Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Australian and New Zealand Intensive Care Research Centre
Registry number NCT04588311
Started 9 November 2020 Today 16 October 2026 Estimated completion 31 December 2026

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Royal Prince Alfred Hospital Camperdown NSW Recruiting
St Vincent's Hospital Sydney Darlinghurst NSW Active not recruiting
St George Hospital Kogarah NSW Recruiting
Liverpool Hospital Liverpool NSW Recruiting
John Hunter Hospital New Lambton Heights NSW Recruiting
Royal North Shore Hospital Saint Leonards NSW Recruiting
Westmead Hospital Westmead NSW Recruiting
Royal Darwin Hospital Tiwi NT Not yet recruiting
Cairns Hospital Cairns QLD Withdrawn
Royal Brisbane and Women's Hospital Herston QLD Recruiting
Gold Coast University Hospital Southport QLD Recruiting
Princess Alexandra Hospital Woolloongabba QLD Recruiting
Royal Adelaide Hospital Adelaide SA Recruiting
Flinders Medical Centre Adelaide SA Not yet recruiting
The Alfred Hospital Melbourne VIC Recruiting
Royal Melbourne Hospital Melbourne VIC Recruiting
Royal Perth Hospital Perth WA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years to 75 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 2500

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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

Dates on the record

Started 9 November 2020
Estimated completion 31 December 2026
Registry last updated 16 July 2025
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 16 July 2025.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.