Trial reportThe Lancet. Neurology2011
Very early hypothermia induction in patients with severe brain injury (the National Acute Brain Injury Study: Hypothermia II): a randomised trial.
Trial report in The Lancet. Neurology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00178711 (National Acute Brain Injury Study), which is not on this map. Cited by 163 papers, 10 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.
National Acute Brain Injury Study: Hypothermia IIR
Who cites it
163 citing papers in PubMed, 10 syntheses or guidelines pooled it, 519 citations in OpenAlex.
- Comparative Effectiveness of Different Targeted Temperature Management Modalities for Adult Patients with Traumatic Brain Injury.Neurocritical care · 2026Pooled it
- Therapeutic Hypothermia Compared with Normothermia in Adults with Traumatic Brain Injury; Functional Outcome, Mortality, and Adverse Effects: A Systematic Review and Meta-Analysis.Neurocritical care · 2024Pooled it
- A meta-analysis of the effects of therapeutic hypothermia in adult patients with traumatic brain injury.Critical care (London, England) · 2019Pooled it
- Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys.JAMA network open · 2019Pooled it
- The Implementation of Targeted Temperature Management: An Evidence-Based Guideline from the Neurocritical Care Society.Neurocritical care · 2017Pooled it
- Hypothermia for traumatic brain injury.The Cochrane database of systematic reviews · 2017Pooled it
- Therapeutic Hypothermia and the Risk of Hemorrhage: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Medicine · 2015Pooled it
- A Systematic Review of the Effects of Body Temperature on Outcome After Adult Traumatic Brain Injury.The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses · 2015Pooled it
- Clinical evidence of inflammation driving secondary brain injury: a systematic review.The journal of trauma and acute care surgery · 2015Pooled it
- Management of bleeding and coagulopathy following major trauma: an updated European guideline.Critical care (London, England) · 2013Pooled it
- Hypothermia for Patients Requiring Evacuation of Subdural Hematoma: A Multicenter Randomized Clinical Trial.Neurocritical care · 2022Trial
- Disability Rating Scale in the First Few Weeks After a Severe Traumatic Brain Injury as a Predictor of 6-Month Functional Outcome.Neurosurgery · 2021Trial
- Esophageal Temperature Management in Patients Suffering from Traumatic Brain Injury.Therapeutic hypothermia and temperature management · 2019Trial
- Mild decrease in heart rate during early phase of targeted temperature management following tachycardia on admission is associated with unfavorable neurological outcomes after severe traumatic brain injury: a post hoc analysis of a multicenter randomized controlled trial.Critical care (London, England) · 2018Trial
- Trial
- Slow rewarming improved the neurological outcomes of prolonged mild therapeutic hypothermia in patients with severe traumatic brain injury and an evacuated hematoma.Scientific reports · 2018Trial
- Mortality Risk Stratification After Traumatic Brain Injury and Hazard of Death With Titrated Hypothermia in the Eurotherm3235Trial.Critical care medicine · 2017Trial
- Fever Control Management Is Preferable to Mild Therapeutic Hypothermia in Traumatic Brain Injury Patients with Abbreviated Injury Scale 3-4: A Multi-Center, Randomized Controlled Trial.Journal of neurotrauma · 2016Trial
- Therapeutic Hypothermia Reduces Intracranial Pressure and Partial Brain Oxygen Tension in Patients with Severe Traumatic Brain Injury: Preliminary Data from the Eurotherm3235 Trial.Therapeutic hypothermia and temperature management · 2015Trial
- Comparative study of outcome measures and analysis methods for traumatic brain injury trials.Journal of neurotrauma · 2015Trial
103 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
20 authors at 8 institutions in 2 countries.
Funding
Abstract
backgroundThe inconsistent effect of hypothermia treatment on severe brain injury in previous trials might be because hypothermia was induced too late after injury. We aimed to assess whether very early induction of hypothermia improves outcome in patients with severe brain injury.
methodsThe National Acute Brain Injury Study: Hypothermia II (NABIS: H II) was a randomised, multicentre clinical trial of patients with severe brain injury who were enrolled within 2·5 h of injury at six sites in the USA and Canada. Patients with non-penetrating brain injury who were 16-45 years old and were not responsive to instructions were randomly assigned (1:1) by a random number generator to hypothermia or normothermia. Patients randomly assigned to hypothermia were cooled to 35°C until their trauma assessment was completed. Patients who had none of a second set of exclusion criteria were either cooled to 33°C for 48 h and then gradually rewarmed or treated at normothermia, depending upon their initial treatment assignment. Investigators who assessed the outcome measures were masked to treatment allocation. The primary outcome was the Glasgow outcome scale score at 6 months. Analysis was by modified intention to treat. This trial is registered with ClinicalTrials.gov, NCT00178711.
findingsEnrolment occurred from December, 2005, to June, 2009, when the trial was terminated for futility. Follow-up was from June, 2006, to December, 2009. 232 patients were initially randomised a mean of 1·6 h (SD 0·5) after injury: 119 to hypothermia and 113 to normothermia. 97 patients (52 in the hypothermia group and 45 in the normothermia group) did not meet any of the second set of exclusion criteria. The mean time to 35°C for the 52 patients in the hypothermia group was 2·6 h (SD 1·2) and to 33°C was 4·4 h (1·5). Outcome was poor (severe disability, vegetative state, or death) in 31 of 52 patients in the hypothermia group and 25 of 56 in the normothermia group (relative risk [RR] 1·08, 95% CI 0·76-1·53; p=0·67). 12 patients in the hypothermia group died compared with eight in the normothermia group (RR 1·30, 95% CI 0·58-2·52; p=0·52).
interpretationThis trial did not confirm the utility of hypothermia as a primary neuroprotective strategy in patients with severe traumatic brain injury.
Indexed as
Identifiers
What OpenQuestion holds
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.