Therapeutic hypothermia to reduce intracranial pressure after traumatic brain injury: the Eurotherm3235 RCT
Andrews PJD, Sinclair HL, Rodríguez A, Harris B, Rhodes J, Watson H, Murray G
Record ID 32018000277
English
Authors' objectives:
The Eurotherm3235 Trial was a pragmatic trial examining the effectiveness of hypothermia (32–35 °C) to reduce raised intracranial pressure (ICP) following severe TBI and reduce morbidity and mortality 6 months after TBI.
Authors' results and conclusions:
Results: We enrolled 387 patients from 47 centres in 18 countries. The trial was closed to recruitment following concerns raised by the Data and Safety Monitoring Committee in October 2014. On an intention-to-treat basis, 195 participants were randomised to hypothermia treatment and 192 to standard care. Regarding participant outcome, there was a higher mortality rate and poorer functional recovery at 6 months in the hypothermia group. The adjusted common odds ratio (OR) for the primary statistical analysis of the GOSE was 1.54 [95% confidence interval (CI) 1.03 to 2.31]; when the GOSE was dichotomised the OR was 1.74 (95% CI 1.09 to 2.77). Both results favoured standard care alone. In this pragmatic study, we did not collect data on adverse events. Data on serious adverse events (SAEs) were collected but were subject to reporting bias, with most SAEs being reported in the hypothermia group.
Conclusions: In participants following TBI and with an ICP of > 20 mmHg, titrated therapeutic hypothermia successfully reduced ICP but led to a higher mortality rate and worse functional outcome.
Authors' methods:
Design: An international, multicentre, randomised controlled trial.
Details
Project Status:
Completed
Year Published:
2018
URL for published report:
https://www.journalslibrary.nihr.ac.uk/hta/hta22450
English language abstract:
An English language summary is available
Publication Type:
Full HTA
Country:
England, United Kingdom
MeSH Terms
- Adolescent
- Adult
- Age Factors
- Aged
- Brain Injuries, Traumatic
- Child
- Child, Preschool
- Cost-Benefit Analysis
- Female
- Glasgow Outcome Scale
- Hypothermia, Induced
- Intracranial Pressure
- Length of Stay
- Male
- Middle Aged
- Pneumonia, Ventilator-Associated
- Quality of Life
- Quality-Adjusted Life Years
- State Medicine
- Technology Assessment, Biomedical
- Time-to-Treatment
- Young Adult
Contact
Organisation Name:
NIHR Health Technology Assessment programme
Contact Address:
NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name:
journals.library@nihr.ac.uk
Contact Email:
journals.library@nihr.ac.uk
Copyright:
2009 Queen's Printer and Controller of HMSO
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.