The CRASH-2 trial has started
was arguably one of the most important clinical trials ever conducted. It
recruited 17,000 patients with myocardial infarction and clearly demonstrated
the beneficial effect of thrombolysis on mortality. Large trials in cardiovascular
disease are now common and, as a result, there are many proven effective
treatments. Trauma is a completely different story. There are very few large
trials and few known effective treatments. This is a real tragedy because
trauma is second only to HIV as a cause of death in young people world-wide.
As Brigitte Chaudhry, President of the European Federation of the Victims
of Road Traffic Injuries and member of the CRASH-2 trial steering committee
points out the lack of effective treatments for trauma victims adds
insult to injury.
The CRASH trial of corticosteroids in head injury was the first large scale trial in trauma care. It showed that a treatment that had been used for over thirty years probably did more harm than good. The results will improve the management of patients with head injury around the world. But perhaps the main contribution of the CRASH trial was not this particular result but the fact that doctors and nurses from over 400 hospitals in nearly 50 countries worked together to improve the care of trauma patients and together showed that large scale trials in critically ill trauma patients are possible and important.
CRASH-2 is an international, multi-centre, randomised, placebo controlled trial of the effect of the antifibrinolytic agent tranexamic acid on death and transfusion requirement in bleeding trauma patients. It is supported by the World Health Organization, has multi-centre research ethics approval for the UK and an MHRA clinical trials approval. Treatment packs are now being prepared and will soon be shipped out to collaborating hospitals so that we can start recruitment in March 2005. A large number of CRASH trial collaborators have already signed up to CRASH-2 and are applying for local ethics committee approval. We also look forward to many new collaborators joining this new trial.
A simple and widely practicable treatment that reduces blood loss following trauma might prevent thousands of premature trauma deaths each year and could also reduce exposure to the risks of blood transfusion. Blood is a scarce and expensive resource and there are major concerns about the risk of transfusion-transmitted infection. There is good evidence that anti-fibrinolytics reduce blood loss in surgery but the trials in trauma have been too small to either confirm or refute a clinically important benefit.
will answer this question by recruiting 20,000 patients. It will take
several years and the collaboration of hundreds of health professionals
world-wide but we know that it is possible and we know that the knowledge
it will provide will be one more step towards improving the care of trauma
victims. Will CRASH-2 do for trauma patients what ISIS-2 did for heart
patients? There is only one way to find out. WELCOME
TO THE CRASH-2 TRIAL.
trial was recently introduced to doctors and nurses in Colombia, some of
whom also took part in the CRASH Trial. Miguel Arango continues as a Regional
Co-ordinator for the NLAC region.
National meetings are also planned in Egypt and Thailand in March and April.
|WHY DID I JOIN?|
|I should probably
tell you how scientific CRASH1 was, tell you how we answered an old question
never solved before or tell you how important it will be to find an answer
for bleeding in trauma. But I dont care about all this. Others will
do that much better than me. CRASH1 begun slowly but grew up rapidly to
become not only a strong study but, most of all, a great story of friendship.
We built a net over the world - a scientific one - and this may not unravel
with the end of CRASH1. It was not about tens of countries and hundreds
of hospitals - it was about thousands of people getting together, surely
with a lot of hard work, but most of all with the pleasure of entering a
great family, and with fun. It is possible to combine science with fun and
friendship, although this is becoming very rare in our world.
Thats why we have to take care of this net. Thats why Im going for CRASH2.
GUY MAZAIRAC, BELGIUM
as much as it is a life saving procedure, is not without complications.
These complications are directly related to number of transfused units.
If a simple intervention like giving a drug early on, upon receiving the
patient in the A&E, may help to decrease the severity of bleeding, give
time for appropriate control of bleeding source and decrease number of transfused
units, this is likely to reflect positively on mortality and morbidity of
such a global health problem.
Mataria Teaching Hospital and other hospitals in Egypt consider that finding answers to medical problems of common interest and of high magnitude can only be achieved via international cooperation in a well organized study such as CRASH2.
HUSSEIN KHAMIS, EGYPT
Nowadays, traumatic injuries are strongly responsible for the death of young people all over the world. To participate in CRASH2 is an excellent opportunity to join a very great effort: helping to improve outcomes following traumatic injuries.
CARIDAD SOLER MOREJÓN, CUBA
Bleeding is one of the major contributing factors to unfavourable treatment outcome in any single or multiple organ injury for our trauma patients worldwide. Whilst we know the definite benefit of antifibrinolytic agents in reducing blood loss in many fields of elective surgery, it is a great challenge to gather reliable evidence of benefit to trauma patients by participating in CRASH2.
SURAKRANT YUTTHAKASEMSUNT, THAILAND
A few years ago, interesting people from England organized a group of doctors around the world to join the CRASH trial. A question about steroids on head injury was a medium to share each others experiences on science. A great opportunity to take part in a medical research adventure was calling us and the way we manage our practice changed, at my hospital, to think beyond medicine. The journey was long and intense, more than 50 countries and 400 hospitals participated on CRASH trial. We made an icon on history of medical treatment of head injury. At the end of the day we found great people and outstanding doctors, running down the same road to improve health care and the life of our patients. We are now very enthusiastic because a new research has been traced to become one of our goals. Trauma mortality is high and devastating - an enemy. We invite you to fight with us against it and share your knowledge with us and find out the truth of medicine.
MARIO IZURIETA ULLOA, ECUADOR
There are already almost 200 NEW centres who have expressed interest in joining. Collaborators in Argentina, Belgium, Ecuador, Colombia, Cuba, Egypt, India, Indonesia, Nigeria, Romania, Saudi Arabia, Spain and Thailand are preparing to apply for national approval.
About 50 centres have submitted
their ethics application and already there are 6 hospitals with ethics
approval, waiting for the trial to start:
Jorge H Mejia-Mantilla
NEW PAGES ON TRIAL WEBSITE
The contacts pages will be rebuilt to accommodate a page for each participating country. Please send photographs of the trial team in your hospital, with names, to be published on your country page.