The Data Monitoring Committee met last month to review outcome data on the 1180 patients recruited up to the end of February 2001.  It was the view of the committee that the data provided no cause to recommend any changes to the study procedures or to plans for expansion of patient recruitment.  The committee commended the trial collaborators on their success with recruitment and with follow-up.  This is excellent news!  The CRASH trial is now the largest head injury trial ever conducted and the rate of recruitment is increasing steadily.  Very soon there will be more patients in the CRASH trial than in all previous trials of corticosteroids in head injury combined.  We have a long way to go but we are on target.

Crash Protocol Published on BioMed Central 

BioMed Central is an internet based medical journal that publishes peer reviewed research across all areas of biology and medicine, with immediate, barrier-free access for all.  Earlier this month the CRASH Trial protocol was accepted for publication 
(http://www.biomedcentral.com/1471-227X/1/1). The protocol was peer-reviewed by a basic scientist and a professor of neurosurgery.  The neurosurgeon was particularly flattering:

“In summary, this study must be considered a milestone in drug research in head injury; for the first time, the concentration to simple entry criteria and outcome data allows the collection of the high number of patients required to achieve a real evidence based basis for steroid indication in an independently organised world-wide investigation.”

Onwards! 

» Petr Svoboda and Jiri Ochmann at Research Institute for Special Surgery and Trauma, Czech Republic

» Guy Mazairac at Centre Hospitalier Regional de Namur, Belgium

» Hussein Khamis at Mataria Teaching Hospital, Egypt

» Silke Ludwig at University Hospital of Zurich, Switzerland

» David Yates and Gabby Lomas in Hope Hospital, UK

» Nigel Brayley and Jane Lynch in Colchester General Hospital, UK

Half of all the patients recruited in the last four weeks were enrolled by these six centres. 
Many congratulations! 

Ethics approval has been obtained by Julia Harris in Chelsea and Westminster Hospital and Samy Massoud in St Helier Hospital in the UK, as well as Juan Nava, Hospital Mútua de Terrassa in Barcelona, Spain.  

We look forward to recruitment starting in these centres very soon - welcome aboard!