Issue 4 NEWSLETTER July 1999
Over 100 patients!

Overseas interest in the trial has grown considerably in the past month…
Stefan Trenkler in Slovakia and Jürgen Piek in Germany now have Ethics Committee approval and are due to start recruitment soon. New collaborators in Spain, Sweden and Italy are applying for Ethics Committee approval. Even further afield centres in Japan, China and Sri-Lanka are keen to get involved. In the UK, Nigel Brayleys’ team at Colchester General Hospital have started recruitment with gusto, pushing numbers of randomised patients up. Birmingham Heartlands Hospital, Bury General and the Royal Liverpool University Hospital now have treatment packs on site and plan to start recruitment in August. New collaborating centres include North Staffordshire Hospital and The Countess of Chester Hospital.
 
Facts and figures: below are some details about the patients randomised to date.
In keeping with the inclusion criteria, there is a wide range of head injury severity included in the trial: 22% of patients had severe head injury, 40% had moderate head injury and 37% had mild head injury. This is an important strength. If a wide range of patients are randomised then it may be possible for a large trial such as this one to help determine which particular types of patient are most likely to benefit from treatment.
GCS
Number of
patients
%
3 - 8
23
22.5
9 - 12
41
40.2
13 - 14
38
37.3
Total
102
  

As regards timing, results from animal studies suggest that early administration of corticosteroid is important for maximal effect. Timing of corticosteroid administration has also been shown to be important in acute spinal cord injury. The fact that 79% of patients in the CRASH trial were treated within three hours from injury is very encouraging.		  
Sex
Number of
patients
Male
81
Female
21
Age
Number of
patients
16 - 24
29
24 - 35
22
36 +
51
Total
102
THE MILLENIUM: Several collaborators have asked ‘what’s happening with recruitment over the millenium?’ The answer is keep going! Plans are currently being made with CTSU to ensure the randomisation procedure works smoothly and that all the usual facilities (unblinding etc.) are in place. We will provide more specific information nearer to the time in a subsequent newsletter.

CRASH Trial Co-ordinator, Nin Ritchie

CRASH Co-ordinating Centre, FREEPOST LON 14211, LONDON WC1N 1BR

Tel: + 44 (0)20 7299 4684 Fax: + 44 (0)20 7299 4663 email: CRASH@lshtm.ac.uk

Back to Home Page