NCT03569540

Brief Summary

A randomized, double-blind and prospective trial meant to evaluate the use of Glibenclamide on acute aneurysmatic subarachnoid hemorrhage. Patients will allocated randomly in two groups, one for 05 mg daily intake of glibenclamide for 21 days and another for control with placebo. General clinical data and late cognitive status will be accessed in both groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

July 3, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 26, 2018

Status Verified

January 1, 2018

Enrollment Period

12 months

First QC Date

May 17, 2018

Last Update Submit

June 14, 2018

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

Subarachnoid hemorrhageGlibenclamide

Outcome Measures

Primary Outcomes (3)

  • Modified Rankin Scale (early)

    Evaluate patients life quality and morbidity, from 1 to 6 ('no symptoms' to 'Death')

    To be measured on the 21th day of medication/control, when happens the end of intervention

  • Short-Form Healthy Survey Questionnaire (SF-36)

    Cognitive assessment and quality of Life measured by 11 questions that leads to a quantification scale called Raw Scale (RS). The RS identify 8 domains with a calculable score from 0 (worst) to 100 (best): Functional capacity; Limitation by physical aspects; Pain; General health; Vitality; Social aspects; Emotional aspects and Mental health.

    To be executed 6 months after the end of intervention

  • Modified Rankin Scale (late)

    Evaluate patients life quality and morbidity, from 1 to 6 ('no symptoms' to 'Death')

    To be measured 6 months after the end of intervention and compared with the early result

Study Arms (2)

Treated Patients

EXPERIMENTAL

Patients who will receive Glibenclamide 05mg daily for 21 days, orally or by nasogastric tube.

Drug: Glibenclamide

Control Group

PLACEBO COMPARATOR

Patients who will receive amylum 05mg daily for 21 days, orally or by nasogastric tube.

Other: Placebo

Interventions

GlibenclamideDRUG

Placebo-controlled; Double blind test

Treated Patients
PlaceboOTHER

Amylum

Control Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Radiological confirmatory evidence of an aneurysmal subarachnoid hemorrhage (by digital subtraction angiography, CT angiography, or magnetic resonance angiography)
  • Presentation less than 96 h from ictus

You may not qualify if:

  • Patients taking glibenclamide therapy at presentation
  • Pregnancy
  • Hunt \& Hess V
  • Known renal or hepatic impairment
  • Patient not fully independent before bleed,
  • Strong suspicion of drug or alcohol misuse
  • Patient taking warfarin-type drugs
  • Suspected additional life-threatening disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de São Paulo

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Publications (1)

  • da Costa BBS, Windlin IC, Koterba E, Yamaki VN, Rabelo NN, Solla DJF, Teixeira MJ, Figueiredo EG. Glibenclamide in aneurysmatic subarachnoid hemorrhage (GASH): study protocol for a randomized controlled trial. Trials. 2019 Jul 9;20(1):413. doi: 10.1186/s13063-019-3517-y.

    PMID: 31288831DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Officials

  • Isabela Windlin

    Neuropsicology

    STUDY CHAIR

Central Study Contacts

Bruno Braga Costa, MD

CONTACT

+5511995429966neurobraga@hotmail.com

Eberval Figueiredo, MD PHD

CONTACT

+551126617152ebgadelha@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

June 26, 2018

Study Start

July 3, 2018

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

June 26, 2018

Record last verified: 2018-01

Locations

BR(1)