ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients (EPO-TRAUMA)

A randomised, double blind, placebo-controlled trial to determine the effect of erythropoietin alfa compared with placebo on death and severe disability in mechanically ventilated critically ill patients following traumatic injury.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001632189

Acronym

EPO TRAUMA

Enrollment

870

Registered

2019-11-25

Start date

2020-11-25

Completion date

2026-12-31

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Prior research strongly suggests that the drug epoetin alfa improves the outcome of critically ill trauma patients. If proven correct, this has important implications for the management of trauma patients throughout the world.. We will conduct an international multi-centre trial in critically ill trauma patients that will determine the effect epoetin alfa on the rate of death and severe disability.

Interventions

Epoetin alfa 40,000IU subcutaneously administered within 24 hours of injury. Additional dose of study a drug administered on Day 8 if none of the withholding criteria are met. Study drug is withheld if the Hb concentration is greater than 120 g/L. Intervention will be in major hospitals.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

a) Are greater or equal to 18 to less than or equal to 75 years of age b) Are < 24 hours since primary traumatic injury c) Are invasively mechanically ventilated d) Are expected to stay in the ICU >= 48 hours e) Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution f) Have informed consent from a legal surrogate according to local law

Exclusion criteria

a) GCS = 3 and fixed dilated pupils b) Recent history of DVT, PE or other thromboembolic event (within previous 12 months or receiving concomitant anticoagulant treatment for this indication) c) A chronic hypercoagulable disorder, including known malignancy d) Treatment with EPO in the last 30 days e) First dose of study drug unable to be given within 24 hours of primary injury f) Pregnancy or lactation or 3 months post-partum g) Expected to die imminently (< 24 hours) h) Known sensitivity to mammalian cell derived products i) Known contraindication to epoetin alfa j) End stage renal failure (receives chronic dialysis) k) Severe pre-existing physical or mental disability or severe co-morbidity that may interfere with the assessment of outcome l) The treating physician believes it is not in the best interest of the patient to be randomised to this trial

Outcome results