Articles: brain-injuries.
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Pediatr Crit Care Me · Jan 2012
Randomized Controlled Trial Multicenter StudyIntracranial pressure and cerebral perfusion pressure responses to head elevation changes in pediatric traumatic brain injury.
To determine the effect of and dynamic interaction between head elevation on intracranial pressure and cerebral perfusion pressure in severe pediatric traumatic head injury. ⋯ In severe pediatric traumatic brain injury, the relationship between change in head of the bed and change in intracranial pressure was negative and linear. The lowest intracranial pressure was usually, but not always, achieved at highest head-of-the-bed angles. The effect size of a head-of-the-bed angle change depended, in part, on the subject's height. In contrast, cerebral perfusion pressure was mostly unaffected by head-of-the-bed changes.
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Randomized Controlled Trial Multicenter Study
CRASH-3 - tranexamic acid for the treatment of significant traumatic brain injury: study protocol for an international randomized, double-blind, placebo-controlled trial.
Worldwide, over 10 million people are killed or hospitalized because of traumatic brain injury each year. About 90% of deaths occur in low- and middle-income countries. The condition mostly affects young adults, and many experience long lasting or permanent disability. The social and economic burden is considerable. Tranexamic acid (TXA) is commonly given to surgical patients to reduce bleeding and the need for blood transfusion. It has been shown to reduce the number of patients receiving a blood transfusion by about a third, reduces the volume of blood transfused by about one unit, and halves the need for further surgery to control bleeding in elective surgical patients. ⋯ The CRASH-3 trial is an international, multicenter, pragmatic, randomized, double-blind, placebo-controlled trial to quantify the effects of the early administration of TXA on death and disability in patients with traumatic brain injury. Ten thousand adult patients who fulfil the eligibility criteria will be randomized to receive TXA or placebo. Adults with traumatic brain injury, who are within 8 h of injury and have any intracranial bleeding on computerized tomography (CT scan) or Glasgow Coma Score (GCS) of 12 or less can be included if the responsible doctor is substantially uncertain as to whether or not to use TXA in this patient. Patients with significant extracranial bleeding will be excluded since there is evidence that TXA improves outcome in these patients. Treatment will entail a 1 g loading dose followed by a 1 g maintenance dose over 8 h.The main analyses will be on an 'intention-to-treat' basis, irrespective of whether the allocated treatment was received. Results will be presented as appropriate effect estimates with a measure of precision (95% confidence intervals). Subgroup analyses for the primary outcome will be based on time from injury to randomization, the severity of the injury, location of the bleeding, and baseline risk. Interaction tests will be used to test whether the effect of treatment differs across these subgroups. A study with 10,000 patients will have approximately 90% power to detect a 15% relative reduction from 20% to 17% in all-cause mortality.
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Neuropsychol Rehabil · Jan 2012
Randomized Controlled TrialMotivational interviewing and cognitive behaviour therapy for anxiety following traumatic brain injury: a pilot randomised controlled trial.
Although cognitive-behavioural therapy (CBT) is the treatment of choice for anxiety, its delivery needs to be adapted for individuals with traumatic brain injury (TBI). It also requires clients' active engagement for maximum benefit. This study was a pilot randomised controlled trial involving an anxiety treatment programme adapted for people with TBI, based on CBT and motivational interviewing (MI). ⋯ Participants receiving MI showed greater response to CBT, in terms of reduction in anxiety, stress and non-productive coping, compared to participants who received NDC. The results provided preliminary support for the adapted CBT programme, and the potential utility of MI as treatment prelude. Longer follow-up data are required to evaluate the maintenance of treatment effects.
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Randomized Controlled Trial
Decreasing adrenergic or sympathetic hyperactivity after severe traumatic brain injury using propranolol and clonidine (DASH After TBI Study): study protocol for a randomized controlled trial.
Severe TBI, defined as a Glasgow Coma Scale ≤ 8, increases intracranial pressure and activates the sympathetic nervous system. Sympathetic hyperactivity after TBI manifests as catecholamine excess, hypertension, abnormal heart rate variability, and agitation, and is associated with poor neuropsychological outcome. Propranolol and clonidine are centrally acting drugs that may decrease sympathetic outflow, brain edema, and agitation. However, there is no prospective randomized evidence available demonstrating the feasibility, outcome benefits, and safety for adrenergic blockade after TBI. ⋯ The DASH After TBI Study is the first randomized, double-blinded, placebo-controlled trial powered to determine feasibility and investigate safety and outcomes associated with adrenergic blockade in patients with severe TBI. If the study results in positive trends, this could provide pilot evidence for a larger multicenter randomized clinical trial. If there is no effect of therapy, this trial would still provide a robust prospective description of sympathetic hyperactivity after TBI.
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Randomized Controlled Trial
Exploring variables associated with change in cognitive behaviour therapy (CBT) for anxiety following traumatic brain injury.
In a pilot randomized controlled trial, we investigated the effectiveness of a 12-weekly anxiety treatment programme adapted for individuals with moderate-severe TBI, based on cognitive behaviour therapy (CBT) and Motivational Interviewing (MI). The current study explored the variables associated with treatment response and group differences in change expectancy and working alliance. ⋯ There is a need to further investigate the effectiveness of treatment for individuals with different injury severity and to explore the relationship between change expectancy and treatment outcome.