Magnetic Resonance Imaging Pilot Study of Intravenous Glyburide in Traumatic Brain Injury.
Adult
Brain Edema
/ diagnostic imaging
Brain Injuries, Traumatic
/ complications
Cerebral Hemorrhage
/ diagnostic imaging
Double-Blind Method
Female
Glyburide
/ administration & dosage
Humans
Image Interpretation, Computer-Assisted
/ methods
Infusions, Intravenous
Magnetic Resonance Imaging
/ methods
Male
Middle Aged
Neuroprotective Agents
/ administration & dosage
Pilot Projects
Young Adult
MRI
SUR1
TBI
contusion
edema
glyburide
Journal
Journal of neurotrauma
ISSN: 1557-9042
Titre abrégé: J Neurotrauma
Pays: United States
ID NLM: 8811626
Informations de publication
Date de publication:
01 01 2020
01 01 2020
Historique:
pubmed:
30
7
2019
medline:
13
4
2021
entrez:
30
7
2019
Statut:
ppublish
Résumé
Pre-clinical studies of traumatic brain injury (TBI) show that glyburide reduces edema and hemorrhagic progression of contusions. We conducted a small Phase II, three-institution, randomized placebo-controlled trial of subjects with TBI to assess the safety and efficacy of intravenous (IV) glyburide. Twenty-eight subjects were randomized and underwent a 72-h infusion of IV glyburide or placebo, beginning within 10 h of trauma. Of the 28 subjects, 25 had Glasgow Coma Scale (GCS) scores of 6-10, and 14 had contusions. There were no differences in adverse events (AEs) or severe adverse events (ASEs) between groups. The magnetic resonance imaging (MRI) percent change at 72-168 h from screening/baseline was compared between the glyburide and placebo groups. Analysis of contusions (7 per group) showed that lesion volumes (hemorrhage plus edema) increased 1036% with placebo versus 136% with glyburide (
Identifiants
pubmed: 31354055
doi: 10.1089/neu.2019.6538
pmc: PMC6921286
doi:
Substances chimiques
Neuroprotective Agents
0
Glyburide
SX6K58TVWC
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
185-193Subventions
Organisme : NHLBI NIH HHS
ID : R01 HL082517
Pays : United States
Organisme : NINDS NIH HHS
ID : R01 NS102589
Pays : United States
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