Evidence map›Paper›PMID 31288831›Full record

ArticleTrials2019

Glibenclamide in aneurysmatic subarachnoid hemorrhage (GASH): study protocol for a randomized controlled trial.

Bruno Braga Sisnando da Costa, Isabela Costola Windlin, Edwin Koterba, Vitor Nagai Yamaki, Nícollas Nunes Rabelo, Davi Jorge Fontoura Solla, Manoel Jacobsen Teixeira, Eberval Gadelha Figueiredo

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03569540 (Glibenclamide in Aneurysmatic Subarachnoid Hemorrhage), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.9field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03569540 phase4unknown statusnot on this map

Glibenclamide in Aneurysmatic Subarachnoid Hemorrhage: A Prospective and Randomized Study

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2018 to 2019Enrolled50ConditionsSubarachnoid Hemorrhage, AneurysmalArmsGlibenclamide, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Review
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  4. Review
  5. Sulfonylurea Receptor 1 in Central Nervous System Injury: An Updated Review.International journal of molecular sciences · 2021
    Review
  6. Article
  7. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 2 countries.

Bruno Braga Sisnando da CostaNeurosurgery Department, University of São Paulo, São Paulo, SP, Brazil. neurobraga@hotmail.com.ORCID http://orcid.org/0000-0001-7746-213X
Isabela Costola WindlinNeurosurgery Department, University of São Paulo, São Paulo, SP, Brazil.
Edwin KoterbaNeurosurgery Department, University of São Paulo, São Paulo, SP, Brazil.
Vitor Nagai YamakiNeurosurgery Department, University of São Paulo, São Paulo, SP, Brazil.
Nícollas Nunes RabeloNeurosurgery Department, University of São Paulo, São Paulo, SP, Brazil.
Davi Jorge Fontoura SollaNeurosurgery Department, University of São Paulo, São Paulo, SP, Brazil.
Manoel Jacobsen TeixeiraNeurosurgery Department, University of São Paulo, São Paulo, SP, Brazil.
Eberval Gadelha FigueiredoNeurosurgery Department, University of São Paulo, São Paulo, SP, Brazil. ebgadelha@yahoo.com.br.
Universidade de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecent findings on the benefits of glibenclamide as a neuroprotective drug have started a new era for prospective studies on sulfonylureas. The effect of glibenclamide blocking the Sur1-Trpm4 channel was examined in models of subarachnoid hemorrhage and stroke, with findings of significantly reduced tight-junction abnormalities, resulting in less edema formation and considerably reduced transsynaptic apoptosis of hippocampal neurons and significantly ameliorated impairments in spatial learning. Based on these data, we plan a clinical trial to establish evidence of glibenclamide as an adjunct treatment in aneurysmal subarachnoid hemorrhage.

methodsAn estimated 80 patients meeting the inclusion criteria of radiological confirmatory evidence of an aneurysmal subarachnoid hemorrhage, age 18-70 years, and presentation of less than 96 h from the ictus will be allocated randomly into two groups, one receiving 5 mg daily oral intake of glibenclamide for 21 days and another control group receiving a placebo. The study's primary outcome is the modified Rankin scale (mRS) after 6 months, as favorable (mRS 0-2) or unfavorable (mRS 3-6). The secondary outcomes will be late cognitive status, assessed after 6 months by psychological tests (the Short Form Health Survey Questionnaire and the Montreal Cognitive Assessment), as well as death at 6 months, delayed cerebral ischemia and occurrence of serious adverse events due to study medication. DISCUSSION: There is a growing interest in the scientific community regarding glibenclamide in brain edema and traumatic brain injury, but with very little of this interest targeting spontaneous brain hemorrhage, especially aneurism rupture. Positive outcomes are expected for the treatment patients, especially in language and memory preservation, as has been shown in experimental models.

trial registrationClinicalTrials.gov, NCT03569540 . Retrospectively registered on 26 June 2018.

Indexed as

AdolescentAdultAgedBrainBrazilCognitionDouble-Blind MethodFemaleGlyburideHumansMaleMiddle AgedNeuroprotective AgentsProspective StudiesRandomized Controlled Trials as TopicSubarachnoid HemorrhageGlyburideNeuroprotective AgentsBrain aneurysmsGlibenclamideSubarachnoid hemorrhage

Identifiers

PMID31288831
PMCPMC6617901
OpenAlexW2956380232

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.