Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00987454 : Erythropoietin in Traumatic Brain Injury (EPO-TBI)
PhasePhase 3
AgesMin: 15 Years Max: 65 Years
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00987454      |      Link to official Clinicaltrials.gov listing
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