Issue 8 Winter 2007

CRASH2 logo

In December 2006, the Health Technology Assessment (HTA) programme, which is part of the UK National Health Service Research & Development Programme, announced that it would fund the international CRASH-2 trial until its completion in 2010. The Clinical Trials Board which assessed the CRASH-2 application as part of its highly competitive peer reviewed funding round, congratulated the trial collaborators on their success. The HTA funding will enable the trial to expand to more hospitals and more countries ensuring that our recruitment target of 20,000 patients is achieved. Already, applications from hospitals to join the CRASH-2 trial have reached a new peak with many new hospitals beginning to recruit in January and February and hundreds more waiting to get started.

HTA logo
More good news for the CRASH-2 trial, at least for collaborating hospitals in the UK, was the December 2006 amendment to the UK's Medicines for Human Use (Clinical Trials) Regulations. The amendment allows unconscious patients in emergency situations to be enrolled in clinical trials without prior consent provided that this has been approved by the appropriate ethics committee – as is the case in the CRASH-2 trial. The amendment had been anxiously awaited by emergency care researchers in the UK since the regulations were changed in 2004 making it much harder to enrol seriously injured patients in emergency situations. Further details of the amendment are available in a BMJ editorial by Haleema Shakur.

Audio screenimage

You can now listen to audio broadcasts of talks on clinical trial related subjects by eminent speakers on the CRASH2 website. On the left hand column click on AUDIO BROADCASTS and then click on the icon next to each speaker. You can also download some talks as PowerPoint presentations and pdf-files.

Current contributors include Sir Iain Chalmers, Editor of the James Lind Library, UK, and Professor Salim Yusuf, Professor of Medicine at McMaster University, Hamilton Health Sciences, Canada.


trial team is growing

Kate James

I started working with the Trials Co-ordinating Centre in December 2006. Prior to this I have gained a degree in Biology and have experience working in a co-ordination unit as a specialist administrator. However, I am excited to be involved in an international clinical trial.
Kate James, Trials assistant
Recruitment graph
Patient recruitment approaching 4,000


Q. Why do I have to use treatment packs in sequence order?
A. For centres using ‘next pack’ randomisation, a random sequence has been used to set the allocation order of the eight treatment packs within each box. There is also a balance of active and placebo treatment packs within each box to ensure that treatment group numbers are evenly balanced at the end of each box. Using packs out of sequence or packs from more than one box at a time compromises the balance. The integrity of the CRASH-2 trial results will be partly judged on the evidence for whether random allocation of treatment assignment was successfully achieved for every patient enrolled.
For these reasons, it is critical that collaborators use treatment packs strictly in the correct sequence.

Q. What if I accidentally start with the last pack in a box?
A. In that case please use the remaining packs in reverse order.

Q. I have accidentally skipped a pack – what should I do?
A. Use this pack next and then return to the correct sequence order.

Q. The next pack was found to be damaged when opened or cannot be found?
A. Use the next available pack for randomisation, then destroy any damaged packs. Always remember to report damaged and lost treatment packs to the Co-ordinating Centre as soon as possible, so that they can be removed from your drug stock in the database.

first patient
Congratulations to the teams who have started randomisation:

  • David Mountain and Lisa Gray, Sir Charles Gairdner Hospital, Australia
  • Andres Rubiano, Hospital Universitario de Neiva, Colombia
  • Virsinghai Hathila, Sir Sayajirao General Hospital & Medical College Baroda, India
  • Giovanna Perone, Spedali Civili di Brescia, Italy
  • Baharudin Bin Abdullah, Hospital University Science, Malaysia
  • Andrew Dongo, Irrua Specialist Teaching Hospital, Nigeria
  • Ivan Ng Hua Bak, National Neuroscience Institute, Singapore
  • William Townend, Hull Royal Infirmary, United Kingdom

new ethics approvals
We welcome new sites – 141 sites in 34 countries now have ethics approval for CRASH2.
In addition we are making great progress in expanding in China with several new centres preparing to take part. The application process has also started in Russia – watch this space!


  • Silvana Svampa, Hospital Castro Rendon
  • Jorge Omar Balbi, Hospital Regional Rio Grande


  • Jorge Augusto Herrera Chaparro, Hospital Universitario San Jose De Popayan


  • David Suresh, Christian Medical College Hospital, Vellore
  • Sharad Vyas, Civil Hospital, Gandhinagar
  • Sojan Ipe and Bobby Jose, MOSC Medical College Hospital
  • Gordon Rangad, Nazareth Hospital
  • Pankaj Patel, Sheth VS General Hospital and NHL Municipal College
  • Virsinghai Hathila, Sir Sayajirao General Hospital & Medical College Baroda


  • Farhad Bal'afif, Saiful Anwar General Hospital


  • Michael Durodola, Baptist Medical Centre
  • Andrew Dongo, Irrua Specialist Teaching Hospital
  • Andrew Akinkuolie, Wesley Guild Hospital


  • Juan de Dios Velez Temoche, Hospital La Caleta
  • Marco Gonzales Portillo, Hospital Nacional Dos De Mayo
Background image: Christian Medical College, Vellore, India
special congratulations

100 randomised patients

Surakrant Yutthakasemsunt
Khon Kaen Regional Hospital, Thailand

Oluwole Olayemi Olaomi
National Hospital Abuja, Nigeria

Moch Dwikoryanto
Soebandi Hospital Jember, Indonesia

50 randomised patients

Wu Hoong Chhang
North Bengal Neuro Research Centre, India

Edward Komolafe
Obafemi Awolowo University Teaching Hospitals

Fatos Olldashi
National Trauma Centre Hospital, Albania


We invite applications from intelligent, industrious and imaginative clinicians with experience of trauma care in low and middle income countries to join an ambitious programme of trauma care research. Watch out for more details in the trial website or at

crash 2 round the world
Team at San Gregorio
Clínica De Especilidades Medicas “San Gregorio“
, with Rubén Camacho as PI have recently received their trial materials and hope to start randomisation very soon. Pablo Perel went to visit Ecuador.
In January Tamar Gogichaishvili, our Georgia National Co-ordinator, presented the trial in the 2nd International Neurosurgical Winter Meeting in Zermatt, Switzerland, and received a certificate for an “outstanding presentation”.
Many congratulations to Carolina Goméz Builes who looks after the data in several Colombian hospitals, for her recent marriage to Fede.