Trial reportTrials2015
Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00987454 (A Randomised, Placebo-controlled Trial of Erythropoietin in ICU Patients With Traumatic Brain Injury), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomised, Placebo-controlled Trial of Erythropoietin in ICU Patients With Traumatic Brain Injury
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Erythropoiesis-stimulating agents for preventing acute kidney injury.The Cochrane database of systematic reviews · 2024Pooled it
- Harms of off-label erythropoiesis-stimulating agents for critically ill people.The Cochrane database of systematic reviews · 2017Pooled it
- Venous thromboembolic events in critically ill traumatic brain injury patients.Intensive care medicine · 2017Trial
- Dual-targeting AAV9P1-mediated neuronal reprogramming in a mouse model of traumatic brain injury.Neural regeneration research · 2024Article
- The effect of recombinant erythropoietin on long-term outcome after moderate-to-severe traumatic brain injury.Intensive care medicine · 2023Article
- Is There a Role for Hematopoietic Growth Factors During Sepsis?Frontiers in immunology · 2018Review
- Cerebrospinal fluid neuron specific enolase, interleukin-1β and erythropoietin concentrations in children after seizures.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2017Article
- Pathophysiology Associated with Traumatic Brain Injury: Current Treatments and Potential Novel Therapeutics.Cellular and molecular neurobiology · 2017Review
- Erythropoietin either Prevents or Exacerbates Retinal Damage from Eye Trauma Depending on Treatment Timing.Optometry and vision science : official publication of the American Academy of Optometry · 2017Article
- Technique of ICP Monitored Stepwise Intracranial Decompression Effectively Reduces Postoperative Complications of Severe Bifrontal Contusion.Frontiers in neurology · 2016Article
- Is erythropoietin a worthy candidate for traumatic brain injury or are we heading the wrong way?F1000Research · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 10 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTraumatic 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/
designThe 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 registrationAustralian 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).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.