Lancet
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Randomized Controlled Trial Multicenter Study Clinical Trial
Recombinant bactericidal/permeability-increasing protein (rBPI21) as adjunctive treatment for children with severe meningococcal sepsis: a randomised trial. rBPI21 Meningococcal Sepsis Study Group.
Endotoxin is a primary trigger of the inflammatory processes that lead to shock, multiorgan failure, and purpura fulminans in meningococcal sepsis. Bactericidal/permeability-increasing protein (BPI) is a natural protein, stored within the neutrophil granules, that binds to and neutralises the effects of endotoxin in vitro, in laboratory animals, and in humans. To establish whether a recombinant 21-kDa modified fragment of human BPI (rBPI21), containing the active antimicrobial and endotoxin-neutralising moiety, would decrease death and long-term disability from meningococcal sepsis, we did a randomised, double-blind, placebo-controlled trial of rBPI21 in children with severe meningococcal sepsis. ⋯ Because most deaths occurred in the interval between identification of patients and study drug administration, the mortality rate in the placebo group was substantially lower than predicted. The trial was therefore underpowered to detect significant differences in mortality. However, patients receiving rBPI21 had a trend towards improved outcome in all primary outcome variables. Given the excellent severity match between placebo and rBPI21 groups at study entry, the results overall indicate that rBPI21 is beneficial in decreasing complications of meningococcal disease.
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Randomized Controlled Trial Comparative Study Clinical Trial
Alternative strategies for stroke care: a prospective randomised controlled trial.
Organised specialist care for stroke improves outcome, but the merits of different methods of organisation are in doubt. This study compares the efficacy of stroke unit with stroke team or domiciliary care. ⋯ Stroke units are more effective than a specialist stroke team or specialist domiciliary care in reducing mortality, institutionalisation, and dependence after stroke.
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The decrease in mortality and improved outcome for patients with severe traumatic brain injury over the past 25 years can be attributed to the approach of "squeezing oxygenated blood through a swollen brain". Quantification of cerebral perfusion by monitoring of intracranial pressure and treatment of cerebral hypoperfusion decrease secondary injury. Before the patient reaches hospital, an organised trauma system that allows rapid resuscitation and transport directly to an experienced trauma centre significantly lowers mortality and morbidity. Only the education of medical personnel and the institution of trauma hospital systems can achieve further improvements in outcome for patients with traumatic brain injuries.