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Erythropoietin in Traumatic Brain Injury (EPO-TBI)

Information source: Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Traumatic Brain Injury

Intervention: Epoetin Alfa (Drug); Sodium Chloride 0.9% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Australian and New Zealand Intensive Care Research Centre

Official(s) and/or principal investigator(s):
Alistair D Nichol, MD, Study Chair, Affiliation: Monash University

Summary

This study seeks to determine if erythropoietin alpha (EPO) administered to adult critical care patients with moderate or severe traumatic brain injury improves neurological function assessed at six months after injury.

Clinical Details

Official title: A Randomised, Placebo-controlled Trial of Erythropoietin in ICU Patients With Traumatic Brain Injury

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Combined proportion of unfavourable neurological outcomes at 6 months: severe disability (defined as GOSE scores 2-4) or death (GOSE score 1).

Secondary outcome:

Probability of an equal or greater Glasgow Coma Scale Extended (GOSE) level at 6 months compared to the probability of a lesser GOSE level, using a proportional odds model

Proportion of surviving patients with unfavourable neurological outcome (GOSE 2-4) at 6 months

Quality of life assessment (SF-12 and EQ-5D) at 6 months

Mortality at 6 months

Rate of proximal deep venous thrombosis detected during screening by compression Doppler ultrasound

Proportion of patients with composite thrombotic vascular events (DVT, pulmonary embolus, myocardial infarction, cardiac arrest and cerebrovascular events) at 6 months

Cost effectiveness analysis at 6 months (based on EQ-5D)

Detailed description:

Many people who have a traumatic brain injury (TBI) - usually from a blow to the head such

as in a vehicle collision or in a fall do not survive or, if they do, suffer from long-term disability. Previous studies have shown that about 1,000 people in Australia and New Zealand suffer a moderate or severe TBI every year. With current best available treatment and therapies many of these patients sustain loss of brain function and long term disability in varying degrees. When a patient sustains a traumatic brain injury there are two phases to the injury. First, the head-impact causes immediate damage to the brain. The secondary injury, which can evolve over hours or weeks, is a very complicated process. It involves many, linked, changes to the cells, brain chemistry, tissues or blood vessels that can destroy brain tissue. The treatment of brain injury focuses on trying to minimize the secondary injury and there is much research being done to try to find treatments that will prevent it. Erythropoietin (EPO) has recently emerged as a drug that may help reduce secondary injury and improve brain function. It has been found to offer some protection to the brain when brain cells are deprived of their normal oxygen supply causing cells to die or be impaired. The aim of this study is to determine if EPO reduces secondary brain injury and helps patients make a better recovery after traumatic brain injury. The investigators also plan to

monitor the effect of EPO on the rate of deep vein thrombosis (DVT - blood clots in the

large veins in lower extremity) in patients with moderate or severe TBI in the intensive care unit (ICU). Study Hypothesis: In patients with moderate (GCS 9-12) or severe (3-8) TBI, EPO therapy improves long-term neurological function assessed 6 months after injury.

Eligibility

Minimum age: 15 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Are ≥ 15 to ≤ 65 years of age

- Are < 24 hours since primary traumatic injury

- Are expected to stay ≥ 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 written informed consent from legal surrogate

Exclusion Criteria:

- GCS = 3 and fixed dilated pupils

- History of DVT, PE or other thromboembolic event

- 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 post partum

- Uncontrolled hypertension (systolic blood pressure of >200 mm Hg or diastolic blood

pressure of >110 mm Hg)

- Acute myocardial infarct

- Expected to die imminently (< 24 hours)

- Inability to perform lower limb ultrasounds

- Known sensitivity to mammalian cell derived products

- Hypersensitivity to the active substance or to any of the additives

- Pure red cell aplasia (PRCA)

- 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

- Spinal cord injury

- Treatment with any investigational drug within 30 days before enrolment

- The treating physician believes it is not in the best interest of the patient to be

randomised to this trial

Locations and Contacts

Helsinki University Central Hospital, Helsinki 00029, Finland

Kuopio University Hospital, Kuopio 70211, Finland

Hôpital Michallon, Grenoble 38 043, France

Hôpital universitaire Caremeau, Nîmes 30029, France

Hôpital de Bicêtre, Paris 94275, France

Hôpital Lariboisière, Paris 75 475, France

CHU de Rouen, Rouen 76 031, France

Johannes Gutenberg-Universtität, Mainz D-55131, Germany

Beaumont Hospital, Dublin 9, Ireland

Dunedin Hospital, Dunedin, New Zealand

King Fahad National Guard Hospital, Riyadh 22490, Saudi Arabia

Canberra Hospital, Canberra, Australian Capital Territory 2605, Australia

Royal Prince Alfred Hospital, Camperdown, New South Wales 2050, Australia

St Vincent's Hospital Sydney, Darlinghurst, New South Wales 2010, Australia

Liverpool Hospital, Liverpool, New South Wales 2170, Australia

John Hunter Hospital, Newcastle, New South Wales 2305, Australia

Royal North Shore Hospital, St Leonards, New South Wales 2065, Australia

Westmead Hospital, Westmead, New South Wales 2145, Australia

Auckland City Hospital, Auckland, North Island 1023, New Zealand

Wellington Regional Hospital, Wellington, North Island 6021, New Zealand

Gold Coast University Hospital, Southport, Queensland 4215, Australia

The Townsville Hospital, Townsville, Queensland 4814, Australia

Royal Adelaide Hosptial, Adelaide, South Australia 5000, Australia

Christchurch Hospital, Christchurch, South Island 8011, New Zealand

Royal Hobart Hospital, Hobart, Tasmania 7000, Australia

The Alfred Hospital, Melbourne, Victoria 3181, Australia

The Royal Melbourne Hospital, Melbourne, Victoria 3050, Australia

Royal Perth Hospital, Perth, Western Australia, Australia

Additional Information

Starting date: May 2010
Last updated: July 29, 2015

Page last updated: August 23, 2015

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