Journal of neurotrauma
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Journal of neurotrauma · Aug 2009
Randomized Controlled TrialProstacyclin treatment in severe traumatic brain injury: a microdialysis and outcome study.
Prostacyclin (PGI(2)) is a potent vasodilator, inhibitor of leukocyte adhesion, and platelet aggregation. In trauma the balance between PGI(2) and thromboxane A(2) (TXA(2)) is shifted towards TXA(2). Externally provided PGI(2) would, from a theoretical and experimental point of view, improve the microcirculation in injured brain tissue. This study is a prospective consecutive double-blinded randomized study on the effect of PGI(2) versus placebo in severe traumatic brain injury (sTBI). All patients with sTBI were eligible. ⋯ verified sTBI, Glasgow Coma Score (GCS) at intubation and sedation of
or=10 mm Hg, and arrival within 24 h of trauma. All subjects received an intracranial pressure (ICP) measuring device, bilateral intracerebral microdialysis catheters, and a microdialysis catheter in the abdominal subcutaneous adipose tissue. Subjects were treated according to an ICP-targeted therapy based on the Lund concept. 48 patients (mean age of 35.5 years and a median GCS of 6 [3-8]) were included. We found no significant effect of prostacyclin (epoprostenol, Flolan) on either the lactate-pyruvate ratio (L/P) at 24 h or the brain glucose levels. There was no significant difference in clinical outcome between the two groups. The median Glasgow Outcome Score (GOS) at 3 months was 4, and mortality was 12.5%. The favorable outcome (GOS 4-5) was 52%. The initial L/P did not prognosticate for outcome. Thus our results indicate that there is no effect of PGI(2) at a dose of 0.5 ng/kg/min on brain L/P, brain glucose levels, or outcome at 3 months. -
Journal of neurotrauma · Mar 2009
Randomized Controlled Trial Multicenter StudyMulticenter trial of early hypothermia in severe brain injury.
The North American Brain Injury Study: Hypothermia IIR (NABIS:H IIR) is a randomized clinical trial designed to enroll 240 patients with severe brain injury between the ages of 16 and 45 years. The primary outcome measure is the dichotomized Glasgow Outcome Scale (GOS) at 6 months after injury. The study has the power to detect a 17.5% absolute difference in the percentage of patients with a good outcome with a power of 80%. ⋯ Patients enrolled in the normothermia arm receive standard management at normothermia. As of December 2007, 74 patients had been randomized into phase II of the protocol. Patients in the hypothermia arm reached 35 degrees C in 2.7 +/- 1.1 (SD) h after injury and reached 33 degrees C at 4.4 +/- 1.5 h after injury.
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Journal of neurotrauma · Aug 2008
Randomized Controlled TrialEffect of rosuvastatin on amnesia and disorientation after traumatic brain injury (NCT003229758).
Amnesia is a common sequela following traumatic brain injury (TBI), for which there is no current treatment. Pleiotropic effects of statins have demonstrated faster recovery of spatial memory after TBI in animals. We conducted a double-blind randomized clinical trial add-on of patients with TBI (16-50 years of age), with Glasgow Coma Scale (GCS) scores of 9-13, and intracranial lesions as demonstrated by computed tomography (CT) scan. ⋯ IL-6 values at day 3 were increased in the RVS group (p = 0.04). No difference was detected in disability at 3 months. While statins may reduce amnesia time after TBI, possibly by immunomodulation, further trials are needed in order to confirm this positive association.
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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.