Subarachnoid Hemorrhage, AneurysmalPhase 4GASHNCT03569540
Glibenclamide in Aneurysmatic Subarachnoid Hemorrhage
A Phase 4 study testing Glibenclamide in people with Subarachnoid Hemorrhage, Aneurysmal, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Glibenclamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Jul 2018to 1 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Faculdade de Medicina de São Paulo
São Paulo, São Paulo, 05403000
Eberval Figueiredo, MD PHD, +551126617152, ebgadelha@yahoo.com
Bruno B Costa, MD
About this study
Official title: Glibenclamide in Aneurysmatic Subarachnoid Hemorrhage: A Prospective and Randomized Study
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.
Read the 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.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- Glibenclamide, Placebo
- Keywords
- Subarachnoid hemorrhage, Glibenclamide
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlibenclamideDrug
Placebo-controlled; Double blind test
PlaceboOther
Amylum
| Study group | Role | What they receive |
|---|---|---|
| Treated Patients | Experimental | Patients who will receive Glibenclamide 05mg daily for 21 days, orally or by nasogastric tube. Receives: Drug: Glibenclamide |
| Control Group | Placebo comparator | Patients who will receive amylum 05mg daily for 21 days, orally or by nasogastric tube. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (early)
Evaluate patients life quality and morbidity, from 1 to 6 ('no symptoms' to 'Death')
Measured: 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.
Measured: 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')
Measured: To be measured 6 months after the end of intervention and compared with the early result
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start3 Jul 2018 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabela Windlin, Study chair, Neuropsicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569540
- Sponsor's protocol ID
- 55947016.2.0000.0068
- Acronym
- GASH
- Status last verified
- Jan 2018
- First submitted
- 17 May 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31288831
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glibenclamide in Aneurysmatic Subarachnoid Hemorrhage: A Prospective and Randomized Study
- ClinicalTrials.gov ID
- NCT03569540
- Acronym / sponsor ID
- GASH / 55947016.2.0000.0068
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- Subarachnoid hemorrhage, Glibenclamide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 3 Jul 2018 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated Patients | Experimental | Drug: GlibenclamidePatients who will receive Glibenclamide 05mg daily for 21 days, orally or by nasogastric tube. |
| Control Group | Placebo comparator | Other: PlaceboPatients who will receive amylum 05mg daily for 21 days, orally or by nasogastric tube. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- Patients taking glibenclamide therapy at presentation
- Pregnancy
- Hunt \& Hess V
- Known renal or hepatic impairment
- Patient not fully independent before bleed,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlibenclamidePlacebo-controlled; Double blind test | Drug | Treated Patients |
| PlaceboAmylum | Other | Control Group |
Primary outcome
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')
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Derived from this study: PubMed 31288831da 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.
Related trials for Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabela Windlin study chair
Neuropsicology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glibenclamide in people with Subarachnoid Hemorrhage, Aneurysmal, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Braga Costa, MD (+5511995429966, neurobraga@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (early) (time frame: To be measured on the 21th day of medication/control, when happens the end of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.