Journal of neurotrauma
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Journal of neurotrauma · Nov 2007
Randomized Controlled TrialMultiplex assessment of cytokine and chemokine levels in cerebrospinal fluid following severe pediatric traumatic brain injury: effects of moderate hypothermia.
This study performed a comprehensive analysis of cerebrospinal fluid (CSF) cytokine levels after severe traumatic brain injury (TBI) in children using a multiplex bead array assay and to evaluate the effects of moderate hypothermia on cytokine levels. To this end, samples were collected during two prospective randomized controlled trials of therapeutic moderate hypothermia in pediatric TBI. Thirty-six children with severe TBI (Glasgow Coma Scale [GCS] score of
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Journal of neurotrauma · Sep 2007
Randomized Controlled TrialReliability of a telephone-based Glasgow Outcome Scale assessment using a structured interview in a heterogenous population of patients and examiners.
A reliable telephone-based Glasgow Outcome Scale (GOS) assessment would be advantageous to both patients and investigators. Using a previously published structured GOS interview and scoring system, the aim of this study was to assess the reliability of telephone-based GOS scores compared to those obtained face-to-face in a heterogenous population of patients and examiners. Sixty-six patients hospitalized for a variety of acute neurological injuries underwent two GOS interviews approximately 90 days after injury. ⋯ Patient-, examiner-, and interview-related characteristics had no significant associations with GOS concordance, although patient sex had a significant association with discrepant responses to one specific question (work at previous capacity). When used by multiple examiners to assess patients with diverse neurological conditions, use of a structured GOS examination does not guarantee a reliable telephone-based GOS score. Determination of whether patient sex influences the validity of the structured face-to-face GOS interview is worthy of future study.
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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.
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Journal of neurotrauma · Dec 2005
Randomized Controlled Trial Multicenter StudyA single dose, three-arm, placebo-controlled, phase I study of the bradykinin B2 receptor antagonist Anatibant (LF16-0687Ms) in patients with severe traumatic brain injury.
Traumatic brain injury (TBI) mortality and morbidity remains a public health challenge. Because experimental studies support an important role of bradykinin (BK) in the neurological deterioration that follows TBI, a double-blind, randomized, placebo-controlled study of Anatibant (LF16- 0687Ms), a selective and potent antagonist of the BK B(2) receptor, was conducted in severe (Glasgow Coma Scale [GCS] < 8) TBI patients (n = 25) at six sites in the United States. At 8-12 h after injury (9.9 +/- 2.8 h), patients received a single subcutaneous injection of Anatibant (3.75 mg or 22.5 mg, n = 10 each) or placebo (n = 5). ⋯ Anatibant, administered as single subcutaneous injections of 3.75 g and 22.5 mg, was well tolerated in severe TBI patients with no unexpected clinical adverse events or biological abnormalities observed. Interestingly, plasma and CSF levels of BK1-5 were significantly and markedly increased after trauma (e.g., 34,700 +/- 35,300 fmol/mL in plasma vs. 34.9 +/- 5.6 fmol/mL previously reported for normal volunteers), supporting the use of Anatibant as a treatment of secondary brain damage. To address this issue, a dose-response trial that would investigate the effects of Anatibant on the incidence of raised ICP and on functional outcome in severe TBI patients is needed.
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Journal of neurotrauma · Nov 2005
Randomized Controlled TrialHead position and impact direction in whiplash injuries: associations with MRI-verified lesions of ligaments and membranes in the upper cervical spine.
In the present study, we compared magnetic resonance imaging (MRI) findings of soft tissue structures in the upper cervical spine between whiplash-associated disorder (WAD) patients and population-based control persons, and examined whether MRI-verified abnormalities in WAD patients were related to accident-related factors hypothesized to be of importance for severity of injury. A total of 92 whiplash patients and 30 control persons, randomly drawn, were included. Information on the accident-related factors (i.e., head position and impact direction) was obtained by a questionnaire that was answered within 1 week after the accident. ⋯ Whiplash patients who had been sitting with their head/neck turned to one side at the moment of collision more often had high-grade lesions of the alar and transverse ligaments (p < 0.001, p = 0.040, respectively). Severe injuries to the transverse ligament and the posterior atlanto-occipital membrane were more common in front than in rear end collisions (p < 0.001, p = 0.001, respectively). In conclusion, the difference in MRI-verified lesions between WAD patients and control persons, and in particular the association with head position and impact direction at time of accident, indicate that these lesions are caused by the whiplash trauma.