3,000 PATIENTS RANDOMISED
The meeting provided an excellent opportunity to discuss issues of concern and to share experiences about how to take the trial forward. Every collaborating hospital presented their experience of the trial to date and their plans to increase patient recruitment and identify new hospitals in order to continue to expand the trial network. These plans are already underway and yielding results. The meeting also provided an opportunity for on-site data audit which confirmed that the standard of data throughout was excellent. The overall conduct of the trial in Nigeria was extremely impressive a testament to the integrity, diligence and sheer dedication of our Nigerian collaborators.
Ile-Ife was a marvellous setting for the meeting at the superb and enormous university campus set within beautiful parklands and forest also the home of many thousands of bats which at dusk swooped around the trees so thickly that night appeared to have come sooner than it ought. Thanks again to Edward Komolafe and all who participated for making this meeting such a resounding success.
From left Dr Aminu & Dr Khalid from Ahmadu Bello UTH, Lin Barnetson, Dr Ndoma-Egba from Calabar, Ian Roberts, Dr Olaomi from Abuja, Dr Ngim from Calabar
progress now published on PLoS Clinical Trials
the Evidence Base for Trauma Care: Progress in the International CRASH-2
|new faces in the trials coordinating centre|
started working with the Trials Co-ordinating Centre in August 2006 and
help with all aspects of the trials from start to finish. I have previous
experience working in clinical trials and a PhD in Epidemiology, but I am
new to trauma and so excited to learn more about this fascinating area and
to be able to help in such an under-researched field. If you have any questions
please feel free to contact me as I am here to help."
Pauline Brocard, Research Fellow
previous role was an administrative one, but I have recently gained a Masters
in Public Health Nutrition and am looking forward to making a positive contribution
as part of the CRASH2 administrative team."
Eni Balogun, Clinical Trial Associate
High dose mannitol: An effective treatment for head injury... but are the data real?
Each year, worldwide, millions of people are treated in emergency departments following severe head injuries. Mannitol, an osmotic diuretic, may be effective in reducing raised intracranial pressure after head injury and is often used in the treatment of head injury patients.
Between 2001 and 2004, three reports were published by Dr Julio Cruz and colleagues presenting the results of three clinical trials comparing early high dose mannitol with conventional doses of mannitol in patients with head injury. The trial results showed that high dose mannitol was dramatically effective in reducing mortality and disability. The results were incorporated into a systematic review that was published on the Cochrane Library. The review concluded that high dose mannitol appears to be preferable to conventional dose mannitol in the acute management of comatose patients with severe head injury.
However, earlier this year, Dr Jorge Mejia Mantilla, the Colombian National Co-ordinator of the CRASH-2 trial, communicated to the Cochrane Injuries Group that there were concerns about the Cruz reports after hearing from Brazilian neurosurgical colleagues that there were grounds to question the integrity of the Cruz trials. In response, the Cochrane Injuries Group undertook a detailed investigation in which attempts were made to find out where the patients were recruited and to access the original trial data for external validation.
Despite considerable efforts the Group is unable to provide reassurance about the integrity of trial data. Specifically, it was unable to determine if or where the trials had taken place. Consequently, the trials in question have been removed from the systematic review. The Cochrane Injuries Group is grateful to Dr Mejia Mantilla for bringing these concerns to our attention.
If you are interested in becoming a member of the Cochrane Injuries Group and/or in undertaking a systematic review, email the Review Group Co-ordinator Katharine Ker at firstname.lastname@example.org
|CRASH2 teams around the world|
"For our emergency team it is a great honour to participate in this international research initiative in which there is a common interest in finding reliable answers for trauma patients with significant bleeding. Come on CRASH-2 Team count on us for future CRASH Studies!"
Andrés Villarreal, Fundación Hospital San Jose de Buga, Colombia
decided to participate in the CRASH2 Trial because we are located in an
area where we receive a great influx of trauma patients. We know the CRASH
Coordinating Team from the CRASH1 Trial and consider it to be one of the
best. The result of the CRASH2 Trial will be very useful for our patients,
our guidelines and also for continuing doing research in countries
such as ours, with a large number of trauma patients but with few research
Andrés Rubiano, Hospital Universitario de Neiva, Colombia
CRASH2 trial is now up and running in two hospitals in Georgia, with another
two awaiting final approvals. The trial has made an excellent start at the
Neurosurgery Department of Tbilisi State Medical University Central Clinic.
It is of our great honour that our team is participating in the large international
clinical trial. It is very important for us because in Georgia, as in many other regions in the world, trauma is a major cause of death and disability, and blood transfusion as a life saving procedure is not without complications. To help improve outcomes following traumatic injuries thats the reason why we joined the CRASH2 trial.
The CRASH2 trial will answer an important question which could have worldwide application in trauma management and there is every reason to expect that this trial will be a success.
Tamar Gogichaishvili, Georgia national co-ordinator
for randomising their
to the international trauma network
countries with 100+ recruitment
Background photo: Spedali Civili di Brescia, Italy
Diwaniyah College of Medicine