Issue 4 Winter 2006

CRASH2 logo

Thanks to hard work by CRASH-2 trial collaborators all around the world, we have now randomised 1,000 patients. This is a tremendous achievement. The CRASH-2 trial already provides ten times more randomised evidence than all previous trials of anti-fibrinolytic agents in trauma patients. The trial collaborators have shown that it is possible to conduct large scale randomised controlled trials in trauma patients that answer important clinical questions. The CRASH-2 trial question is important for two reasons.

First, there is the possibility that tranexamic acid, which is cheap and easy to use, might reduce mortality in trauma patients. Second, there is the possibility that tranexamic acid might reduce the need for a blood transfusion. In all countries blood transfusion puts patients at risk of adverse transfusion reactions, and in many transfusion puts patients at risk of HIV, Hepatitis B and C and other serious blood borne infections. Here is a letter of support we recently received from the WHO Blood Transfusion Safety Team. Please show this letter to the head of blood transfusion at your hospital since it is essential that they understand the importance of the trial and that they help you as much as they can.

The importance of the CRASH-2 trial has also been recognised by The Lancet. Last year we sent the CRASH-2 trial protocol to the Lancet for external peer review. The protocol was accepted by the Lancet and can be viewed here.

This is what the external reviewers said about the trial:

Reviewer 1: It will probably not be a surprise for you, but I like the study design of CRASH-2 very much. The study addresses a relevant question, will include a sufficiently large number of patients, and looks for clinically relevant outcomes.

Reviewer 2: In my opinion, the protocol CRASH-2 is very well planned, feasible, and suitable for giving useful information on trauma management. I also think that the results of this study would concern all medical specialists involved in trauma care and consequently would be probably worth publication in a general clinical journal like Lancet.

Reviewer 3: Although I would argue that a trial of this magnitude should only proceed following a pilot study that confirmed the likely baseline mortality rate, the trial’s feasibility, an estimate of the likely treatment effect and that the study treatment was safe in this population, it seems highly likely that the trial will be completed. If completed the trial should be published in a widely read general medical journal. Trauma patients are treated by clinicians from many specialty groups, and publication in a specialty journal would likely mean that other interested clinicians would be unaware of the study results.

Reviewer 4: What can be said about this protocol? They have already obtained an EudraCT number. They have Sir Richard Peto in their Steering Committee. The investigators have addressed the issue of financial support of the trial. Moreover, they are on the “leading edge” by acknowledging that CRASH-2 collaborators are key to the trial’s success and, as such, will be authors on the main publications derived from the trial.

The final comment of the fourth reviewer is particularly relevant and absolutely correct. The success of the trial is entirely dependent on the efforts of the collaborators. Fortunately, the CRASH-2 trial network is the best network of trauma trialists anywhere in the world and so, although it will involve a lot of hard work, there is every reason to expect that this trial will be a success.

recruitment by country

Recruitment by country

48 hospitals in 15 countries are now actively recruiting patients. Another 52 hospitals have ethics approval and are getting ready to start. Special thanks to the highest recruiting teams (for other achievements see the back page):

Mataria Teaching Hospital, Egypt – 177

Hospital Universitario San Vicente de Paul
Colombia – 62

Aswan Teaching Hospital, Egypt – 56

Hospital Luis Vernaza, Ecuador – 55

Sanglah General Hospital, Indonesia – 39

what in the world is going on?
See here how the trial is developing in various parts of the world click or click on the COLLABORATORS title on the trial website. We would welcome photographs of the trial happening in your hospital.

Christian Medical College team
Christian Medical College & Hospital, Ludhiana India, is proud to be one of the participating centers for the CRASH-2 trial. As all the documentation and procedures are straightforward and simple, we really do not waste any extra time in carrying out the study. We were pleasantly surprised to know from the CRASH-2 Co-coordinating Centre that we are one of the top recruiters for the trial in India; credit goes to the whole team, my colleagues from neurosurgery, general surgery, orthopaedic surgery, junior doctors and nursing staff of Trauma Centre. Ian, thanks for your encouragement!
Yashbir Dewan, Christian Medical College, India

Fukuoka team

It is of our great honour that our team in Fukuoka University Hospital is participating in this large international clinical trial. The emergency department is playing one of the most important roles in this hospital, located in the South-Western part of Fukuoka city with 1.3 million population. The representative doctor, Akira Murai, is leading the staff to find suitable patients, receive a consent, and give the treatment in our emergency rooms day by day. Join with us in this invaluable study which we hope will result in a gift for human beings.
Masayoshi Abe, National Coordinator, Japan
Edward Komolafe
Nigeria, a West African country, is the most populous black nation in the world with a population of about 130 million. Due to various instabilities in the politics and policies the health system is grossly under funded and under equipped. Few hospitals in the country participated in the last CRASH study but this time efforts are being made to involve as many hospitals as possible and also to have a good spread in the country. Nigeria was among the first nations to start recruiting for the CRASH2 study. However, the progress has not been encouraging due to some factors, including incessant strike actions in the government services, hospitals in particular, lack of laid down research rules in many centres, no definite trauma department with permanent staff in majority of the centres, and infrequent and epileptic power supply with limited access to the internet. We hope that situations will improve in the country to facilitate more cooperation with the collaborators who have indicated their interest to participate in the study.
Edward Komolafe, National Co-ordinator, Nigeria

Interested in trials? Then you’re also interested in Cochrane systematic reviews!
Every trial begins and ends with a systematic review. The MRC CRASH trial was initiated after a Cochrane review highlighted the absence of evidence for the effectiveness of The use of corticosteroids in traumatic brain injury. The completion of the trial and incorporation of the findings into the systematic review now means that we have evidence, in this case evidence of the ineffectiveness of corticosteroids. Similarly, the CRASH-2 is motivated by the need for evidence on the effectiveness of anti-fibrinolytics in trauma patients, again highlighted by a Cochrane review.
Cochrane logo

These systematic reviews (‘Corticosteroids for acute traumatic brain injury’ and ‘Anti-fibrinolytic agents for acute traumatic injury’) are just two out of the 66 completed reviews published by the Cochrane Injuries Group (CIG). The CIG is one of 50 groups based throughout the world working within the Cochrane Collaboration, an international non-profit independent organisation dedicated to making up-to-date accurate information about the effects of healthcare readily available worldwide.

is to prepare, maintain and promote the accessibility of systematic reviews in the prevention, treatment and rehabilitation of traumatic injury. Cochrane reviews are systematic assessments of evidence of the effects of healthcare interventions, intended to help people to make informed decisions about health care, their own or someone else's. Cochrane reviews are needed to help ensure that healthcare decisions can be informed by high quality timely research evidence.

Even after publication on The Cochrane Library, reviews remain as ‘living’ documents, undergoing regular updates to incorporate new research. The CIG has already published 66 reviews and 50 more are in progress, but there are still many more to do. With the increasing global public health burden of injuries in terms of mortality and disability it is hugely important that the interventions for prevention, treatment and rehabilitation of injury are based on sound evidence for effectiveness as assessed in systematic reviews.

We are always pleased to hear from those willing to contribute to the work of the Group, either through acting as peer referees or translators and especially those interested in authoring a review. There are a variety of resources and training available and authors receive continued support and guidance from the editorial team throughout the process. There are also opportunities to assist with the updating of existing reviews to ensure that they reflect the current evidence.

For further information on the CIG and its reviews, visit or email the co-ordinator Katharine Ker.

Katharine Ker

congratulations to recruiters with highest monthly average

A fantastic 22.1 patients per month have been randomised in Mataria Teaching Hospital in Egypt by Hussein Khamis and his team.

Hospital Universitario San Vicente de Paul in Colombia have randomised on average 12.4 patients per month by Carlos Morales and team.

Both outstanding achievements!

well done new randomisers

Arben Banushi, Spitali Civil Durres

Patrick Druwé, Sint-Vincentius Hospital

Argemino Gallego Ossa, Hospital General de Medellin
Carlos Morales, Hospital Universitario San Vicente de Paul
Zulma Urbina, Hospital San Rafael

Marcelo Ochoa Parra, Hospital Jose Carrasco Arteaga

Hesham Elsayed, Suez Canal University

Gia Tomadze, City Hospital #1

Ashok Kumar Mahapatra, All India Institute of Medical Sciences
Rajesh Bhagchandani, Apex Hospital Bhopal
Haroon Pillay, Baby Memorial Hospital
Yashbir Dewan, Christian Medical College
K V Viswanathan, Medical College Trivandrum
Venkatesh Babu, Sri Sakthi Hospital
T K Manoj, St James Hospital
Iran: Eshan Sherafat, Nemazi Hospital

Annalisa Volpi, Azienda Ospedaliera Di Parma

Masayoshi Abe, Fukuoka University Hospital

Lawal Khalid, Ahmadu Bello University Teaching Hospital
Ahmed Olugbenga Sanni, Lagos State Univ Teaching Hospital
Kehinde Oluwadiya, LAUTECH Teaching Hospital
Oluwole Olayemi Olaomi, National Hospital Abuja
Lateef Thanni, Olabisi Onabanjo University Teaching Hospital
T O Odebode, University of Ilorin Teaching Hospital

Saudi Arabia
Megahid Eldawlatly, King Khalid National Guard Hospital

Surakrant Yutthakasemsunt, Khon Kaen Regional Hospital

Kazim Mirza and Karly Robbshaw, Colchester General Hospital

welcome to new sites with ethics approval

Team from University of Maiduguri Teaching Hospital, Nigeria, with PI Abubakar Muhammad Musa, who obtained ethics approval in December.

Maiduguri team

Ian Seppelt, Nepean Hospital
Valarie Malka, Westmead Hospital

Patrick Druwé, Sint-Vincentius Hospital

Frank Baillie and Rada Petrovic, Hamilton General Hospital

Ji-yao Jiang, Renji Hospital

Zulma Urbina Contreras, Hospital San Rafael

Petr Svoboda, Research Institute for Special Surgery and Trauma

T S Vasan, Command Hospital
Venkatesh Babu, Sri Sakthi Hospital
T K Manoj, St James Hospital

Annalisa Volpi, Azienda Ospedaliera Di Parma

Jorge Loria-Castellanos, Hospital General Regional 25

Lateef Thanni, Olabisi Onabanjo University Teaching Hospital
Abubakar Muhammad Musa, University of Maiduguri Teaching Hospital
Herb Giebel, Seventh Day Adventist Hospital

Abdelazeem Eldawlatly, King Khalid University Hospital

Surakrant Yutthakasemsunt, Khon Kaen Regional Hospital

Steve Goodacre, Northern General Hospital
Peter Burdett-Smith, Royal Liverpool University Hospital
Tim Harris, The Royal London Hospital