Background: Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.
Methods/design: The erythropoietin in traumatic brain injury trial is a stratified prospective, multi-centre, randomised, blinded, parallel-group, placebo-controlled phase III trial. It aims to determine whether the administration of erythropoietin compared to placebo improves neurological outcome in patients with moderate or severe traumatic brain injury at six months after injury. The trial is designed to recruit 606 patients between 15 and 65 years of age with severe (Glasgow Coma Score: 3 to 8) or moderate (Glasgow Coma Score: 9 to 12) traumatic brain injury in Australia, New Zealand, Kingdom of Saudi Arabia, France, Finland, Germany and Ireland. Trial patients will receive either subcutaneous erythropoietin or placebo within 24 hours of injury, and weekly thereafter for up to three doses during the intensive care unit admission. The primary outcome will be the combined proportion of unfavourable neurological outcomes at six months: severe disability or death. Secondary outcomes will include the rate of proximal deep venous thrombosis detected by compression Doppler ultrasound, six-month mortality, the proportion of patients with composite vascular events (deep venous thrombosis, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at six months and quality of life with health economic evaluations.
Discussion: When completed, the trial aims to provide evidence on the efficacy and safety of erythropoietin in traumatic brain injury patients, and to provide clear guidance for clinicians in their management of this devastating condition.
Trial Registration: Australian New Zealand Clinical Trials registry: ACTRN12609000827235 (registered on 22 September 2009). Clinicaltrials.gov: NCT00987454 (registered on 29 September 2009). European Drug Regulatory Authorities Clinical Trials: 2011-005235-22 (registered on 18 January 2012).
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326467 | PMC |
| http://dx.doi.org/10.1186/s13063-014-0528-6 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Molecular biomarkers associated with TBI outcome in individuals of Black racial identity or African ancestry: a narrative review.
World Neurosurg
December 2024
College of Medicine, SUNY Downstate Health Sciences University, Brooklyn, New York, USA; Global Neurosurgery Laboratory, SUNY Downstate Health Sciences University, Brooklyn, New York, USA; Department of Neurology, One Brooklyn Health/Brookdale University Hospital and Medical Center, Brooklyn, New York, USA; Department of Neurology; SUNY Downstate Health Sciences University, Brooklyn, New York, USA; Institute for Genomics in Health, SUNY Downstate Health Sciences University, Brooklyn, New York, USA; Division of Neurosurgery, Department of Surgery, SUNY Downstate Health Sciences University, Brooklyn, New York, USA; Department of Community Health Sciences, School of Public Health, SUNY Downstate Health Sciences University; Department of Surgery, One Brooklyn Health/Brookdale University Hospital and Medical Center, Brooklyn, New York, USA. Electronic address:
Traumatic brain injury (TBI) is a leading cause of death and disability worldwide and a major global health concern. In the United States (US), individuals of Black or African American racial identity experience disproportionately higher rates of TBI and suffer from worse post-injury outcomes. Contemporary research agendas have largely overlooked or excluded Black populations, resulting in the continued marginalization of Black patient populations in TBI studies, thereby limiting the generalizability of ongoing research to patients in the US and around the world.
View Article and Find Full Text PDFThe HR antagonist, JNJ-7777120 treatments ameliorate mild traumatic brain injury by reducing oxidative damage, inflammatory and apoptotic responses through blockage of the ERK1/2/NF-κB pathway in a rat model.
Exp Neurol
December 2024
Department of Molecular Biology and Genetics, Faculty of Science, Istanbul University, Istanbul, Turkiye. Electronic address:
Growing evidence reveals that microglia activation and neuroinflammatory responses trigger cell loss in the brain. Histamine is a critical neurotransmitter and promotes inflammatory responses; thus, the histaminergic system is a potential target for treating neurodegenerative processes. JNJ-7777120, a histamine H4 receptor (HR) antagonist, has been shown to alleviate inflammation, brain damage, and behavioral deficits effectively, but there is no report on its role in brain trauma.
View Article and Find Full Text PDFThe Historical and Clinical Foundations of the Modern Neuroscience Intensive Care Unit.
World Neurosurg
December 2024
Clinical and Translational Neuroscience Unit, Department of Neurology and Feil Brain and Mind Research Institute, Weill Cornell Medicine, New York, New York, USA. Electronic address:
The subspecialty of neurocritical care has grown significantly over the past 40 years along with advancements in the medical and surgical management of neurological emergencies. The modern neuroscience intensive care unit (neuro-ICU) is grounded in close collaboration between neurointensivists and neurosurgeons in the management of patients with such conditions as ischemic stroke, aneurysmal subarachnoid hemorrhage, intracerebral hemorrhage, subdural hematomas, and traumatic brain injury. Neuro-ICUs are also capable of specialized monitoring such as serial neurological examinations by trained neuro-ICU nurses; invasive monitoring of intracranial pressure, cerebral oxygenation, and cerebral hemodynamics; cerebral microdialysis; and noninvasive monitoring, including the use of pupillometry, ultrasound monitoring of optic nerve sheath diameters, transcranial Doppler ultrasonography, near-infrared spectroscopy, and continuous electroencephalography.
View Article and Find Full Text PDFCurrent Challenges in Neurocritical Care: A Narrative Review.
World Neurosurg
December 2024
Department of Neurology, NewYork-Presbyterian Weill Cornell Medicine, New York, New York, USA. Electronic address:
Neurocritical care as a field aims to treat patients who are neurologically critically ill due to a variety of pathologies. As a recently developed subspecialty, the field faces challenges, several of which are outlined in this review. The authors discuss aneurysmal subarachnoid hemorrhage, status epilepticus, and traumatic brain injury as specific disease processes with opportunities for growth in diagnosis, management, and treatment, as well as disorders of consciousness that can arise as a result of many neurological injuries.
View Article and Find Full Text PDFBehavioral Outcomes After Inpatient Rehabilitation in Pediatric and Adolescent Trauma Patients.
J Pediatr Surg
December 2024
Children's Hospital New Orleans, Department of Surgery, New Orleans LA 70118, USA; Louisiana State University Health Sciences Center, Department of Surgery, Division of Pediatric Surgery, New Orleans LA 70112, USA. Electronic address:
Introduction: Traumatic injury is the leading cause of pediatric mortality and morbidity in the United States. While behavioral impairments of children after traumatic brain injury (TBI) have been described, outcomes following traumatic spinal cord injury (SCI) and multi-trauma (MT) are less known. We aimed to address the prevalence of behavioral and neuropsychiatric disorders in pediatric and adolescent trauma patients.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!