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
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage, Aneurysmal||Drug: Glibenclamide Other: Placebo||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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')
- 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.
- 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 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
|Contact: Bruno Braga Costa, MDfirstname.lastname@example.org|
|Contact: Eberval Figueiredo, MD PHDemail@example.com|
|Hospital das Clínicas da Faculdade de Medicina de São Paulo||Recruiting|
|São Paulo, SP, Brazil, 05403000|
|Contact: Eberval Figueiredo, MD PHD +551126617152 firstname.lastname@example.org|
|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|
|Study Chair:||Isabela Windlin||Neuropsicology|