External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension: A Phase 1 Randomized, Allocation-concealed, Open-label, Safety and Feasibility Clinical Trial

The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift <5mm without increasing the risk of neurological worsening or cerebral herniation.
All participants will receive routine usual care. The study group will additionally have ELD for cerebrospinal fluid (CSF) drainage. A comparison will be made between the usual treatment plus ELD (interventional) groups, and the usual treatment (control) groups on incidence rate of neurological worsening or cerebral herniation events, and whether total hours with raised intracranial pressure (ICP) are different.

开始日期2024-06-24

申办/合作机构

Brain Trauma Foundation, Inc

[+3]

NCT02877732 / TerminatedN/AIIT

EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 2

This is a prospective multi-center cohort feasibility and exploratory study.

开始日期2016-07-01

申办/合作机构

Stanford University

[+5]

NCT02844543 / CompletedN/AIIT

EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 1

This study will assess the effects of exercise and non-concussive bodily contact on eye-tracking scores collected by the EYE-SYNC eye-tracking device.

开始日期2016-01-01

申办/合作机构

Stanford University

[+5]

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2023-12-01·Concussion

Dual statistical models link baseline visual attention measure to risk for significant symptomatic concussion in sports

Article

作者: Maruta, Jun ; Spielman, Lisa A ; Ghajar, Jamshid

Aim: Athletic pre-season testing can establish functional baseline for comparison following concussion. Whether impacts of future concussions may be foretold by such testing is little known. Materials & methods: Two sets of models for a significant burden of concussion were generated: a traditional approach using a series of logistic regressions, and a penalized regression approach using elastic net. Results: 3091 youth and adult athletes were baseline-assessed. 90 subsequently experienced concussion and 35 were still experiencing a significant burden of concussion when tested within two weeks. Both models associated prior history of head injury and visual attention-related metrics with a significant burden of concussion. Conclusion: Pre-season testing of visual attention may identify athletes who are at risk for significant sports-related concussion.

2023-09-26·Neurosurgery

Guidelines for Prehospital Management of Traumatic Brain Injury 3rd Edition: Executive Summary

Article

作者: Bell, Randy ; Bobrow, Bentley J. ; Ghajar, Jamshid ; Lulla, Al ; Jagoda, Andy ; Hawryluk, Gregory W. J. ; Mangat, Halinder S.

Prehospital care markedly influences outcome from traumatic brain injury, yet it remains highly variable. The Brain Trauma Foundation's guidelines informing prehospital care, first published in 2002, have sought to identify and disseminate best practices. Many of its recommendations relate to the management of airway, breathing and circulation, and infrastructure for this care. Compliance with the second edition of these guidelines has been associated with significantly improved survival. A working group developed evidence-based recommendations informing assessment, treatment, and transport decision-making relevant to the prehospital care of brain injured patients. A literature search spanning May 2005 to January 2022 supplemented data contained in the 2nd edition. Identified studies were assessed for quality and used to inform evidence-based recommendations. A total of 122 published articles formed the evidentiary base for this guideline update including 5 providing Class I evidence, 35 providing Class II evidence, and 98 providing Class III evidence for the various topics. Forty evidence-based recommendations were generated, 30 of which were strong and 10 of which were weak. In many cases, new evidence allowed guidelines from the 2nd edition to be strengthened. Development of guidelines on some new topics was possible including the prehospital administration of tranexamic acid. A management algorithm is also presented. These guidelines help to identify best practices for prehospital traumatic brain injury care, and they also identify gaps in knowledge which we hope will be addressed before the next edition.

2023-08-01·Neurosurgery

Perceived Utility of Intracranial Pressure Monitoring in Traumatic Brain Injury: A Seattle International Brain Injury Consensus Conference Consensus-Based Analysis and Recommendations

Article

作者: Gao, Guoyi ; Harris, Odette ; Diringer, Michael ; Ullman, Jamie S. ; Oddo, Mauro ; Taccone, Fabio Silvio ; Tsai, Eve C. ; Cooper, D. Jamie ; Okonkwo, David O. ; Hoffer, Alan ; Sahuquillo, Juain ; Menon, David K ; Michael, Daniel B. ; Stocchetti, Nino ; Meyfroidt, Geert ; Rubiano, Andres M. ; Chesnut, Randall M. ; Servadei, Franco ; Hutchinson, Peter ; Kitagawa, Ryan ; Timmons, Shelly D. ; Citerio, Giuseppe ; Videtta, Walter ; Aguilera, Sergio ; Patel, Mayur B. ; Hawryluk, Gregory W. J. ; Ghajar, Jamshid ; Rosenfeld, Jeffrey V. ; Stein, Deborah M. ; Wright, David W. ; Arrastia, Ramon Diaz ; Robertson, Claudia ; Buki, Andras ; Geocadin, Romergryko G. ; Shutter, Lori ; Zammit, Christopher ; Manley, Geoffrey ; Mayer, Stephan ; Joseph, Mathew ; Figaji, Anthony ; Bulger, Eileen M.

BACKGROUND:Intracranial pressure (ICP) monitoring is widely practiced, but the indications are incompletely developed, and guidelines are poorly followed.OBJECTIVE:To study the monitoring practices of an established expert panel (the clinical working group from the Seattle International Brain Injury Consensus Conference effort) to examine the match between monitoring guidelines and their clinical decision-making and offer guidance for clinicians considering monitor insertion.METHODS:We polled the 42 Seattle International Brain Injury Consensus Conference panel members' ICP monitoring decisions for virtual patients, using matrices of presenting signs (Glasgow Coma Scale [GCS] total or GCS motor, pupillary examination, and computed tomography diagnosis). Monitor insertion decisions were yes, no, or unsure (traffic light approach). We analyzed their responses for weighting of the presenting signs in decision-making using univariate regression.RESULTS:Heatmaps constructed from the choices of 41 panel members revealed wider ICP monitor use than predicted by guidelines. Clinical examination (GCS) was by far the most important characteristic and differed from guidelines in being nonlinear. The modified Marshall computed tomography classification was second and pupils third. We constructed a heatmap and listed the main clinical determinants representing 80% ICP monitor insertion consensus for our recommendations.CONCLUSION:Candidacy for ICP monitoring exceeds published indicators for monitor insertion, suggesting the clinical perception that the value of ICP data is greater than simply detecting and monitoring severe intracranial hypertension. Monitor insertion heatmaps are offered as potential guidance for ICP monitor insertion and to stimulate research into what actually drives monitor insertion in unconstrained, real-world conditions.

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