Articles: brain-injuries.
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Randomized Controlled Trial Multicenter Study
Hypothermia pediatric head injury trial: the value of a pretrial clinical evaluation phase.
The utility of a pretrial clinical evaluation or run-in phase prior to conducting trials of complex interventions such as hypothermia therapy following severe traumatic brain injury in children and adolescents has not been established. ⋯ The pretrial clinical evaluation phase was useful to ensure compliance with complex hypothermia therapy and consensus-based clinical management guidelines of care successfully implemented across 17 of 18 centers. This study maneuver allowed us to complete a subsequent RCT in 225 children following severe traumatic brain injury.
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Pediatr Crit Care Me · Jan 2006
Randomized Controlled TrialTemporal nutritional and inflammatory changes in children with severe head injury fed a regular or an immune-enhancing diet: A randomized, controlled trial.
To analyze the effect of an immune enhancing (IE) diet on infection and metabolic indices in children with severe head injury fed either an IE or a regular formula. ⋯ Although immunonutrition might decrease interleukin-8 and gastric colonization in children with severe head injury, it might not be associated with additional advantage over the one demonstrated by regular early enteral nutrition.
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Randomized Controlled Trial
The use of controlled mild hypothermia and immune system status in patients with severe brain injury.
Severe brain injuries pose one of the most important problems on our health care because of their high morbidity and mortality. ⋯ Intensive treatment of intracranial hypertension fundamentally affects results of our treatment (Glasgow Outcome Score). The application of controlled mild hypothermia doesn't escalate the occurrence of extra cranial inflammatory complications after severe brain injury (Tab. 2, Fig. 11, Ref. 15).
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy and safety of dexanabinol in severe traumatic brain injury: results of a phase III randomised, placebo-controlled, clinical trial.
Traumatic brain injury is a major cause of death and disability. We sought to assess the safety and efficacy of dexanabinol, a synthetic cannabinoid analogue devoid of psychotropic activity, in severe traumatic brain injury. ⋯ Dexanabinol is safe, but is not efficacious in the treatment of traumatic brain injury.
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Journal of neurotrauma · Jan 2006
Randomized Controlled TrialCyclosporin A disposition following acute traumatic brain injury.
Although the precise mechanism of action remains to be defined, Cyclosporin A (CsA) has demonstrated potential for neuroprotection in animal models. Predictive dosing strategies for CsA in acute traumatic brain injured (TBI) patients must account for the influence of the acute phase response on drug disposition. To characterize CsA pharmacokinetic parameters early following acute TBI, serial blood samples from patients enrolled into a Phase II dose-escalation trial were analyzed. ⋯ Whole blood clearance, steady state volume of distribution, and beta half-life were independent of dose and higher than published reports from other populations: 0.420 L/h/kg, 5.91 L/kg, and 17.3 h, respectively. These data show patients with acute severe TBI demonstrate a more rapid clearance and a larger distribution volume of CsA. Pharmacokinetic parameters derived from this study will guide dosing strategies for future prospective clinical trials evaluating CsA therapy following acute TBI.