Erythropoietin in Traumatic Brain Injury (EPO-TBI)

Last updated: July 24, 2016
Sponsor: Australian and New Zealand Intensive Care Research Centre
Overall Status: Completed

Phase

3

Condition

Memory Loss

Traumatic Brain Injury

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00987454
ANZIC-RC/RB002
  • Ages 15-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 bloodpressure 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 mayinterfere 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 berandomised to this trial

Study Design

Total Participants: 606
Study Start date:
May 01, 2010
Estimated Completion Date:
May 31, 2015

Study 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.

Connect with a study center

  • Canberra Hospital

    Canberra, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • John Hunter Hospital

    Newcastle, New South Wales 2305
    Australia

    Site Not Available

  • Nepean Hospital

    Penrith, New South Wales 2750
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Gold Coast University Hospital

    Southport, Queensland 4215
    Australia

    Site Not Available

  • The Townsville Hospital

    Townsville, Queensland 4814
    Australia

    Site Not Available

  • Royal Adelaide Hosptial

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Royal Hobart Hospital

    Hobart, Tasmania 7000
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3181
    Australia

    Site Not Available

  • The Royal Melbourne Hospital

    Melbourne, Victoria 3050
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia
    Australia

    Site Not Available

  • Helsinki University Central Hospital

    Helsinki, 00029
    Finland

    Site Not Available

  • Kuopio University Hospital

    Kuopio, 70211
    Finland

    Site Not Available

  • Tampere University Hospital

    Tampere, 33521
    Finland

    Site Not Available

  • Hôpital Michallon

    Grenoble, 38 043
    France

    Site Not Available

  • Hôpital universitaire Caremeau

    Nîmes, 30029
    France

    Site Not Available

  • Hôpital Lariboisière

    Paris, 75 475
    France

    Site Not Available

  • Hôpital de Bicêtre

    Paris, 94275
    France

    Site Not Available

  • CHU de Rouen

    Rouen, 76 031
    France

    Site Not Available

  • Hôpital Purpan

    Toulouse, 31059
    France

    Site Not Available

  • Charité Universitätsmedizin

    Berlin, D-11179
    Germany

    Site Not Available

  • Johannes Gutenberg-Universtität

    Mainz, D-55131
    Germany

    Site Not Available

  • Beaumont Hospital

    Dublin, 9
    Ireland

    Site Not Available

  • Auckland City Hospital

    Auckland, North Island 1023
    New Zealand

    Site Not Available

  • Wellington Regional Hospital

    Wellington, North Island 6021
    New Zealand

    Site Not Available

  • Christchurch Hospital

    Christchurch, South Island 8011
    New Zealand

    Site Not Available

  • Dunedin Hospital

    Dunedin,
    New Zealand

    Site Not Available

  • King Fahad National Guard Hospital

    Riyadh, 22490
    Saudi Arabia

    Site Not Available

  • Tan Tock Seng Hospital and the National Neuroscience Insititute

    Singapore, 308433
    Singapore

    Site Not Available

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