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Evaluation of the Effect of Glibenclamide in Patients With Diffuse Axonal Injury Due to Moderate to Severe Head Trauma.

ABSTRACT: Traumatic brain injury (TBI) is a major health problem worldwide. Secondary injuries after TBI, including diffuse axonal injury (DAI) often occur, and proper treatments are needed in this regard. It has been shown that glibenclamide could reduce secondary brain damage after experimental TBI and improve outcomes.We aim to evaluate the role of glibenclamide on the short-term outcome of patients with DAI due to moderate to severe TBI.In this controlled randomized clinical trial, 40 patients with moderate to severe TBI were assigned to glibenclamide (n = 20) and control (n = 20) groups. Six hours after admission the intervention group received 1.25 mg glibenclamide every 12 hours. The Glasgow coma scale (GCS) was administered at admission, in the first 24 and 48 hours, at one week post-trauma and at discharge. The Glasgow outcome scale (GOS) was also administered at discharge. All results were evaluated and compared between groups.Patients treated with glibenclamide compared to the control group had a significantly better GCS score one week post-trauma (P = 0.003) and at discharge (P = 0.004), as well as a better GOS score at discharge (P = 0.001). The glibenclamide group also had a shorter length of hospital stay compared to the control group (P = 0.03). In the control group, two patients (10%) died during the first week post-trauma, but there was no mortality in the glibenclamide group (P = 0.48).Treatment with glibenclamide in patients with DAI due to moderate to severe TBI significantly improves short-term outcomes.

SUBMITTER: Zafardoost P

PROVIDER: S-EPMC5292034 | biostudies-other | 2016 Nov

REPOSITORIES: biostudies-other

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Evaluation of the Effect of Glibenclamide in Patients With Diffuse Axonal Injury Due to Moderate to Severe Head Trauma.

Zafardoost Peyman P Ghasemi Amir Abbas AA Salehpour Firooz F Piroti Chia C Ziaeii Ehsan E

Trauma monthly 20160424 5

<h4>Background</h4>Traumatic brain injury (TBI) is a major health problem worldwide. Secondary injuries after TBI, including diffuse axonal injury (DAI) often occur, and proper treatments are needed in this regard. It has been shown that glibenclamide could reduce secondary brain damage after experimental TBI and improve outcomes.<h4>Objectives</h4>We aim to evaluate the role of glibenclamide on the short-term outcome of patients with DAI due to moderate to severe TBI.<h4>Patients and methods</h ...[more]

PMID: 28184360

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Project description:BACKGROUND:Diffuse axonal injury (DAI) on magnetic resonance imaging has been associated with poor functional outcome after moderate-severe traumatic brain injury (msTBI). Yet, DAI assessment with highly sensitive magnetic resonance imaging techniques is unfeasible in the acute trauma setting, and computed tomography (CT) remains the key diagnostic modality despite its lower sensitivity. We sought to determine whether CT-defined hemorrhagic DAI (hDAI) is associated with discharge and favorable 3- and 12-month functional outcome (Glasgow Coma Scale score ≥4) after msTBI. METHODS:We analyzed 361 msTBI patients from the single-center longitudinal Outcome Prognostication in Traumatic Brain Injury study collected over 6 years (November 2009 to November 2015) with prospective outcome assessments at 3 months and 12 months. Patients with microhemorrhages on CT were designated "CT-hDAI-positive" and those without as "CT-hDAI-negative." For secondary analyses "CT-hDAI-positive" was stratified into two phenotypes according to presence ("associated") versus absence ("predominant") of concomitant large acute traumatic lesions to determine whether presence versus absence of additional focal mass lesions portends a different prognosis. RESULTS:Seventy (19%) patients were CT-hDAI-positive (n = 36 predominant; n = 34 associated hDAI). In univariate analyses, CT-hDAI-positive status was associated with discharge survival (p = 0.004) and favorable outcome at 3 months (p = 0.003) and 12 months (p = 0.005). After multivariable adjustment, CT-hDAI positivity was no longer associated with discharge survival and functional outcome (all ps > 0.05). Stratified by hDAI phenotype, predominant hDAI patients had worse trauma severity, longer intensive care unit stays, and more systemic medical complications. Predominant hDAI, but not associated hDAI, was an independent predictor of discharge survival (adjusted odds ratio, 24.7; 95% confidence interval [CI], 3.2-192.6; p = 0.002) and favorable 12-month outcome (adjusted odds ratio, 4.7; 95% CI, 1.5-15.2; p = 0.01). Sensitivity analyses using Cox regression confirmed this finding for 1-year survival (adjusted hazard ratio, 5.6; 95% CI, 1.3-23; p = 0.048). CONCLUSION:The CT-defined hDAI was not an independent predictor of unfavorable short- and long-term outcomes and should not be used for acute prognostication in msTBI patients. Predominant hDAI patients had good clinical outcomes when supported to intensive care unit discharge and beyond. LEVEL OF EVIDENCE:Prognostic study, level III.

Project description:BackgroundTraumatic brain injury (TBI) is the leading cause of death and disability in children, but effective tools for predicting outcome remain elusive. Although many pediatric patients receive early magnetic resonance imaging (MRI), data on its utility in prognostication are lacking. Diffuse axonal injury (DAI) is a hallmark of TBI detected on early MRI and was shown previously to improve prognostication in adult patients with TBI. In this exploratory study, we investigated whether DAI grade correlates with functional outcome and improves prognostic accuracy when combined with core clinical variables and computed tomography (CT) biomarkers in pediatric patients with moderate-severe TBI (msTBI).MethodsPediatric patients (≤ 19 years) who were admitted to two regional level one trauma centers with a diagnosis of msTBI (Glasgow Coma Scale [GCS] score < 13) between 2011 and 2019 were identified through retrospective chart review. Patients who underwent brain MRI within 30 days of injury and had documented clinical follow-up after discharge were included. Age, pupil reactivity, and initial motor GCS score were collected as part of the International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) model. Imaging was reviewed to calculate the Rotterdam score (CT) and DAI grade (MRI) and to evaluate for presence of hypoxic-ischemic injury (MRI). The primary outcome measure was the Pediatric Cerebral Performance Category Scale (PCPCS) score at 6 months after TBI, with favorable outcome defined as PCPCS scores 1-3 and unfavorable outcome defined as PCPCS scores 4-6. The secondary outcome measure was discharge disposition to home versus to an inpatient rehabilitation facility.ResultOf 55 patients included in the study, 45 (82%) had severe TBI. The most common mechanism of injury was motor vehicle collision (71%). Initial head CT scans showed acute hemorrhage in 84% of patients. MRI was acquired a median of 5 days after injury, and hemorrhagic DAI lesions were detected in 87% of patients. Each 1-point increase in DAI grade increased the odds of unfavorable functional outcome by 2.4-fold. When controlling for core IMPACT clinical variables, neither the DAI grade nor the Rotterdam score was independently correlated with outcome and neither significantly improved outcome prediction over the IMPACT model alone.ConclusionsA higher DAI grade on early MRI is associated with worse 6-month functional outcome and with discharge to inpatient rehabilitation in children with acute msTBI in a univariate analysis but does not independently correlate with outcome when controlling for the GCS score. Addition of the DAI grade to the core IMPACT model does not significantly improve prediction of poor neurological outcome. Further study is needed to elucidate the utility of early MRI in children with msTBI.

Project description:BackgroundPhotobiomodulation describes the use of red or near-infrared light to stimulate or regenerate tissue. It was discovered that near-infrared wavelengths (800-900 nm) and red (600 nm) light-emitting diodes (LED) are able to penetrate through the scalp and skull and have the potential to improve the subnormal cellular activity of compromised brain tissue. Different experimental and clinical studies were performed to test LED therapy for traumatic brain injury (TBI) with promising results. One of the proposals of this present study is to develop different approaches to maximize the positive effects of this therapy and improve the quality of life of TBI patients.Methods/designThis is a double-blinded, randomized, controlled trial of patients with diffuse axonal injury (DAI) due to a severe TBI in an acute stage (less than 8 h). Thirty two patients will be randomized to active coil helmet and inactive coil (sham) groups in a 1:1 ratio. The protocol includes 18 sessions of transcranial LED stimulation (627 nm, 70 mW/cm2, 10 J/cm2) at four points of the frontal and parietal regions for 30 s each, totaling 120 s, three times per week for 6 weeks, lasting 30 min. Patients will be evaluated with the Glasgow Outcome Scale Extended (GOSE) before stimulation and 1, 3, and 6 months after the first stimulation. The study hypotheses are as follows: (1) transcranial LED therapy (TCLT) will improve the cognitive function of DAI patients and (2) TCLT will promote beneficial hemodynamic changes in cerebral circulation.DiscussionThis study evaluates early and delayed effects of TCLT on the cognitive rehabilitation for DAI following severe acute TBI. There is a paucity of studies regarding the use of this therapy for cognitive improvement in TBI. There are some experimental studies and case series presenting interesting results for TBI cognitive improvement but no clinical trials.Trial registrationClinicalTrials.gov, NCT03281759 . Registered on 13 September 2017.

Dataset Information

Evaluation of the Effect of Glibenclamide in Patients With Diffuse Axonal Injury Due to Moderate to Severe Head Trauma.

Publications

Evaluation of the Effect of Glibenclamide in Patients With Diffuse Axonal Injury Due to Moderate to Severe Head Trauma.

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