Journal of neurotrauma
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Journal of neurotrauma · Jun 2021
Randomized Controlled TrialRestart TICrH Trial Design: an adaptive randomized trial of time intervals to restart direct oral anticoagulants after traumatic intracranial hemorrhage.
Anticoagulants prevent thrombosis and death in patients with atrial fibrillation and venous thromboembolism (VTE) but also increase bleeding risk. The benefit/risk ratio favors anticoagulation in most of these patients. However, some will have a bleeding complication, such as the common trip-and-fall brain injury in elderly patients that results in traumatic intracranial hemorrhage. ⋯ Clinicians generally agree that anticoagulation should be restarted but disagree about when. This uncertainty leads to long restart delays causing a large, potentially preventable burden of strokes and VTE, which has been unaddressed because of the absence of high quality evidence. Restart Traumatic Intracranial Hemorrhage (the "r" distinguished intracranial from intracerebral) (TICrH) is a prospective randomized open label blinded end-point response-adaptive clinical trial that will evaluate the impact of delays to restarting direct oral anticoagulation (1, 2, or 4 weeks) on the composite of thrombotic events and bleeding in patients presenting after traumatic intracranial hemorrhage.
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Journal of neurotrauma · Jun 2021
Randomized Controlled Trial Multicenter StudyCorticosteroids as an adjuvant treatment to Surgery in Chronic Subdural Hematomas: a multicenter double-blind randomized placebo-controlled trial.
Chronic subdural hematoma (CSDH) is a common condition necessitating surgery; however, recurrence occurs in 15-25% of cases despite surgical management. The HEMACORT trial was a prospective randomized, double-blind, placebo-controlled, multi-centric study (NCT01380028). The aim of this trial was to determine the effect of corticosteroids as an adjuvant treatment to surgery on CSDH recurrence at 6 months. ⋯ Among adverse events, sleep disorders occurred more often in the prednisone group (26.1% vs. 9.1%, p = 0.02). The HEMACORT trial data suggest that prednisone, as an adjuvant treatment to surgery, may reduce early radiological recurrence of CSDH, although clinical benefits are unclear. In view of these findings, the authors suggest that shorter treatment duration should be assessed for safety and efficacy in future trials.
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Journal of neurotrauma · Apr 2021
Randomized Controlled TrialEfficacy of Melatonin for sleep disturbance in children with persistent post-concussion symptoms: secondary analysis of a randomized controlled trial.
Sleep disturbances are commonly reported in children with persistent post-concussion symptoms (PPCS). Melatonin treatment is often recommended, yet supporting evidence is scarce. We aimed to evaluate the efficacy of treatment with melatonin for sleep disturbance in youth with PPCS following mild traumatic brain injury (mTBI). ⋯ Changes in cognition or behavior were otherwise not significantly different between treatment groups. Short-term melatonin is a well-tolerated treatment for sleep disturbance in youth with PPCS following mTBI. In this context, it may also be associated with a reduction in depressive symptoms.
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Journal of neurotrauma · Mar 2021
Randomized Controlled Trial Multicenter StudyComputer-Assisted Measurement of Traumatic Brain Hemorrhage Volume is More Predictive of Functional Outcome and Mortality than Standard ABC/2 Method: An Analysis of CT Imaging Data from the ProTECTIII Trial.
Hemorrhage volume is an important variable in emergently assessing traumatic brain injury (TBI). The most widely used method for rapid volume estimation is ABC/2, a simple algorithm that approximates lesion geometry as perfectly ellipsoid. The relative prognostic value of volume measurement based on more precise hematoma topology remains unknown. ⋯ Across all lesions, volume was significantly associated with outcome using either method (p < 0.001), but CAV measurement was a significantly better predictor of outcome than ABC/2 estimation for SDH. Among large traumatic SDH, ABC/2 significantly overestimates lesion volume compared with measurement based on precise bleed topology. CAV also offers significantly better prediction of patient functional outcofme and mortality.
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Journal of neurotrauma · Mar 2021
Randomized Controlled TrialGoal-Oriented Attention Self-Regulation Training Improves Executive Functioning in Veterans with PTSD and Mild TBI.
Difficulties in executive-control functions are common sequelae of both traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). The goal of this study was to assess whether a cognitive rehabilitation training that was applied successfully in civilian and military TBI would be effective for military Veterans with comorbid PTSD and mild TBI (mTBI). In the previous study, Veterans with a history of mild to severe TBI improved significantly after goal-oriented attentional self-regulation (GOALS) training on measures of attention/executive function, functional task performance, and emotional regulation. ⋯ In addition, GOALS but not BHE participants indicated a significant decrease in PTSD symptoms (PCL-M Total Score) (F = 4.80, p = 0.05, Cohen d = 0.60), and demonstrated improvement on complex functional task performance-GPS Learning and Memory (F = 5.06, p = 0.05, Cohen d = 0.56]. Training in attentional self-regulation applied to participant-defined goals may improve cognitive functioning in Veterans with comorbid PTSD and mTBI. Improving cognitive control functioning may also improve functioning in other domains such as emotional regulation and functional performance, potentially making it particularly relevant for Veterans with a history of mTBI and comorbid psychiatric symptoms.