Articles: traumatic-brain-injuries.
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Randomized Controlled Trial Multicenter Study
Plasma Potassium Concentration on Admission Correlates with Neurological Outcome in Traumatic Brain Injury Patients Treated with Targeted Temperature Management: a Post Hoc Analyses of a Multicenter Randomized Controlled Trial.
Recent studies have focused on the association between plasma electrolytes, particularly potassium level and neurologic outcomes in patients with traumatic brain injury (TBI). We hypothesized that potassium level on admission is an indicator for initiation of targeted temperature management in patients with severe TBI. ⋯ The initial potassium level may be an indicator in determining appropriate targeted temperature management for patients with TBI. Fever control may be considered instead of MTH for normokalemia patients with TBI on admission.
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Journal of neurosurgery · Sep 2016
Randomized Controlled TrialSerum biomarkers as predictors of long-term outcome in severe traumatic brain injury: analysis from a randomized placebo-controlled Phase II clinical trial.
OBJECTIVE There has been increased interest in the potential importance of biochemical parameters as predictors of outcome in severe traumatic brain injury (sTBI). METHODS Of 107 patients with sTBI (age 18-65 years with a Glasgow Coma Scale score of 4-8 presenting within 8 hours after injury) who were randomized for a placebo-controlled Phase II trial of progesterone with or without hypothermia, the authors serially analyzed serum biomarkers (S100-B, glial fibrillary acidic protein [GFAP], neuron-specific enolase [NSE], tumor necrosis factor-α, interleukin-6 [IL-6], estrogen [Eg], and progesterone [Pg]). This analysis was performed using the sandwich enzyme-linked immunosorbent assay technique at admission and 7 days later for 86 patients, irrespective of assigned group. ⋯ CONCLUSIONS Serial Pg, GFAP, and IL-6 monitoring could aid in prognosticating outcomes in patients with acute sTBI. A cause and effect relationship or a mere association of these biomarkers to outcome needs to be further studied for better understanding of the pathophysiology of sTBI and for choosing potential therapeutic targets. Clinical trial registration no.: CTRI/2009/091/000893 ( http://www.ctri.nic.in ).
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J Head Trauma Rehabil · Sep 2016
Randomized Controlled TrialFeasibility of a Cognitive Behavioral Intervention to Manage Fatigue in Individuals With Traumatic Brain Injury: A Pilot Study.
To evaluate the feasibility of conducting a randomized clinical trial of an Internet-based manualized intervention to teach individuals with traumatic brain injury to manage their fatigue. ⋯ Findings from the study suggest that the MAX intervention is feasible to administer to individuals with post-traumatic brain injury fatigue.
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Journal of neurotrauma · Aug 2016
Randomized Controlled Trial Multicenter StudyExternal validation of the IMPACT prognostic models for traumatic brain injury on the SyNAPSe trial.
Prediction models for patients with traumatic brain injury (TBI) are important for multiple reasons, including case-mix adjustment, trial design, and benchmarking for quality-of-care evaluation. Models should be generalizable and therefore require regular external validation. We aimed to validate the International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) prognostic models for moderate and severe TBI in a recent randomized controlled trial. ⋯ This pattern of miscalibration was consistent across all three models. In a contemporary trial setting, the IMPACT models have reasonable discrimination if enrollment restrictions apply. Observed changes in outcome distribution necessitate updating of previously developed prognostic models.
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Undersea Hyperbar M · Aug 2016
Randomized Controlled Trial Multicenter StudyExecutive summary: The Brain Injury and Mechanism of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury (mTBI) (BIMA) Study.
The Brain Injury and Mechanism of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury (mTBI) (BIMA) study, sponsored by the Department of Defense and held under an investigational new drug application by the Office of the Army Surgeon General, is one of the largest and most complex clinical trials of hyperbaric oxygen (HBO₂) for post-concussive symptoms (PCS) in U. S. military service members.