Spring 2004
8,500 patients randomised
CRASH Co-ordinating Centre has moved to new offices within the London School of Hygiene & Tropical Medicine. Most contact details will remain the same, but please note the new postal address at the end of this Newsletter. All personal extension numbers have also changed. Please use the main CRASH Trial telephone number until further notice, also at the end of the letter.


I am absolutely sure that the main reason why CRASH collaborators are prepared to take on the extra work of participating in the trial is that they want to improve outcome for patients with brain injury. I am also sure that all of us would have preferred to have prevented the brain injury from occurring in the first place. In this regard, I would like to draw your attention to a hugely important initiative by the World Health Organisation (WHO). For the first time in the history of the WHO, World Health Day 2004 will be devoted to road safety. Traditionally held on 7 April, World Health Day is one of WHO’s key advocacy tools for reaching out and engaging the public in discussion and debate on important health issues. The slogan for the day in 2004 is Road safety is no accident and on 7 April 2004 the World Report on Road Traffic Injuries will be launched. The report covers the fundamental concepts and prerequisites of road traffic injury prevention, the impact of road traffic injuries, key determinants and risk factors, intervention strategies and recommendations. A global campaign for road safety will follow World Health Day during which time WHO and its partners will give technical support to countries to implement the recommendations of this report. Everyone taking part in the CRASH Trial knows the terrible impact of road traffic injuries on patients and their families and so everyone should do whatever they can to draw attention to this report and do their bit to ensure the implementation of its recommendations. More details about the report can be obtained on the World Health Day website


Before the next newsletter is sent out the trial collaborators will have randomised 10,000 patients. This is a huge achievement and everyone who has contributed to the success of the trial so far should feel proud of their contribution. Prior to CRASH, the largest head injury trial included only about 1,000 patients - far too small to detect clinically important treatment effects. Not only that, the CRASH collaborators have ensured that to date early outcome data are over 95% complete and that six month follow-up rates are in the nineties. Regardless of whether or not corticosteroids improve recovery, answering the trial question and conducting the first large scale randomised controlled trial in head injury will be a major milestone in the area of clinical medicine that is of enormous public health importance. Thanks to all.

Ian Roberts



Did you hear about the new buzz in the CRASH Trial? No? Well here is the scoop… right from the source. To keep up with the revolutionary pace of the New Year, CRASH plans to introduce a revolutionary way to send in data. Presenting the Electronic Data Form (EDF).

Electronic? What does it mean? Does it mean more work for me as a collaborator?
Oh no!! Electronic means you can forget the current method of entering data into Word-forms and remembering to save them as password protected files. Forget the days when you overwrote existing data by mistake. You can forget about running to the fax machine to send in the forms. EDFs have been designed with the users in mind. They have been designed to be simple but efficient.

This all sounds exciting but what do I as a collaborator have to do?
All you have to do is open the relevant form, enter the relevant data and click on Save. What happens internally is that a password protected Excel file is created automatically for you. You then email the Excel file to and your data is automatically uploaded into the main system. You can send in your data by just sitting at your desk and clicking a few buttons. Doesn’t that sound real easy?

Hmmm that sounds easy enough. Gimme more!!
Well, CRASH plans to introduce three EDFs. They are Electronic Patient Entry Form, Electronic Early Outcome Form (shown below) and Electronic 6-month follow-up form. They will replace the existing Word-forms. The forms are all ready to go and will be introduced in February. So let’s get out of the Age of Dinosaurs and get into the Electronic Age.

Leena Narayanan

News from the Co-ordinating Centre

Lin Barnetson
Data Manager

I am especially pleased to be joining the CRASH team at such an exciting stage in the trial. As the number of patients randomised rises exponentially, the data management team will be increasingly involved in ensuring that the mechanisms of acquiring and validating data are optimal for all with the continuing emphasis on simplicity and accuracy. With many years experience of clinical research data management (Oxford Project to Investigate Memory and Ageing) and implementation of hospital information systems (Royal Marsden Hospital) I am aware of the onus on hospital staff in providing additional information for research purposes and fully appreciate the amazing contribution of all the CRASH collaborators. The year ahead should prove to be both challenging and satisfying and I am looking forward very much to joining the team.

Leena Narayanan
I am the new Programmer with the CRASH Trial and am very excited to be a part of this team. I bring to this role over five years experience of working on a wide range of technologies and software platforms. This is my first experience of working on a clinical trial and I find it very challenging. My main responsibility is maintaining and developing the trial database. I will also be maintaining and developing the CRASHnet website. My first priority to date has been the development of Electronic Data Forms (EDF). These forms have been introduced with the aim to seamlessly integrate data from collaborators into the central database. The EDFs have been designed to be easy to understand and use. My next project will be to bring about changes in the CRASHNet website. I will be trying to add functionality to the existing website based on the suggestions and feedback we have received. I am motivated by the determination and enthusiasm of my colleagues and this gives me the drive to make a success of my role.

Julia Abernethy
I have joined the CRASH Team as a part time data assistant. My background is in archaeology and anthropology as an undergraduate and more recently population genetics as a PhD student (I am currently writing up my PhD during my time off from CRASH!). My task is to do the second entry of all Early Outcome Forms and 6-month follow-up forms that need to be entered. This makes sure that all data stored in the database is accurate. As described elsewhere in this newsletter the trend is to move towards electronic forms which do not need manual entry, but until every collaborator has switched to these, I will have lots to do!

Josephine Bardswell
Trial Assistant

I joined CRASH in December 2003.  I have previously worked in university administration, but this role is my first involvement with a clinical trial. I am working in several administrative aspects of the trial, including assisting with processing payments and other finances, and sending trial materials to hospitals starting and already involved in CRASH.

Here is a further selection of photos of collaborating teams.
Please keep them coming.

Hospital Jose Carrasco Arteaga
with Marcelo Ochoa

Sanglah General Hospital
with Nyoman Golden

Instituto de Prevision Social, Asuncion
with Carlos Ortiz

University Hospital Bern
with Peter Sommer

Hospital San Bernardo
with Enrique Vergara

Waldviertelklinikum Standort Horn
with Walter Buchinger

Hope Hospital, Manchester
with Gabby Lomas

Hospital General de Morón
with Angel Lacerda

Hospital Habib Thameur
with Zouheir Jerbi

Republican Hospital, Tbilisi
with Tamar Gogichaisvili

NSCB Medical College, Jabalpur
with Y R Yadav

Hospital General de La Palma
with Luis Ramos Gómez

Thank you to all the teams listed below for your tremendous achievement. Without your contribution the CRASH Trial would not be able to achieve its goal. Also a warm welcome to all new collaborators.

New ethics approvals

  • Jorge Alberto Dudzinskas, Hospital San Vicente de Paul, Argentina
  • Inés Zavala, Hospital de Niños Dr Roberto Gilbert, Ecuador
  • George Kharchilava, Tbilisi 4th Hospital, Georgia
  • Nelanuthala Mohan, Apex Hospital, Visakhapatnam, India
  • Jayant Chawla, Government Medical College, Amritsar, India
  • Jayant Chawla, Hartej Maternity and Nursing Home, Amritsar, India
  • Y R Yadav, Johri Hospital, Jabalpur, India
  • Y R Yadav, Marble City Hospital & Research Centre, India
  • Y R Yadav, National Hospital Jabalpur, India
  • Syaiful Ichwan, Kardinah Hospital, Indonesia
  • Enrique Paz Rojas, Hospital "Guillermo Almenara Irigoyen", Peru
  • Luis Antonio Cabrera Salazar, Hospital "Victor Ramos Guardia" de Huaraz, Peru
  • Roberto Patiño Gardenas, Hospital Emergencia "Jose Casimiro Ulloa“, Peru
  • Marco Gonzalez-Portillo Showing, Hospital Nacional "Dos de Mayo“, Peru
  • Mario Suarez Lazo, Hospital Nacional Hipólito Únanue, Peru
  • Ivan Macuga, NsP Zilina, Slovakia

New randomisers

  • Nikolin Filipi, University Hospital “Mother Teresa”, Albania
  • Ricardo Plata, Hospital Universitario del Valle, Colombia
  • Peter Ullrich, Städtische Kliniken Offenbach/Main, Germany
  • Dilip Panikar, Amrita Institute of Medical Sciences, Cochin, India
  • Yashbir Dewan, Christian Medical College, Ludhiana, India
  • T V S Reddy, Gowri Gopal Superspeciality Hospital, Kurnool, India
  • Dilip S Kiyawat, Hirabi Cowasji Jehangir Medical Research Institute,
    Pune, India
  • Kolluri Venkatarama Sastry, National Institute of Mental Health and Neuro Sciences, Bangalore, India
  • Sanjay Gupta, Sri Sai Hospital, Moradabad, India
  • M M Qureshi, Aga Khan Hospital, Kenya
  • Fadzli Cheah Abdullah, Ipoh Specialist Hospital, Malaysia
  • K S Oluwadiya, LAUTECH Teaching Hospital, Nigeria
  • Megahid Eldawlatly, King Khalid National Guard Hospital, Saudi Arabia
  • Luis Ramos Gómez, Hospital General de La Palma, Spain
  • Véronique Laloë, Point-Pedro Base Hospital, Sri Lanka
  • Sylvia Fitzal, Wilhelminenspital der Stadt Wien, Switzerland

10 patients

  • Fatos Olldashi, National Trauma Centre Hospital, Albania
  • Keith Hickling and Mandy Tallott, Gold Coast Hospital, Australia
  • Walter Buchinger, Waldviertelklinikum Standort Horn, Austria
  • Hernando Delgado, Hospital Civil de Ipiales, Colombia
  • Rafael Perez, Hospital El Tunal, Colombia
  • Hubiel López Delgado, Hospital Provincial Docente "Manuel Ascunce Domenech", Cuba
  • Boris Zurita Cueva, Hospital de la Policia Guayaquil, Ecuador
  • Haroon Pillay, Baby Memorial Hospital, Kozhikode, India
  • P V Ramana, Care Hospital, Visakhapatnam, India
  • Nadakkavvkakan Kurian, Jubilee Mission Hospital, Thrissur, India
  • K S Maheswari, Maheswari Orthopaedic Hospital, Jamnagar, India
  • R R Ravi, Medical Trust Hospital, Kochi, India
  • Sojan Ipe and P K Manoj, MOSC Medical College Hospital, Kolenchery, India
  • Varinder Khosla, Postgraduate Institute of Medical Education and Research, Chandigarh, India
  • Krishnamurthy Sridhar, V H S Hospital, Chennai, India
  • T O Odebode, University of Ilorin Teaching Hospital, Nigeria
  • B B Shehu, Usmanu Danfodiyo University Teaching Hospital, Nigeria
  • Jozef Firment, FNsP Kosice, Slovakia
  • Bill Bailey and Nancy Loveridge, Chesterfield & North Derbyshire Royal Hospital, UK
  • John Thurston and Emma Brown, Darent Valley Hospital, UK

50 patients

  • Arturo Arias, Hospital Erasmo Meoz, Colombia
  • Ahmed Yehia Elhuseny, Zagazig University Hospital, Egypt
  • Y R Yadav, NSCB Medical College, Jabalpur, India
  • Barbara Fogg and Chris Moulton, Royal Bolton Hospital, UK
  • Utham Shanker and Sam Funnell, Eastbourne District General Hospital, UK

100 patients
Luiz Nasi and team
Hospital de Pronto Socorro de Porto Alegre, Brazil

100 patients
Enrique Vergara and team
Hospital San Bernardo

200 patients
Hussein Khamis and team
Mataria Teaching Hospital

200 patients
Gabby Lomas and team
Hope Hospital

CRASH Co-ordinating Centre, LSHTM, Keppel Street, LONDON WC1E 7HT

Tel +44(0)20 7299 4684 - Fax +44(0)20 7299 4663


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