Journal of neurotrauma
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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 · Jun 2021
Multicenter StudyMissing data in prediction research: A five step approach for multiple imputation, illustrated in the CENTER-TBI study.
In medical research, missing data is common. In acute diseases, such as traumatic brain injury (TBI), even well-conducted prospective studies may suffer from missing data in baseline characteristics and outcomes. Statistical models may simply drop patients with any missing values, potentially leaving a selected subset of the original cohort. ⋯ We hereto propose a five-step approach, centered around single and multiple imputation: 1) explore the missing data patterns; 2) choose a method of imputation; 3) perform imputation; 4) assess diagnostics of the imputation; and 5) analyze the imputed data sets. We illustrate these five steps with the estimation and validation of the IMPACT (International Mission on Prognosis and Analysis of Clinical Trials in Traumatic Brain Injury) prognostic model in 1375 patients from the CENTER-TBI database, included in 53 centers across 17 countries, with moderate or severe TBI in the prospective European CENTER-TBI study. Future prediction modeling studies in acute diseases may benefit from following the suggested five steps for optimal statistical analysis and interpretation, after maximal effort has been made to minimize missing data.
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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
Multicenter StudyEvolution of Irritability, Anger, and Aggression after Traumatic Brain Injury: Identifying and Predicting Subgroups.
The current prospective, multi-center, longitudinal cohort study examined how veterans/service members (V/SM) changed in their irritability, anger, and aggression (IAA) scores from admission to discharge in post-acute rehabilitation settings. The goals were to identify trajectory subgroups, and explore if there were different predictors of the subgroups. V/SM (n = 346) from five Veterans Affairs TBI Model Systems Polytrauma Rehabilitation Centers participated. ⋯ The majority of V/SM had persistent impairment from IAA, a quarter of the sample had no impairment from IAA, and fewer participants had resolving or worsening IAA. Findings emphasize the importance of educating providers and family of the different ways and times that IAA can manifest after TBI. Timely diagnosis and treatment of PTSD symptoms during and after rehabilitation are critical treatment targets.
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Journal of neurotrauma · Jun 2021
Meta AnalysisThe effect of growth hormone on neuropsychological outcomes and quality of life of patients with traumatic brain injury: a systematic review.
One of the most devastating chronic consequences of traumatic brain injury (TBI) is cognitive impairment. One of the possible underlying causes is growth hormone deficiency (GHD) caused by TBI-induced hypopituitarism. Currently, TBI patients are not routinely screened for pituitary function, and there are no standard therapies when GHD is diagnosed. ⋯ After TBI, regardless of GCS, 6-12 months of GH therapy, started in the chronic phase post-TBI, induced a moderate improvement in processing speed and memory capacities, decreased the severity of depression, and led to a marked improvement in quality of life. Limitations include the relatively low number of patients involved and the divergent neuropsychological tests used. These results indicate the need for further multi-centric controlled studies to substantiate the use of GH replacement therapy as a potential tool to alleviate TBI-related cognitive impairment and improve quality of life.