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

PHASE3RECRUITING

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.

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Study details:

Trauma can cause many injuries, some of which are life-threatening and require treatment in an intensive care unit (ICU). Despite best available treatment and therapies, people who sustain a critical traumatic injury are at greater risk of death or long-term disability. From 2010 to 2015, approximately 9% of people admitted to an ICU in Australia and New Zealand for treatment of their injuries, did not survive.

In Victoria, 6-months post injury, approximately 31% of people who were critically injured developed severe disabilities or died. Following a traumatic injury, a number of complex pathways are activated by the body. These pathways can occur over hours or weeks and may lead to damage of cells, tissues or blood vessels and may destroy other healthy tissue.

The treatment of traumatic injury focuses on trying to minimise further damage that can occur after the initial injury. Erythropoietin is a glycoprotein hormone essential for erythropoiesis and was first purified in 1977. Its human recombinant analogues known as erythropoiesis stimulating agents (ESAs) are approved for human therapeutic use.

However, erythropoietin is also a pleiotropic cytokine with effects beyond just erythropoiesis. Studies in animals have demonstrated the potential protective effects of erythropoietin to organs including the brain, kidney, liver and heart, and anti-inflammatory properties. Previous research suggests the use of the ESA called epoetin alfa, increases the number of patients surviving severe trauma and reduces the risk of disability in those who survive.

The primary aim of the study is to determine 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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-11-09

Primary completion: 2025-12-31

Study completion finish: 2025-12-31

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT04588311

Intervention or treatment

DRUG: Epoetin Alfa 40000 UNT/ML

DRUG: Sodium Chloride 0.9%

Conditions

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

Condition: Trauma, Traumatic Injury and more
DRUG: Epoetin Alfa 40000 UNT/ML and other drugs
Camperdown, New South Wales, Australia and more
Sponsor: Australian and New Zealand Intensive Care Research Centre

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Prince Alfred Hospital

Research sites nearby

Select from list below to view details:

Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Erythropoietin (EPO) Epoetin alfa 40,000 IU (1mL pre-filled syringe) will be given by subcutaneous injection to eligible patients on Study Days 1 and 8 during the intensive care unit stay.	DRUG: Epoetin Alfa 40000 UNT/ML Epoetin alfa 40,000IU 1mL pre-filled syringe given as subcutaneous injection.
PLACEBO_COMPARATOR: Placebo Sodium Chloride 0.9% (1mL in volume) will be given by subcutaneous injection to eligible patients allocated to the placebo arm on Study Days 1 and 8 during the intensive care unit stay.	DRUG: Sodium Chloride 0.9% Sodium Chloride 0.9% 1mL in volume given as subcutaneous injection.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Combined proportion of participants who have died or have severe disability (WHODAS 2.0 > 25)	Not Specified	6-months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Mortality at 6-months	Not Specified	6 months
Mortality at ICU discharge	Not Specified	6-months
Mortality at Hospital discharge	Not Specified	6-months
Mortality at day 28	Not Specified	28 days
Proportion of participants with a favourable Glasgow Outcome Score Extended (GOSE) (GOSE 5-8) compared to those have have died (GOSE 1), or have severe disability (GOSE 2-4).	Not Specified	6-months
Proportion of participants with composite thrombotic vascular events (deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (PI), cardiac arrest and cerebrovascular events) at 6 months.	Not Specified	6-months

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients