Trial reportTrials2013
Study of therapeutic hypothermia (32 to 35°C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial): outcome of the pilot phase of the trial.
Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02420639 (Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device in 15 Patients Suffering From Traumatic Brain Injury and Treated With Targeted Temperature Management), which is not on this map. Cited by 9 papers.
What it found
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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.
Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device in 15 Patients Suffering From Traumatic Brain Injury and Treated With Targeted Temperature Management
Who cites it
9 citing papers in PubMed.
- Mortality Risk Stratification After Traumatic Brain Injury and Hazard of Death With Titrated Hypothermia in the Eurotherm3235Trial.Critical care medicine · 2017Trial
- The impact of mild induced hypothermia on the rate of transfusion and the mortality in severely injured patients: a retrospective multi-centre study.European journal of medical research · 2016Trial
- Review
- Targeted temperature management in traumatic brain injury.Journal of intensive care · 2016Review
- Temperature modulation with an esophageal heat transfer device - a pediatric swine model study.BMC anesthesiology · 2015Article
- The use of targeted temperature management for elevated intracranial pressure.Current neurology and neuroscience reports · 2014Review
- Therapeutic Hypothermia in Children and Adults with Severe Traumatic Brain Injury.Therapeutic hypothermia and temperature management · 2014Review
- Traumatic Brain Injury pathophysiology and treatments: early, intermediate, and late phases post-injury.International journal of molecular sciences · 2013Review
- A pilot, single-arm feasibility study of a multidimensional behavioral intervention for cognitive fatigability in multiple sclerosis: Mental Energy Boost program.Frontiers in neurologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundClinical trials in traumatic brain injury (TBI) are challenging. Previous trials of complex interventions were conducted in high-income countries, reported long lead times for site setup and low screened-to-recruitment rates.In this report we evaluate the internal pilot phase of an international, multicentre TBI trial of a complex intervention to assess: design and implementation of an online case report form; feasibility of recruitment (sites and patients); feasibility and effectiveness of delivery of the protocol.
methodsAll aspects of the pilot phase of the trial were conducted as for the main trial. The pilot phase had oversight by independent Steering and Data Monitoring committees.
resultsForty sites across 12 countries gained ethical approval. Thirty seven of 40 sites were initiated for recruitment. Of these, 29 had screened patients and 21 randomized at least one patient. Lead times to ethics approval (6.8 weeks), hospital approval (18 weeks), interest to set up (61 weeks), set up to screening (11 weeks), and set up to randomization (31.6 weeks) are comparable with other international trials. Sixteen per cent of screened patients were eligible. We found 88% compliance rate with trial protocol.
conclusionThe pilot data demonstrated good feasibility for this large international multicentre randomized controlled trial of hypothermia to control intracranial pressure. The sample size was reduced to 600 patients because of homogeneity of the patient group and we showed an optimized cooling intervention could be delivered.
trial registrationCurrent Controlled Trials: ISRCTN34555414.
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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.