TY - JOUR
T1 - Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial)
T2 - Randomised placebo-controlled trial
AU - CRASH trial collaborators
AU - Olldashi, Fatos
AU - Muzha, Itan
AU - Filipi, Nikolin
AU - Lede, Roberto
AU - Copertari, Pablo
AU - Traverso, Carolina
AU - Copertari, Alejandro
AU - Vergara, Enrique Alfredo
AU - Montenegro, Carolina
AU - De Huidobro, Roberto Ruiz
AU - Surt, Karina
AU - Cialzeta, José
AU - Lazzeri, Silvio
AU - Piñero, Gustavo
AU - Ciccioli, Fabiana
AU - Videtta, Walter
AU - Barboza, María Fernanda
AU - Svampa, Silvana
AU - Sciuto, Victor
AU - Domeniconi, Gustavo
AU - Bustamante, Marcelo
AU - Waschbusch, Maximiliano
AU - Gullo, María Paula
AU - Drago, Daniel Alberto
AU - Linares, Juan Carlos Arjona
AU - Camputaro, Luis
AU - Tróccoli, Gustavo
AU - Galimberti, Hernán
AU - Tallott, Mandy
AU - Eybner, Christian
AU - Buchinger, Walter
AU - Fitzal, Sylvia
AU - Mazairac, Guy
AU - Oleffe, Véronique
AU - Grollinger, Thierry
AU - Delvaux, Philippe
AU - Carlier, Laurent
AU - Braet, Veronique
AU - Jacques, Jean Marie
AU - De Knoop, Danielle
AU - Nasi, Luiz
AU - Choi, Humberto Kukhuyn
AU - Schmitt, Mara
AU - Gentil, André
AU - Nacul, Flavio
AU - Barrios, Pedro Bedoya
AU - Xinkang, Chen
AU - Hua, Lin Shao
AU - Tian, Huang Han
AU - Haines, Stephen
N1 - Publisher Copyright:
© 2004, Lancet Publishing Group. All rights reserved.
PY - 2004/10/9
Y1 - 2004/10/9
N2 - Background Corticosteroids have been used to treat head injuries for more than 30 years. In 1997, findings of a systematic review suggested that these drugs reduce risk of death by 1-2%. The CRASH trial—a multicentre international collaboration—aimed to confirm or refute such an effect by recruiting 20 000 patients. In May, 2004, the data monitoring committee disclosed the unmasked results to the steering committee, which stopped recruitment. Methods 10 008 adults with head injury and a Glasgow coma score (GCS) of 14 or less within 8 h of injury were randomly allocated 48 h infusion of corticosteroids (methylprednisolone) or placebo. Primary outcomes were death within 2 weeks of injury and death or disability at 6 months. Prespecified subgroup analyses were based on injury severity (GCS) at randomisation and on time from injury to randomisation. Analysis was by intention to treat. Effects on outcomes within 2 weeks of randomisation are presented in this report. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN74459797. Findings Compared with placebo, the risk of death from all causes within 2 weeks was higher in the group allocated corticosteroids (1052 [21·1%] vs 893 [17·9%] deaths; relative risk 1·18 [95% CI 1·09-1·27]; p=0·0001). The relative increase in deaths due to corticosteroids did not differ by injury severity (p=0·22) or time since injury (p=0·05). Interpretation Our results show there is no reduction in mortality with methylprednisolone in the 2 weeks after head injury. The cause of the rise in risk of death within 2 weeks is unclear.
AB - Background Corticosteroids have been used to treat head injuries for more than 30 years. In 1997, findings of a systematic review suggested that these drugs reduce risk of death by 1-2%. The CRASH trial—a multicentre international collaboration—aimed to confirm or refute such an effect by recruiting 20 000 patients. In May, 2004, the data monitoring committee disclosed the unmasked results to the steering committee, which stopped recruitment. Methods 10 008 adults with head injury and a Glasgow coma score (GCS) of 14 or less within 8 h of injury were randomly allocated 48 h infusion of corticosteroids (methylprednisolone) or placebo. Primary outcomes were death within 2 weeks of injury and death or disability at 6 months. Prespecified subgroup analyses were based on injury severity (GCS) at randomisation and on time from injury to randomisation. Analysis was by intention to treat. Effects on outcomes within 2 weeks of randomisation are presented in this report. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN74459797. Findings Compared with placebo, the risk of death from all causes within 2 weeks was higher in the group allocated corticosteroids (1052 [21·1%] vs 893 [17·9%] deaths; relative risk 1·18 [95% CI 1·09-1·27]; p=0·0001). The relative increase in deaths due to corticosteroids did not differ by injury severity (p=0·22) or time since injury (p=0·05). Interpretation Our results show there is no reduction in mortality with methylprednisolone in the 2 weeks after head injury. The cause of the rise in risk of death within 2 weeks is unclear.
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U2 - 10.1016/S0140-6736(04)17188-2
DO - 10.1016/S0140-6736(04)17188-2
M3 - Article
C2 - 15474134
AN - SCOPUS:5044223264
SN - 0140-6736
VL - 364
SP - 1321
EP - 1328
JO - The Lancet
JF - The Lancet
IS - 9442
ER -