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BACKGROUND: Traumatic brain injury is a major cause of death and severe disability worldwide with 1,000,000 hospital admissions per annum throughout the European Union.Therapeutic hypothermia to reduce intracranial hypertension may improve patient outcome but key issues are length of hypothermia treatment and speed of re-warming. A recent meta-analysis showed improved outcome when hypothermia was continued for between 48 hours and 5 days and patients were re-warmed slowly (1 °C/4 hours). Previous experience with cooling also appears to be important if complications, which may outweigh the benefits of hypothermia, are to be avoided. METHODS/DESIGN: This is a pragmatic, multi-centre randomised controlled trial examining the effects of hypothermia 32-35 °C, titrated to reduce intracranial pressure 20 mmHg in accordance with the Brain Trauma Foundation Guidelines, 2007. DISCUSSION: The Eurotherm3235Trial is the most important clinical trial in critical care ever conceived by European intensive care medicine, because it was launched and funded by the European Society of Intensive Care Medicine and will be the largest non-commercial randomised controlled trial due to the substantial number of centres required to deliver the target number of patients. It represents a new and fundamental step for intensive care medicine in Europe. Recruitment will continue until January 2013 and interested clinicians from intensive care units worldwide can still join this important collaboration by contacting the Trial Coordinating Team via the trial website http://www.eurotherm3235trial.eu. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34555414.

Acknowledgments: We thank the participants of this study, community pharmacists who recruited women for the study, and health-care professionals at the sexual and reproductive health service clinics who assisted with the study implementation. We thank Deirde Sally, Nicola Stewart, and Maria Nunez for the support with study implementation at the local site in London and Kristina Saunders for support with the process evaluation. We also thank Sarah Cameron and Lorna Aucott (senior statistician, the Centre for Healthcare Randomised Trials) for support and Katherine Lewis, Laura Flett, and Judith Parker for trial management support. List of study pharmacies in Edinburgh: Newington Pharmacy, Boots Princes Street, Boots Shandwick Place, Boots Earl Grey Street, Boots Gyle, Boots St Patrick Street, Boots Multrees Walk, Boots Ocean Terminal, Boots Edinburgh Fort Retail Park, Boots Cameron Toll, Boots Craigleith, and Bristo Square Pharmacy. List of study pharmacies in London: Peace Pharmacy, Westbury Chemist, Baba Chemist, Lings Chemist, Streatham Day Lewis, Morrisons—Aylesham Centre, Evergreen Pharmacy, Greenlight Pharmacy, Sandylight Pharmacy, Greenfields, JP Pharmacy, Boots Goodge Street, Boots Tottenham Court Road, and Boots Holborn. Additionally, Asda Pharmacy (Perth), Boots High Street and Boots Perth Road (Dundee). List of sexual and reproductive health clinics: Chalmers Sexual and Reproductive Health Service, NHS Lothian (Edinburgh), Tayside Sexual and Reproductive Health Service, Ninewells Hospital (Dundee), Camberwell Sexual Health Centre, Mortimer Market Centre, the Margaret Pyke Centre, and the Archway Centre (London). Declaration of interests: STC reports grants from the National Institute for Health Research (Health Technology Assessment [NIHR HTA] Programme), during the conduct of the study. AG is a consultant to HRA Pharma. AR reports receiving research grants from Gilead Sciences, Bristol-Myers Squibb, AbbVie, and Roche; honorariums from Gilead Sciences; and personal fees from AbbVie. LM and SP report funding from the UK Medical Research Council and Scottish Government Chief Scientist Office (Central Statistics Office) at the University of Glasgow (MC_UU_12017/11, SPHSU11). PB is a clinical director of the not-for profit community interest company SH:24, that provides online sexual health services in partnership with the UK National Health Service. KC reports being an employee of Boots UK, during the conduct of this study. AleM reports grants from NIHR HTA, during the conduct of this study. AleM is a clinical support bank midwife for SH:24 and a research midwife at Oxford University. JN was a deputy chair of the NIHR HTA General Board Committee (2016–19). All other authors declare no competing interests. This research is funded by the NIHR HTA project 15/113/01. ; Peer reviewed ; Publisher PDF