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Glibenclamide in Aneurysmatic Subarachnoid Hemorrhage (GASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03569540
Recruitment Status : Unknown
Verified January 2018 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : June 26, 2018
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage, Aneurysmal Drug: Glibenclamide Other: Placebo Phase 4

Detailed Description:

GASH is a double blind, prospective and randomized clinical trial centered on the University of Sao Paulo General Hospital. Patients will be recruited from neurological/neurosurgical intensive care units. Appropriate ethics and regulatory approvals will be sought for all subjects, according to the International Conference on Harmonization guidelines for good clinical practice (ICH GCP). Investigators will obtain informed written consent from all patients or their legal representative. Recruitment will take place between 2018 and 2019.

Patients will be randomly assigned (1:1) to receive either glibenclamide 5mg or placebo. Coded boxes containing either 21 similar tablets of glibenclamide 5mg or placebo will be assigned a number. A computer-generated randomization code will be used to randomize patients by blocks of ten (five glibenclamide, five placebo). Each box will be identified by a code number specific and subsequently selected for distribution in ascending numerical order. Patients will start treatment as soon as possible within 96 h of the ictus, with a daily dose till the 21° day after the bleed. Trial medication consisted of one tablet a day, given orally or via a nasogastric tube. Aneurysm treatment, either by microsurgery or embolization, will be performed as soon as possible, according with the standard of care for the recruiting center. Nimodipine 60mg, every four hours, will be started on admission and continued till the 21° day after the ictus, in all patients as standard of care.

Patient's demographics, medical history and relevant investigation results will be collected. The severity of the hemorrhage will be clinically assessed by World Federation of Neurosurgical Societies grading scale and radiologically using the modified Fischer scale. At 6 months of follow up patients will be interviewed with modified Rankin scale (mRS) questionnaire (a scale that measures degree of incapacity/ dependence and mortality after neurological events) by a nurse or a physician with no knowledge of treatment allocation. Psychologists will evaluate quality of life and cognitive performance using the "short-form health survey questionnaire" (SF-36) and neuropsychological tests. The main hypothesis is that, once compared with standard of care, glibenclamide 5mg will provide better clinical outcome and additionally will decrease mortality and improve quality of life and cognitive performance after 6 months.

Sample size: It was estimated the sample size of 50 randomized patients to give 90% power at the 5% significance level (two-sided) to detect a treatment effect equivalent to an absolute increase of 7% in the proportion of patients with a favorable outcome (30-day mortality rate after subarachnoid hemorrhage approaches 50% and 25% of survivors present some degree of neurological morbidity25). This calculation was based on an ordinal analysis of the 6-month mRS (the primary outcome) assuming that the treatment effect follows a proportional odds model.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Glibenclamide in Aneurysmatic Subarachnoid Hemorrhage: A Prospective and Randomized Study
Estimated Study Start Date : July 3, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Glyburide

Arm Intervention/treatment
Experimental: Treated Patients
Patients who will receive Glibenclamide 05mg daily for 21 days, orally or by nasogastric tube.
Drug: Glibenclamide
Placebo-controlled; Double blind test

Placebo Comparator: Control Group
Patients who will receive amylum 05mg daily for 21 days, orally or by nasogastric tube.
Other: Placebo
Amylum




Primary Outcome Measures :
  1. Modified Rankin Scale (early) [ Time Frame: To be measured on the 21th day of medication/control, when happens the end of intervention ]
    Evaluate patients life quality and morbidity, from 1 to 6 ('no symptoms' to 'Death')

  2. Short-Form Healthy Survey Questionnaire (SF-36) [ Time Frame: To be executed 6 months after the end of intervention ]
    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.

  3. Modified Rankin Scale (late) [ Time Frame: To be measured 6 months after the end of intervention and compared with the early result ]
    Evaluate patients life quality and morbidity, from 1 to 6 ('no symptoms' to 'Death')



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569540


Contacts
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Contact: Bruno Braga Costa, MD +5511995429966 neurobraga@hotmail.com
Contact: Eberval Figueiredo, MD PHD +551126617152 ebgadelha@yahoo.com

Locations
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Brazil
Hospital das Clínicas da Faculdade de Medicina de São Paulo Recruiting
São Paulo, SP, Brazil, 05403000
Contact: Eberval Figueiredo, MD PHD    +551126617152    ebgadelha@yahoo.com   
Principal Investigator: Bruno B Costa, MD         
Sub-Investigator: Isabella Windlin, MD         
Sub-Investigator: Nicollas R Nunes, MD         
Sub-Investigator: Vitor N Yamaki, MD         
Sub-Investigator: Edwin Koterba, MD, PHD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Chair: Isabela Windlin Neuropsicology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03569540    
Other Study ID Numbers: 55947016.2.0000.0068
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Sao Paulo General Hospital:
Subarachnoid hemorrhage
Glibenclamide
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs