Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial.
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 recruit...
| Published in: | Lancet Vol. 364; no. 9442; pp. 1321 - 1329 |
|---|---|
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
| Format: | clinical trial research tables/charts Journal Article |
| Published: |
Lancet
10/9/2004
|
| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=106544082&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 106544082 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01406736 LAN jtl: Lancet issn: 01406736 maglogo: N pubinfo: dt: 10/9/2004 vid: 364 iid: 9442 pid: 1297 pub: Lancet place: Philadelphia, Pennsylvania artinfo: ui: 106544082 106544082 NLM15474134 2009057025 10.1016/s0140-6736(04)17188-2 NLM15474134 106544082 ppf: 1321 ppct: 8 formats: fmt: @attributes: type: P tig: atl: Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial. aug: au: Roberts, Ian Yates, David Sandercock, Peter Farrell, Barbara Wasserberg, Jonathan Lomas, Gabrielle Cottingham, Rowland Svoboda, Petr Brayley, Nigel Mazairac, Guy Laloë, Véronique Muñoz-Sánchez, Angeles Arango, Miguel Hartzenberg, Bennie Khamis, Hussein Yutthakasemsunt, Surakrant Komolafe, Edward Olldashi, Fatos Yadav, Yadram Murillo-Cabezas, Francisco sug: subj: Head Injuries Drug Therapy Head Injuries Mortality Methylprednisolone Therapeutic Use Adolescence Adult Africa Asia Chi Square Test Clinical Trials Confidence Intervals Europe Female Glasgow Coma Scale Head Injuries Radiography Infusions, Intravenous Male Methylprednisolone Administration and Dosage Middle Age Mortality Risk Factors Placebos Questionnaires Random Assignment Severity of Injury South America Tomography, X-Ray Computed Trauma Severity Indices Funding Source Human Adolescent: 13-18 years Adult: 19-44 years Middle Aged: 45-64 years Female Male 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 20000 patients. In May, 2004, the data monitoring committee disclosed the unmasked results to the steering committee, which stopped recruitment. Methods: 10008 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. pubtype: Academic Journal doctype: clinical trial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|