Status:
COMPLETED
Erythropoietin in Traumatic Brain Injury (EPO-TBI)
Lead Sponsor:
Australian and New Zealand Intensive Care Research Centre
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Australian and New Zealand Intensive Care Society Clinical Trials Group
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
15-65 years
Phase:
PHASE3
Brief 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 m...
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. Previ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
606 Patients enrolled
Trial Details
Trial ID
NCT00987454
Start Date
May 1 2010
End Date
May 1 2015
Last Update
July 26 2016
Active Locations (28)
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1
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
2
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
3
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
4
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170