic InjuryTraumatic Brain InjuryWounds and InjuriesPenetrating InjuryBlunt InjuryMajor TraumaMultiple Trauma

Investigational drug(s) / intervention(s)

Epoetin Alfa 40000 UNT/ML →Sodium Chloride 0.9%

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Royal Prince Alfred Hospital Camperdown New South Wales Recruiting
St Vincent's Hospital Sydney Darlinghurst New South Wales Active Not Recruiting
St George Hospital Kogarah New South Wales Recruiting
Liverpool Hospital Liverpool New South Wales Recruiting
John Hunter Hospital New Lambton Heights New South Wales Recruiting
Royal North Shore Hospital Saint Leonards New South Wales Recruiting
Westmead Hospital Westmead New South Wales Recruiting
Royal Darwin Hospital Tiwi Northern Territory Not Yet Recruiting
Cairns Hospital Cairns Queensland Withdrawn
Royal Brisbane and Women's Hospital Herston Queensland Recruiting
Gold Coast University Hospital Southport Queensland Recruiting
Princess Alexandra Hospital Woolloongabba Queensland Recruiting
Royal Adelaide Hospital Adelaide South Australia Recruiting
Flinders Medical Centre Adelaide South Australia Not Yet Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
Royal Melbourne Hospital Melbourne Victoria Recruiting
Royal Perth Hospital Perth Western Australia Recruiting
Cliniques Universitaires Saint-Luc Brussels Belgium Not Yet Recruiting
HUB Hopital Erasme Brussels Belgium Not Yet Recruiting
CHU-Charleroi Chimay Charleroi Belgium Recruiting
Ziekenhuis Oost-Limburg Genk Belgium Not Yet Recruiting
Ghent University Hospital Ghent Belgium Not Yet Recruiting
CHR de la Citadelle de LIEGE Liège Belgium Not Yet Recruiting
Helsinki University Hospital (HUS) Helsinki Finland Recruiting
Kuopio University Hospital Kuopio Finland Recruiting
Turku University Hospital Turku Finland Recruiting
University Hospital Münster Münster Germany Recruiting
Beaumont Hospital Beaumont Ireland Recruiting
Cork University Hospital Cork Ireland Recruiting
St Vincent's University Hospital Dublin Ireland Recruiting
Auckland City Hospital Grafton Auckland Recruiting
Christchurch Hospital Christchurch Christchurch Recruiting
Middlemore Hospital Auckland Otahuhu Recruiting
Waikato Hospital Hamilton Waikato Region Recruiting
Wellington Hospital Newtown Wellington Region Recruiting
King Abdulaziz Medical City Riyadh Saudi Arabia Recruiting
University Medical Centre Ljubljana Ljubljana Slovenia Recruiting
University Medical Centre Maribor Maribor Slovenia Recruiting
University Hospital Bern Bern Switzerland Recruiting
Lucerne Cantonal Hospital Lucerne Switzerland Not Yet Recruiting

+ 1 more sites — see the full list on the official registry below.

More Australian and New Zealand Intensive Care Research Centre trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04588311 on ClinicalTrials.gov ↗ ← All trials in Germany