A randomised, double-blind, placebo-controlled trial of erythropoietin alfa versus placebo in mechanically ventilated critically ill patients following traumatic injury

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506081-31-00

Acronym

UCDCRC/20/04

Enrollment

1243

Registered

2024-05-17

Start date

2022-03-29

Completion date

Unknown

Last updated

2025-08-12

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

Conditions

Traumatic Injury

Brief summary

Combination of Mortality and Severe Disability (defined as a WHODAS 2.0 score ≥25%) at six months

Detailed description

Six Month Mortality, ICU Mortality, Hospital Mortality, 28 Day Mortality, Dichotomised extended Glasgow Outcome Score Extended (GOSE) into favourable (i.e. >4) and unfavourable (i.e. <4) outcomes at six months, Proportion of participants with composite thrombotic vascular events (DVT, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at 6 months.

Interventions

DRUGEPREX 40000 UI/ml

DRUGsolution injectable en seringue préremplie

DRUGEpoetin alfa HEXAL 40

DRUG000 IU/1 mL solution for injection in a pre-filled syringe

DRUGBinocrit 40

DRUG-

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Combination of Mortality and Severe Disability (defined as a WHODAS 2.0 score ≥25%) at six months	—

Secondary

Measure	Time frame
Six Month Mortality, ICU Mortality, Hospital Mortality, 28 Day Mortality, Dichotomised extended Glasgow Outcome Score Extended (GOSE) into favourable (i.e. >4) and unfavourable (i.e. <4) outcomes at six months, Proportion of participants with composite thrombotic vascular events (DVT, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at 6 months.	—

Countries

Belgium, Finland, France, Germany, Ireland, Slovenia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026