Issue 2 NEWSLETTER May 1999
First month over 30 randomised patients
Within the first month of recruitment the number of patients randomised is more than in TWO published randomised trials of steroids in head injury.

Recruitment is excellent with the numbers entered rising rapidly. Most (66%) patients were treated within 4 hours of injury. Congratulations to all. 

The following hospitals have now randomised patients:
  • Cheltenham General Hospital
  • Eastbourne District General Hospital 
  • Hope Hospital, Manchester 
  • Queen Elizabeth Hospital, Gateshead 
  • Queen Elizabeth and Queen Mother, Kent 
  • Research Institute for Surgery and Trauma, Czech Rep 
  • Royal Bolton Hospital
When is unblinding necessary? A recent example in the CRASH trial. 

Patient X was admitted to a collaborating hospital with a head injury (GCS 10) following an assault with a scaffolding pole and was immediately randomised into the CRASH trial. The one-hour loading infusion was given in the emergency department and the first maintenance infusion was started. However, soon afterwards the patient was found to have spinal cord injury with a burst fracture at T7. In consultation with neurosurgical colleagues, at the regional neurosurgical unit the patient was being transferred to, it was decided that the patient should be started on high dose methylprednisolone treatment for the spinal cord injury. Before this could be given it was important to find out whether the patient had already received a loading dose of methylprednisolone in the CRASH Trial. The allocated treatment was therefore unblinded by calling the 24 hour randomisation service.

Notes on unblinding:

In general there should be no need to unblind the allocated treatment. If a contra-indication to corticosteroids develops after randomisation the trial treatment should simply be stopped. However, this situation was one in which clinical management depended importantly upon knowledge of whether the patient received corticosteroid or placebo and thus it was completely appropriate to unblind. 
 

Benvenuta Marina!

Marina de Leo is now working alongside Stefano Ricci, in Italy. The first Italian collaborating centres should start randomising in June. 

CRASH Trial advice - 24 hours a day

If you have any problems or questions about the CRASH Trial, a member of the CRASH team is on call and can be contacted by calling the 24-hour FREEPHONE randomisation service (0800 585 323).

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

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