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

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.

Conditions

• Trauma
• Traumatic Injury
• Traumatic Brain Injury
• Wounds and Injuries
• Penetrating Injury
• Blunt Injury
• Major Trauma
• Multiple Trauma

Interventions

DRUG

Epoetin Alfa 40000 UNT/ML

Epoetin alfa 40,000IU 1mL pre-filled syringe given as subcutaneous injection.

DRUG

Sodium Chloride 0.9%

Sodium Chloride 0.9% 1mL in volume given as subcutaneous injection.

Sponsors & Collaborators

• University College Dublin

  collaborator OTHER

• Medical Research Institute of New Zealand

  collaborator OTHER

• Medical Research Future Fund

  collaborator OTHER

• Health Research Board, Ireland

  collaborator OTHER

• Health Research Council, New Zealand

  collaborator OTHER

• Irish Critical Care Clinical Trials Network

  collaborator UNKNOWN

• ANZICS Clinical Trials Group

  collaborator NETWORK

• Monash University

  collaborator OTHER

• Australian and New Zealand Intensive Care Research Centre

  lead OTHER

Principal Investigators

• Associate Professor Craig French · Western Health; ANZIC Research Centre

• Professor Alistair Nichol · University College Dublin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-09

Primary Completion

2026-12-31

Completion

2027-08-31

Countries

• Australia
• Belgium
• Finland
• Germany
• Ireland
• New Zealand
• Saudi Arabia
• Slovenia
• Switzerland

Study Locations