Erythropoietin in Traumatic Brain Injury (EPO-TBI)
This study is currently recruiting participants.
Verified February 2013 by Australian and New Zealand Intensive Care Research Centre
Sponsor:
Australian and New Zealand Intensive Care Research Centre
Collaborators:
National Health and Medical Research Council, Australia
Transport Accident Commission
Australian and New Zealand Intensive Care Society Clinical Trials Group
Monash University
Information provided by (Responsible Party):
Siouxzy Morrison, Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier:
NCT00987454
First received: September 29, 2009
Last updated: February 11, 2013
Last verified: February 2013
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Purpose
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).
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Traumatic Brain Injury |
Drug: Epoetin Alfa Drug: Placebo, Sodium Chloride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomised, Placebo-controlled Trial of Erythropoietin in ICU Patients With Traumatic Brain Injury |
Resource links provided by NLM:
Further study details as provided by Australian and New Zealand Intensive Care Research Centre:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Proportion of surviving patients with unfavourable neurological outcome (GOSE 2-4) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Quality of life assessment (SF-12 and EQ-5D) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Mortality at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Rate of proximal deep venous thrombosis detected during screening by compression Doppler ultrasound [ Time Frame: up to ICU discharge ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Cost effectiveness analysis at 6 months (based on EQ-5D) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 606 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Erythropoietin |
Drug: Epoetin Alfa
40,000 IU given as subcutaneous injection weekly up to 3 doses
|
| Placebo Comparator: Placebo |
Drug: Placebo, Sodium Chloride
1 ml given as a subcutaneous injection weekly up to 3 doses
|
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987454
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Contacts
| Contact: Rinaldo Bellomo, MD | +61 3 9496 5992 | Rinaldo.BELLOMO@austin.org.au |
| Contact: Lorraine M Little, RN BHSc(Nursing) MBioethics | +61 3 9903 0513 | lorraine.little@monash.edu |
Hide Study LocationsLocations
| Australia, Australian Capital Territory | |
| Canberra Hospital | Recruiting |
| Canberra, Australian Capital Territory, Australia, 2605 | |
| Contact: Imogen Mitchell, MD +61 2 6244 2222 imogen.mitchell@act.gov.au | |
| Principal Investigator: Imogen Mitchell, MD | |
| Australia, New South Wales | |
| Royal Prince Alfred Hospital | Recruiting |
| Camperdown, New South Wales, Australia, 2050 | |
| Contact: David Gattas, MD +61 2 9515 6111 dgattas@gmail.com | |
| Principal Investigator: David Gattas, MD | |
| St Vincent's Hospital Sydney | Recruiting |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Contact: Priya Nair, MD +61 2 8382 1111 pnair@stvincents.com.au | |
| Principal Investigator: Priya Nair, MD | |
| Liverpool Hospital | Recruiting |
| Liverpool, New South Wales, Australia, 2170 | |
| Contact: Victor Tam, MD +61 2 9828 3000 victor.tam@sswahs.nsw.gov.au | |
| Principal Investigator: Victor Tam, MD | |
| John Hunter Hospital | Recruiting |
| Newcastle, New South Wales, Australia, 2305 | |
| Contact: Peter Harrigan, MD +61 2 49213000 peter.harrigan@hnehealth.nsw.gov.au | |
| Principal Investigator: Peter Harrigan, MD | |
| Nepean Hospital | Not yet recruiting |
| Penrith, New South Wales, Australia, 2750 | |
| Contact: Louise Cole, MD +61 2 4734 2000 colel@med.usyd.edu.au | |
| Principal Investigator: Louise Cole, MD | |
| Royal North Shore Hospital | Recruiting |
| St Leonards, New South Wales, Australia, 2065 | |
| Contact: Simon Finfer, MD +61 2 9926 8656 sfinfer@george.org.au | |
| Principal Investigator: Simon Finfer, MD | |
| Westmead Hospital | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Contact: Vineet Nayyar, MD +61 2 9845 5555 Vineet_Nayyar@wsahs.nsw.gov.au | |
| Principal Investigator: Vineet Nayyar, MD | |
| Australia, Queensland | |
| Gold Coast Hospital | Recruiting |
| Southport, Queensland, Australia, 4215 | |
| Contact: Brent Richards, MD +61 7 5519 8211 BRENT_RICHARDS@HEALTH.QLD.GOV.AU | |
| Principal Investigator: Brent Richards, MD | |
| The Townsville Hospital | Recruiting |
| Townsville, Queensland, Australia, 4814 | |
| Contact: Geoffrey Gordon, MD +61 7 4796 1111 geoffrey_gordon@health.qld.gov.au | |
| Principal Investigator: Geoffrey Gordon, MD | |
| Australia, South Australia | |
| Royal Adelaide Hosptial | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Contact: Richard Strickland, MD +61 8 8222 4000 rich.stricko@gmail.com | |
| Principal Investigator: Richard Strickland, MD | |
| Australia, Tasmania | |
| Royal Hobart Hospital | Recruiting |
| Hobart, Tasmania, Australia, 7000 | |
| Contact: David Cooper, MD +61 3 6222 8308 david.cooper@dhhs.tas.gov.au | |
| Principal Investigator: David Cooper, MD | |
| Australia, Victoria | |
| The Alfred Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3181 | |
| Contact: David J Cooper, MD +61 3 9076 2000 j.cooper@alfred.org.au | |
| Principal Investigator: David J Cooper, MD | |
| The Royal Melbourne Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3050 | |
| Contact: Nerina Harley, MD +61 3 9342 7000 ext 27441 nerina.harley@mh.org.au | |
| Principal Investigator: Nerina Harley, MD | |
| Australia, Western Australia | |
| Royal Perth Hospital | Recruiting |
| Perth, Western Australia, Australia | |
| Contact: Geoffrey Dobb, MD +61 8 9224 2244 geoffrey.dobb@health.wa.gov.au | |
| Principal Investigator: Geoffrey Dobb, MD | |
| Finland | |
| Helsinki University Central Hospital | Recruiting |
| Helsinki, Finland, 00029 | |
| Contact: Ville Pettila, MD Ville.Pettila@hus.fi | |
| Contact: Markus Skrivfars, MD +358 9 47187383 ext 383 Markus.Skrifvars@hus.fi | |
| Principal Investigator: Ville Pettila, MD | |
| Principal Investigator: Markus Skrifvars, MD | |
| Kuopio University Hospital | Recruiting |
| Kuopio, Finland, 70211 | |
| Contact: Stepani Bendel, MD stepani.bendel@kuh.fi | |
| Principal Investigator: Stepani Bendel, MD | |
| Tampere University Hospital | Not yet recruiting |
| Tampere, Finland, 33521 | |
| Contact: Anne Kuitunen, MD Anne.Kuitunen@pshp.fi | |
| Principal Investigator: Anne Kuitunen, MD | |
| France | |
| Hôpital Michallon | Recruiting |
| Grenoble, France, 38 043 | |
| Contact: Jean François Payen, MD Jean-Francois.Payen@ujf-grenoble.fr | |
| Principal Investigator: Jean François Payen, MD | |
| Hôpital universitaire Caremeau | Not yet recruiting |
| Nîmes, France, 30029 | |
| Contact: Jean Yves Lefrant, MD jean-yves.lefrant@wanadoo.fr | |
| Principal Investigator: Jean Yves Lefrant, MD | |
| Hôpital Lariboisière | Recruiting |
| Paris, France, 75 475 | |
| Contact: Didier Payen, MD didier.payen@lrb.aphp.fr | |
| Principal Investigator: Didier Payen, MD | |
| Hôpital de Bicêtre | Recruiting |
| Paris, France, 94275 | |
| Contact: Jacques Duranteau, MD jacques.duranteau@bct.aphp.fr | |
| Contact: Anatole Harrois, MD anatole.harrois@bct.aphp.fr | |
| Principal Investigator: Jacques Duranteau, MD | |
| CHU de Rouen | Not yet recruiting |
| Rouen, France, 76 031 | |
| Contact: Benoit Veber, MD | |
| Principal Investigator: Benoit Veber, MD | |
| Hôpital Rangueil | Not yet recruiting |
| Toulouse, France, 31059 | |
| Contact: Thomas Geeraerts, MD thgeeraerts@hotmail.com | |
| Principal Investigator: Thomas Geeraerts, MD | |
| Germany | |
| Charité Universitätsmedizin | Not yet recruiting |
| Berlin, Germany, D-11179 | |
| Contact: Stefan Wolf, MD stefan.wolf@charite.de | |
| Principal Investigator: Stefan Wolf, MD | |
| Johannes Gutenberg-Universtität | Not yet recruiting |
| Mainz, Germany, D-55131 | |
| Contact: Thomas Kerz, MD kerz@uni-mainz.de | |
| Principal Investigator: Thomas Kerz, MD | |
| Ireland | |
| Beaumont Hospital | Not yet recruiting |
| Dublin, Ireland, 9 | |
| Contact: Criona Walshe, MD crionawalshe@gmail.com | |
| Principal Investigator: Criona Walshe, MD | |
| New Zealand | |
| Auckland City Hospital | Recruiting |
| Auckland, North Island, New Zealand, 1023 | |
| Contact: Colin McArthur, MD + 64 9 379 7440 colinm@adhb.govt.nz | |
| Principal Investigator: Colin McArthur, MD | |
| Wellington Regional Hospital | Recruiting |
| Wellington, North Island, New Zealand, 6021 | |
| Contact: Richard Dinsdale, MD + 64 4 385 5999 dick.dinsdale@ccdhb.org.nz | |
| Principal Investigator: Richard Dinsdale, MD | |
| Christchurch Hospital | Recruiting |
| Christchurch, South Island, New Zealand, 8011 | |
| Contact: Seton Henderson, MD + 64 3 3640640 seton.henderson@cdhb.govt.nz | |
| Principal Investigator: Seton Henderson, MD | |
| Saudi Arabia | |
| King Fahad National Guard Hospital | Recruiting |
| Riyadh, Saudi Arabia, 22490 | |
| Contact: Samir Haddad, MD 996612520088 ext 18923 haddadS@NGHA.MED.SA | |
| Principal Investigator: Samir Haddad, MD | |
| Singapore | |
| Tan Tock Seng Hospital and the National Neuroscience Insititute | Not yet recruiting |
| Singapore, Singapore, 308433 | |
| Contact: Hui Ling Tan, MD hui_ling_tan@ttsh.com.sg | |
| Principal Investigator: Hui Ling Tan, MD | |
| Principal Investigator: Boon Chuan Pang, MD | |
Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
National Health and Medical Research Council, Australia
Transport Accident Commission
Australian and New Zealand Intensive Care Society Clinical Trials Group
Monash University
Investigators
| Study Chair: | Alistair D Nichol, MD | Monash University |
More Information
No publications provided by Australian and New Zealand Intensive Care Research Centre
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Siouxzy Morrison, Executive Officer, Australian and New Zealand Intensive Care Research Centre |
| ClinicalTrials.gov Identifier: | NCT00987454 History of Changes |
| Other Study ID Numbers: | ANZIC-RC/RB002 |
| Study First Received: | September 29, 2009 |
| Last Updated: | February 11, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |
Wounds and Injuries Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013