Newsletter
Issue 3 Autumn 2005

There is massive clinician interest in the CRASH-2 trial: At the time of writing over 300 hospitals from 30 countries have expressed a willingness to take part. Of these more than 80 have already obtained ethics committee approval.

Collaborators are getting ethics approval in record time: The interval between the Co-ordinating Centre sending out an ethics pack and ethics committee approval was 20 weeks in CRASH-1 but in CRASH-2 is down to 13 weeks. This shows clearly the advantages of having a network of experienced collaborators.

Trial recruitment is well ahead of that in the CRASH-1 trial: For the same interval into the trial we have recruited almost twice as many patients in the CRASH-2 trial.

The trial treatment is being given very early: Over two thirds of patients included so far were recruited within 3 hours of the injury. Most of the remaining patients were recruited between 3 and 5 hours following the injury with only a small proportion recruited between 5 and 8 hours following the injury. These data confirm that the treatment can be administered in the emergency setting within a short time of the injury. Early treatment is essential – please keep up the good work.

The characteristics of patients are as we would expect: 86% of trial participants are males. The mean age of trial participants is 31 years, the median age is 29 years and the mode is 20 years. About half of the patients had blunt trauma, the rest having either penetrating trauma alone or a mixture of blunt and penetrating trauma.
The observed event rates are as we anticipated: The primary outcome measure is death in hospital within four weeks of injury. For our sample size calculations we estimated that about 20% of patients would die as a result of their injuries. Based on the first 200 patients randomised our estimates appear to be accurate. 22% of patients died from their injuries, the two most common causes of death being excessive blood loss and multi-organ failure. About half of the patients received a blood transfusion (a secondary outcome measure). Among those who survived to leave hospital, most (80%) had made a good recovery with only 8% of patients dependent on others for day to day activities.

In other words… we are on track to deliver a very important trial: If tranexamic acid reduced death and transfusion requirement after trauma this would be a major medical discovery. Only a large scale trial can answer this question. So far we are right on track. The challenge now is to continue to increase the number of participating hospitals and to increase the rate of recruitment at each.

EVERY PATIENT COUNTS!

HUSSEIN KHAMIS WRITES ABOUT THE EARLY EXPERIENCE OF CRASH2 IN EGYPT:
Our first randomised patient in Egypt for CRASH2 was on 17 July 2005. This was preceded by a long phase of preparation to set up the stage for the study. The preparation phase is indispensable to the smooth running of the study afterwards. There has been an ever growing enthusiasm among our team. Now, it is the time for self auditing!! This should be performed periodically to ensure the quality of our work and correct pitfalls that will unavoidably arise as the study gets to more depth. Joining an international team in a study like this, is an unforgettable experience.

Mario Izurieta says: Crash2 trial is an learning experience. The majority of patients that we receive for the trial have penetrating injuries. Blunt abdominal injury is more challenging because of the results of the first assessment at admission. Some patients arrive critically ill, bleeding and showing systolic blood pressure of about 60 mmHg, so we have to work hard and co-ordinate the efforts to save their lives. The team in my hospital are developing a great enthusiasm to achieve our goal – to randomize as many patients as we can. We invite everyone to join CRASH2, we know we will make a difference!
"Live as if you were to die tomorrow. Learn as if you were to live forever."(Mahatma Gandhi)

new collaborators

NEW CENTRES WITH ETHICS APPROVAL CONTINUE TO FLOOD IN. A TOTAL OF 82 HOSPITALS INCLUDE THE FOLLOWING NEWCOMERS:

ALBANIA: Arben Banushi, Spitali Civil Durres

ARGENTINA: Fernanda Barboza, Hospital Dr Ramón Carrillo

COLOMBIA: Arturo Arias, Fundación Clínica Universitaria Santa Catalina; Carlos H Morales Uribe, Hospital Universitario San Vicente de Paul; Luz Elena Flores Rueda and Argemino Gallego Ossa, Hospital General de Medellin; Wilson Gualteros, Hospital Universitario San Jorge; Carlos Rebolledo, Clínica General del Norte

CUBA: Marcos Iraloa Ferrer, Hospital Universitario "Dr Gustavo Aldereguia Lima"; Mario Dominguez Perera, Hospital Universitario "Arnaldo Milián Castro"

GEORGIA: Gia Tomadze, City Hospital #1

INDIA: P V Ramana, Care Hospital; K V Viswanathan, Medical College, Trivandrum; N K Venkataramana, Manipal Hospital

IRAN: Ehsan Sherafat Kazemzadeh, Nemazi Hospital

JAPAN: Abe Masayoshi, Fukuoka University Hospital

MALAYSIA: Baharudin Bin Abdullah, Hospital University Science Malaysia; April Roslani, University of Malaya Medical Centre

MEXICO:Felipe Rendon Elias, Hospital Universitario "Dr Jose E Gonzalez"

NIGERIA: Ahmed Olugbenga Sanni, Lagos State University Teaching Hospital; Charles Adeyinka Adisa, Abia State University Teaching Hospital; Lawal Khalid, Ahmadu Bello University Teaching Hospital; Oluwole Olayemi Olaomi, Abuja National Hospital; T O Odebode, University of Ilorin Teaching Hospital

POLAND: Adam Mikstacki, Poznan Regional Hospital; Wojciech Gorecki, Krakow University Children's Hospital

SAUDI ARABIA: Walid Alyafi and Megahid Eldawlatly, King Khalid National Guard Hospital

SINGAPORE: Ivan Nq Hua Bak, National Neuroscience Institute

VENEZUELA: Gamal Hamdan Suleiman, Instituto Autonomo Hospital Universitario de los Andes

UK: Fiona MacMillan, Furness General Hospital; Kazim Mirza, Colchester General Hospital; Bill Bailey, Chesterfield Royal Hospital; Jeremy Henning, James Cook University Hospital; Fiona Lecky, Hope Hospital; Suzanne Brady, Worthing Hospital

The teams in all these hospitals have managed to get over the first hurdle of identifying their first eligible patient. Be brave – just do it! Randomisation will get easier after the first one.

• Hussein Khamis, Mataria Teaching Hospital, Egypt – TOP RECRUITER!!!
• Juan Diego Ciro Quintero, Clínica las Americas, Colombia
• Hernando Delgado Chaves, Hospital Civil De Ipiales, Colombia
• Jorge Mejia Mantilla, Fundación Clínica Valle del Lili, Colombia
• Mamdouh Alamin, Aswan Teaching Hospital, Egypt
• Tamar Gogichaisvili, Tbilisi State Medical University, Central Clinic, Georgia
• R R Ravi, Medical Trust Hospital Kochi,India
• Y R Yadav, NSCB Medical College, India
• Wu Hoong Chhang, North Bengal Neuro Research Centre, India
• Sanjay Gupta, Sri Sai Hospital, India
• Nyoman Golden, Sanglah General Hospital, Indonesia
• Moch Dwikoryanto, Soebandi Hospital Jember, Indonesia
• Bello Balas, Usmanu Danfodiyo University Teaching Hospital, Nigeria
• Jay Banerjee, Leicester Royal Infirmary, UK

CRASH2 training session in Spitali Civil Durres, Albania