- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03569540
Glibenclamide in Aneurysmatic Subarachnoid Hemorrhage (GASH)
Glibenclamide in Aneurysmatic Subarachnoid Hemorrhage: A Prospective and Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Bruno Braga Costa, MD
- Phone Number: +5511995429966
- Email: neurobraga@hotmail.com
Study Contact Backup
- Name: Eberval Figueiredo, MD PHD
- Phone Number: +551126617152
- Email: ebgadelha@yahoo.com
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 05403000
- Recruiting
- Hospital das Clínicas da Faculdade de Medicina de São Paulo
-
Contact:
- Eberval Figueiredo, MD PHD
- Phone Number: +551126617152
- Email: ebgadelha@yahoo.com
-
Principal Investigator:
- Bruno B Costa, MD
-
Sub-Investigator:
- Isabella Windlin, MD
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Sub-Investigator:
- Nicollas R Nunes, MD
-
Sub-Investigator:
- Vitor N Yamaki, MD
-
Sub-Investigator:
- Edwin Koterba, MD, PHD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treated Patients
Patients who will receive Glibenclamide 05mg daily for 21 days, orally or by nasogastric tube.
|
Placebo-controlled; Double blind test
|
PLACEBO_COMPARATOR: Control Group
Patients who will receive amylum 05mg daily for 21 days, orally or by nasogastric tube.
|
Amylum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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')
|
To be measured on the 21th day of medication/control, when happens the end of intervention
|
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.
|
To be executed 6 months after the end of intervention
|
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')
|
To be measured 6 months after the end of intervention and compared with the early result
|
Collaborators and Investigators
Investigators
- Study Chair: Isabela Windlin, Neuropsicology
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 55947016.2.0000.0068
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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