CRASH TRIAL ÎN ROMÂNIA

December 1, 2001

Laura Balica *, Sklerniacof M. **, Oprita B *, Rodica Ciolacu *, Stanciu D. *, Laura Bandut *, Laura Cotoros *, Anca Barliga *, Andreea Mitescu *, Pandrea C. *, Vasilescu L. ***
* medici specialiști Medicină de Urgență, Departamentul de Gardă, Spitalul Clinic de Urgență București
** medic specialist neurochirurg, Secția Neurochirurgie, Spitalul Clinic de Urgență București
*** medic primar Medicină de Urgență, Departamentul de Gardă, Spitalul Clinic de Urgență București

Abstract

The propouse of this review is not to make a propaganda of a trial or/and a substance. We try to inform roumanian medical comunitte about “CRASH trial”(CRASH=Corticosteroid Randomisation After Significant Head Injury), it’s development in Romania and actual stage of the study.Because all over the world don’t exist a clear and obivous atitude in administration of corticosteroids in head trauma, a lot of famous british professors initiate a large multicentric tial to study this effects.This is a simple large placebo vs. methylpredni­ solone trial, among adults (age>16 years) with head injury and impaired consciousness (GCS£14), within 8 hours from injury, of the effects of 48 hour infusion of corticosteroids on death and neurological disability. The trial begaining in Romania in Emergency Departament of Bucharest Emergency Clinical Hospital on 12.03.2001 at 5 a.m. when first pacient was randomised. Until now (08.11.2001) the emergency physicians randomised 47 paciens with head trauma from almost 2000 who are enrolled all over the world.The procedure of randomised is simple: any pacient who respect former criteria is eligible, extra tests is not necessary, the trial not involve extra work (an Entry Form is sent by fax or e-mail when the pacient is enrolled, another form will be complete at discharge, death in hospital, or two weeks from injury, whichever occurs first).The whole materials (including substaces) are ensured by CRASH Co-ordinating Centre from London.The propouse of the study is to randomised 20 000 pacients until 2005 and if corticosteroids reduce the risk of death by just 2% and reduced the risk of permanent neurological disability by a similar amount this could be worthwhile.For these reasons (especially for rice traumatic pathology) we consider that many other romanian hospital could be take part on this trial. For more detalils you can contact our hospital or visit website: www.crash.ucl.ac.uk (soon in roumanian).