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Trial from ANZCTR

A randomised, placebo-controlled trial evaluating the effect of erythropoietin on neurological function in intensive care unit (ICU) patients with traumatic brain injury

  • Recruitment status at the time of last update
    Completed
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 28/8/2015)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12609000827235

Date registered

22 September 2009

Health condition

Moderate traumatic brain injury, Severe traumatic brain injury

Recruitment countries

Australia

Recruitment status

Completed

Anticipated date of first participant enrolment

01 February 2010

Ethics application status

Approved

Brief summary

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).

Eligibility

Key inclusion criteria

Admitted to ICU with non-penetrating traumatic brain injury
15 to 65 years of age
Less than 24 hours since primary traumatic injury
Expected to stay greater than or equal to 48 hours
Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution
Written informed consent from legal surrogate

Minimum age

15 Years

Maximum age

65 Years

Gender

Both males and females

Key exclusion criteria

Glasgow Coma Score (GCS) is 3 and pupils are fixed and dilated; 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 greater than 200 mm Hg or diastolic blood pressure of greater than 110 mm Hg); Acute myocardial infarct; Expected to die imminently (within 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.

Contact details and further information

Primary Sponsor

Type: University
Name: Australian and New Zealand Intensive Care Research Centre
Address: Department of Epidemiology and Preventive Medicine Monash University, Level 6 The Alfred Centre 99 Commercial Road Melbourne Vic 3004
Country: Australia

Contact person for information and recruitment

Ms Lorraine Little
Department of Epidemiology and Preventive Medicine, Monash University Level 6, The Alfred Centre, 99 Commercial Road Melbourne Vic 3004
Australia
+61 3 9903 0513
lorraine.little@monash.edu