Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03569540
Other study ID # 55947016.2.0000.0068
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 3, 2018
Est. completion date December 1, 2019

Study information

Verified date January 2018
Source University of Sao Paulo General Hospital
Contact Bruno Braga Costa, MD
Phone +5511995429966
Email neurobraga@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. General clinical data and late cognitive status will be accessed in both groups.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Glibenclamide
Placebo-controlled; Double blind test
Other:
Placebo
Amylum

Locations

Country Name City State
Brazil Hospital das Clínicas da Faculdade de Medicina de São Paulo São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06032533 - Remote Ischemic Conditioning in Aneurysmal SAH N/A
Completed NCT05131295 - Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage. Phase 3
Recruiting NCT04583163 - Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients
Recruiting NCT06006975 - Early Warning of Delayed Cerebral Ischemia
Terminated NCT02893826 - Safety/Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With aSAH Phase 1
Unknown status NCT01567449 - Risk Factors for Aneurysm Rebleeding N/A
Recruiting NCT05095857 - The Anesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury Phase 4
Not yet recruiting NCT04512859 - Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage N/A
Recruiting NCT05103566 - Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage N/A
Not yet recruiting NCT04696523 - Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage Phase 2
Completed NCT04415736 - Artificial Intelligence in Subarachnoid Hemorrhage
Recruiting NCT05925478 - Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage Early Phase 1
Recruiting NCT04649398 - Cerebral Nimodipine Concentrations Following Oral, Intra-venous and Intra-arterial Administration
Recruiting NCT02995928 - Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage N/A
Recruiting NCT04945603 - Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group
Active, not recruiting NCT06239142 - Understanding Mental Fatigue After Subarachnoid Hemorrhage
Completed NCT03318783 - Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial Phase 1/Phase 2
Terminated NCT05686265 - Cerebral Nitrosative/Oxidative Stress in Aneurysmal Subarachnoid Haemorrhage
Not yet recruiting NCT06359782 - Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH) Phase 2
Not yet recruiting NCT06057155 - Intracranial Pressure and Optic Nerve Sheath Diameter With CLOSED Bundle