Study Results
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Basic Information
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COMPLETED
PHASE3
606 participants
INTERVENTIONAL
2010-05-31
2015-05-31
Brief Summary
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Long Term Effects of Erythropoietin in Patients With Moderate to Severe Traumatic Brain Injury
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Safety Study of Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Epoetin Alfa
40,000 IU given as subcutaneous injection weekly up to 3 doses
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.
Sodium Chloride 0.9%
1 m/L given as subcutaneous injection weekly up to 3 doses
Interventions
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Epoetin Alfa
40,000 IU given as subcutaneous injection weekly up to 3 doses
Sodium Chloride 0.9%
1 m/L given as subcutaneous injection weekly up to 3 doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
65 Years
ALL
No
Sponsors
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National Health and Medical Research Council, Australia
OTHER
Australian and New Zealand Intensive Care Society Clinical Trials Group
NETWORK
Monash University
OTHER
Australian and New Zealand Intensive Care Research Centre
OTHER
Responsible Party
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Principal Investigators
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Alistair D Nichol, MD
Role: STUDY_CHAIR
Monash University
Locations
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Canberra Hospital
Canberra, Australian Capital Territory, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
Newcastle, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
The Townsville Hospital
Townsville, Queensland, Australia
Royal Adelaide Hosptial
Adelaide, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Helsinki University Central Hospital
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Hôpital Michallon
Grenoble, , France
Hôpital universitaire Caremeau
Nîmes, , France
Hôpital Lariboisière
Paris, , France
Hôpital de Bicêtre
Paris, , France
CHU de Rouen
Rouen, , France
Johannes Gutenberg-Universtität
Mainz, , Germany
Beaumont Hospital
Dublin, , Ireland
Auckland City Hospital
Auckland, North Island, New Zealand
Wellington Regional Hospital
Wellington, North Island, New Zealand
Christchurch Hospital
Christchurch, South Island, New Zealand
Dunedin Hospital
Dunedin, , New Zealand
King Fahad National Guard Hospital
Riyadh, , Saudi Arabia
Countries
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References
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Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.
Skrifvars MB, Bailey M, Moore E, Martensson J, French C, Presneill J, Nichol A, Little L, Duranteau J, Huet O, Haddad S, Arabi YM, McArthur C, Cooper DJ, Bendel S, Bellomo R; Erythropoietin in Traumatic Brain Injury (EPO-TBI) Investigators and the Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group. A Post Hoc Analysis of Osmotherapy Use in the Erythropoietin in Traumatic Brain Injury Study-Associations With Acute Kidney Injury and Mortality. Crit Care Med. 2021 Apr 1;49(4):e394-e403. doi: 10.1097/CCM.0000000000004853.
Skrifvars MB, Moore E, Martensson J, Bailey M, French C, Presneill J, Nichol A, Little L, Duranteau J, Huet O, Haddad S, Arabi Y, McArthur C, Cooper DJ, Bellomo R; EPO-TBI Investigators and the ANZICS Clinical Trials Group. Erythropoietin in traumatic brain injury associated acute kidney injury: A randomized controlled trial. Acta Anaesthesiol Scand. 2019 Feb;63(2):200-207. doi: 10.1111/aas.13244. Epub 2018 Aug 21.
Nichol A, French C, Little L, Haddad S, Presneill J, Arabi Y, Bailey M, Cooper DJ, Duranteau J, Huet O, Mak A, McArthur C, Pettila V, Skrifvars M, Vallance S, Varma D, Wills J, Bellomo R; EPO-TBI Investigators; ANZICS Clinical Trials Group. Erythropoietin in traumatic brain injury (EPO-TBI): a double-blind randomised controlled trial. Lancet. 2015 Dec 19;386(10012):2499-506. doi: 10.1016/S0140-6736(15)00386-4. Epub 2015 Oct 6.
Nichol A, French C, Little L, Presneill J, Cooper DJ, Haddad S, Duranteau J, Huet O, Skrifvars M, Arabi Y, Bellomo R; EPO-TBI Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial. Trials. 2015 Feb 8;16:39. doi: 10.1186/s13063-014-0528-6.
Presneill J, Little L, Nichol A, French C, Cooper DJ, Haddad S, Duranteau J, Huet O, Skrifvars M, Arabi Y, Bellomo R; EPO-TBI Investigators; ANZICS Clinical Trials Group. Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury. Trials. 2014 Dec 20;15:501. doi: 10.1186/1745-6215-15-501.
Moore EM, Bellomo R, Nichol AD. Erythropoietin as a novel brain and kidney protective agent. Anaesth Intensive Care. 2011 May;39(3):356-72. doi: 10.1177/0310057X1103900306.
Other Identifiers
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ANZIC-RC/RB002
Identifier Type: -
Identifier Source: org_study_id
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