Newsletter
Issue 5 Winter 2006

CRASH2 logo
1,000 PATIENT PAPER SUBMITTED

Regional focus - COLOMBIA

 

 

 

Jorge Mejia Mantilla, Colombia National Co-ordinator

Jorge Mejia Mantilla

As in many other regions in the world, trauma is a major cause of death and disability in Colombia. Although the government recognises the problem it has not been a priority to research agencies. The economic impact of trauma on patient care is so high that some hospitals are overwhelmed and can hardly find resources to keep working.

The emergency system in most Colombian cities is loosely organised. The care of trauma patients is centred on public hospitals where most patients are treated by top level university personnel with high commitment and formation, but they have scarce resources to assure the care of severely injured patients. Finding cheap and efficacious tools to treat those patients should be a major goal of our research efforts. Nevertheless, physicians and nurses working in those university hospitals have demonstrated their interest and capacity for research.

The research in trauma is difficult to carry out; not just the problem of funding it but the design of a trial can be subject to disagreement. The CRASH trials are a great example of the research we need: with a very clear and simple design they have approached controversial issues.

Colombia participated in the first CRASH trial with an important number of centres and contributed with a large number of patients. Now, the second mega-trial in trauma conducted by the CRASH trial group is on the way to answer a very important question in trauma care. Clinicians embraced this trial with a great interest and keenness, but having the approval of ethics committees and regulatory agencies has been a hard task, partly because there is a low research activity in the country and by consequence a misunderstanding about what research means; partly because the CRASH trials are different to most other trials designed to evaluate new medications in more controlled settings. The uncertainty principle is a relatively new tool in research and some research committees in Colombia are not aware about its meaning and usefulness.

I would like to highlight the work of various collaborators like Carlos Morales, Juan Diego Ciro, Carolina Gómez, María Isabel Calle and Hernán Delgado for their enthusiasm and celerity in starting the trial in their centres and for keeping the pace on recruitment and reports to the London centre.

Alexander Sanclemente of Hospital Universitario San Vicente de Paul in Colombia randomised the 1,000th patient into the trial and the hospital has received the well deserved £200 prize.


INTRODUCING THE INTRANET FOR COLLABORATORS
Intranet button image

We are very happy to announce that your Intranet is now fully functional and take this opportunity to invite you all to visit the site.

The Intranet is accessed from the CRASH2 homepage by clicking on the button INTRANET FOR COLLABORATORS. You will need a username and password which you can get from us by email.

Besides adding new features, such as materials ordering facility, we shall keep your Intranet updated with trial information of particular interest to collaborators and welcome your suggestions as to what you would find useful. At present we have various guidance notes, PowerPoint presentations, patient leaflets in over 30 languages and the latest versions of the electronic entry and outcome forms, all of which may be downloaded. Completed data forms may also be uploaded direct to the server which is the most secure method of sending data to us. We were delighted to receive our first uploaded forms sent in by Fukuoka Hospital in Japan and Care Hospital in India.

Of special interest to many of you will be the Good Clinical Practice training package. If you do not already possess a certificate in GCP training then do complete the on-line quiz at the end of the training package. Certificates will be issued to those who pass with 75% and above.

Please visit the site and we look forward to hearing your suggestions and comments.

Intranet homepage

Graph - number of hospitals per country

ALL THESE CENTRES RANDOMISED THEIR FIRST PATIENT WITHIN 10 DAYS OF RECEIVING THEIR TRIAL MATERIALS:
Patrick Druwé, Sint-Vincentius Hospital, Belgium
Ji-yao Jiang, Renji Hospital, China
Jorge Mejia Mantilla, Fundacion Clinica Valle del Lili, Colombia
Juan Ciro, Clinica las Americas, Colombia
Marcelo Ochoa Parra, Hospital Jose Carrasco Arteaga, Ecuador
Mario Izurieta, Hospital Luis Vernaza, Ecuador
Hussein Khamis, Mataria Teaching Hospital, Egypt
Tamar Gogichaisvili, Tbilisi State Medical University, Georgia
R R Ravi, Medical Trust Hospital Kochi, India
Wu Hoong Chhang, North Bengal Neuro Research Centre, India
Venkatesh Babu and C Sumathi, Sri Sakthi Hospital, India
Nyoman Golden, Sanglah General Hospital, Indonesia
M Modiba, Dr George Mukhari Hospital, South Africa
Surakrant Yutthakasemsunt, Khon Kaen Regional Hospital, Thailand

Dawn Davis

We welcome Dawn Davis to the CRASH team as assistant trials administrator. She has worked within university administration for a number of years and has a keen interest in health related issues, particularly within the area of research.

Dawn’s role is to support the trial administration dealing with materials, drug stocks, ethics approval processes etc. She says: “I am new to the area of clinical trials and I envisage that over the coming few months my experience on the CRASH2 trial will be both challenging and rewarding.”

Argentina poster
Zulma Ortiz, our National Co-ordinator in Argentina, presented the trial in the 1st Interamerican Conference of Emergency Medicine in Buenos Aires in April.


Cochrane logoCochrane Injuries Group Column

New systematic review: Is rehabilitation after brain injury useful?

There is evidence that multi-disciplinary rehabilitation is effective in the stroke population where older adults predominate. However, the evidence base for the effectiveness of rehabilitation following acquired brain injury (ABI) in younger adults is not established. A Cochrane review1 attempted to assess the effects of multi-disciplinary rehabilitation following ABI in adults, 16 to 65 years. The authors conclude that patients presenting acutely to hospital with moderate to severe ABI should be routinely followed up to assess their need for rehabilitation. Intensive intervention appears to lead to earlier gains. The balance between intensity and cost-effectiveness has yet to be determined. Patients discharged from in-patient rehabilitation should have access to out-patient or community-based services appropriate to their needs. Those with milder ABI benefit from follow-up, and appropriate information and advice.
1Turner-Stokes L, Disler PB, Nair A, Wade DT. Multi-disciplinary rehabilitation for acquired brain injury in adults of working age. The Cochrane Database of Systematic Reviews 2005, Issue 3. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=16034923&dopt=Abstract

WHAT'S YOUR OPINION ABOUT BRAIN INJURY REHABILITATION?

We would like your opinion as to what aspects of rehabilitation are important to improve the outcome of the patients in your country. Email your thoughts to crash@lshtm.ac.uk

Question mark

Iraq flag
CRASH2 has started in Iraq
Diwaniyah Teaching Hospital, established in 1986, is a 452-bed general hospital under the Diwaniyah University College of Medicine. It is the central and only drainage hospital of trauma patients in Diwaniyah province, about 200km south of Baghdad. The average monthly case load is 10,000 patients. The College of Medicine was founded in 1996 and admits on average 45 students per year. Bassim Irheim Mohammad has started randomisation of CRASH2 patients in Diwaniyah and other hospitals in Iraq are in the process of obtaining ethics approvals.
Diwaniyah Hospital Dr Bassim training staff
what’s going on in the UK? UK flag
The CRASH2 trial is now up and running in 11 hospitals in the UK, with another 7 awaiting final approvals. We are the first trial to enter incapacitated patients since the introduction of the new consent legislation. Blazing a trail is always hard work, but there is now a much greater understanding amongst NHS R&D Departments of how the legislation can be translated into a practical approach to emergency care research. The CRASH2 trial will answer an important question which could have worldwide application in trauma management. The trial has made an excellent start, but we still need to take every opportunity to randomise patients in order to reach our target.
CRASH2 teams from around the world

Team at AIIMS

All India Institute of Medical Sciences (AIIMS), with Ashok Kumar Mahapatra

Team at Seveth Day Adventist Hospital
Seventh Day Adventist Hospital, Nigeria, with Herb Giebel
Team at Sri Sakthi Hospital
Sri Sakthi Hospital, India
with Venkatesh Babu and C Sumathi

new randomisers

THANK YOU TO ALL OF THE FOLLOWING FOR CLEARING THE FIRST HURDLE OF RANDOMISING THEIR FIRST PATIENT – MANY MORE TO FOLLOW:

Wilson Gualteros, Hospital Universitario San Jorge, Colombia
Olugbenga Oludiran and Pius Iribhogbe, University of Benin Teaching Hospital, Nigeria
Charles Adeyinka Adisa, Abia State University Teaching Hospital, Nigeria
P V Ramana, Care Hospital, India
Petr Svoboda, Research Institute for Special Surgery and Trauma, Czech Republic
A K Purohit, Nizam's Institute of Medical Sciences, India
Ji-yao Jiang, Renji Hospital, China
M Modiba, Dr George Mukhari Hospital, South Africa
Jorge Loria Castellanos, Hospital General Regional 25, Mexico
Bassim Irheim Mohammad, Diwaniyah College of Medicine, Iraq

new ethics approvals

CONGRATULATIONS AND WELCOME TO THE FOLLOWING NEW COLLABORATORS:

David Mountain, Sir Charles Gairdner Hospital, Australia
Federico Andrés Benítez Paz, Clínica La Estancia, Colombia
Hernan Delgado Chaves, Hospital San Andres de Tumaco, Colombia
A K Purohit, Nizam's Institute of Medical Sciences, India
Bassim Irheim Mohammad, Diwaniyah College of Medicine, Iraq
Jose Alfredo Villatoro Martinez, Hospital General de Chimalhuacan, Mexico
Adefemi Afolabi, University College Hospital Ibadan, Nigeria
Rowland Ndoma-Egba, University of Calabar Teaching Hospital, Nigeria
Branko Ðurovic and Ranka Krunic, Klinicki Centar Srbije, Serbia & Montenegro
Jozef Valky, Faculty Hospital F D Roosevelta, Slovakia
Beata Sániová, Faculty Hospital in Martin, Slovakia
Aktham Yaghi, FNsP Ružinov, Slovakia
Stefan Trenkler, NsP JA Reiman Hospital, Slovakia
Anton Laincz, NsP Poprad, Slovakia
Reitze Rodseth, Grey's Hospital, South Africa
Andrew Webster, Royal Lancaster Infirmary, UK
Michael Hawkins, Medical College of Georgia, USA

special mentions

MANY CONGRATULATIONS FOR THE FOLLOWING OUTSTANDING ACHIEVEMENTS:

250 randomised patients
Hussein Khamis & team at Mataria Teaching Hospital, Egypt

100 randomised patients
Carlos Morales & team, Hospital Universitario San Vicente de Paul, Colombia
Mamdouh Amin, Hany Shokry & team, Aswan Teaching Hospital, Egypt

50 randomised patients
Mario Izurieta & team, Hospital Luis Vernaza, Ecuador
Hesham Elsayed & team, Suez Canal University, Egypt
Yashbir Dewan, Jacob Mathew & team, Christian Medical College, India
Sanjay Gupta & team, Sri Sai Hospital, India


BEST DATA QUALITY
Hussein Khamis of Mataria Teaching Hospital, Egypt, was awarded the prize for best data quality – Many congratulations to him and the Mataria CRASH-team!