Erythropoietin in Traumatic Brain Injury (EPO-TBI) (EPO-TBI)
|Traumatic Brain Injury||Drug: Epoetin Alfa Drug: Sodium Chloride 0.9%||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomised, Placebo-controlled Trial of Erythropoietin in ICU Patients With Traumatic Brain Injury|
- Combined proportion of unfavourable neurological outcomes at 6 months: severe disability (defined as GOSE scores 2-4) or death (GOSE score 1). [ Time Frame: 6 months ]
- 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 [ Time Frame: 6 months ]
- Proportion of surviving patients with unfavourable neurological outcome (GOSE 2-4) at 6 months [ Time Frame: 6 months ]
- Quality of life assessment (SF-12 and EQ-5D) at 6 months [ Time Frame: 6 months ]
- Mortality at 6 months [ Time Frame: 6 months ]
- Rate of proximal deep venous thrombosis detected during screening by compression Doppler ultrasound [ Time Frame: 21 days ]
- Proportion of patients with composite thrombotic vascular events (DVT, pulmonary embolus, myocardial infarction, cardiac arrest and cerebrovascular events) at 6 months [ Time Frame: 6 months ]
- Cost effectiveness analysis at 6 months (based on EQ-5D) [ Time Frame: 6 months ]
|Study Start Date:||May 2010|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Erythropoietin
Epoetin alfa 40,000 international units will be given by subcutaneous injection to eligible patients, allocated to the treatment arm, on Study Days 1; 8 and15 during the intensive care unit stay.
Drug: Epoetin Alfa
40,000 IU given as subcutaneous injection weekly up to 3 doses
Other Name: Eprex
Placebo Comparator: Placebo
Sodium Chloride 0.9% in m/L will be given by subcutaneous injection to eligible patients, allocated to the placebo arm, on Study Days 1; 8 and15 during the intensive care unit stay.
Drug: Sodium Chloride 0.9%
1 m/L given as subcutaneous injection weekly up to 3 doses
Other Name: Normal Saline
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).
In patients with moderate (GCS 9-12) or severe (3-8) TBI, EPO therapy improves long-term neurological function assessed 6 months after injury.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987454
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|Study Chair:||Alistair D Nichol, MD||Monash University|