Evaluate the Use of Glibenclamide on Acute aSAH

NCT05137678 | Unknown Phase 4

• 1 other identifier: glibenclamide study group2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, open-labeled, blank-controlled and prospective trial meant to evaluate the use of glibenclamide on acute aneurysmatic subarachnoid hemorrhage. Patients will allocated randomly in two groups, one for 3.75 mg daily intake of glibenclamide for 7 days and another as a blank contrast. General clinical data and late cognitive status will be accessed in both groups.

Conditions

Subarachnoid Hemorrhage

Keywords

Subarachnoid hemorrhage; Brain aneurysms; Glibenclamide

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Serum neuron-specific enolase（NSE）

  change of NSE serum concentrations after treatment

  at 1st, 3rd,7th days after recruitment

• Change from Baseline Serum S100 β

  change of S100B serum concentrations after treatment

  at 1st, 3rd,7th days after recruitment

Secondary Outcomes (5)

• The proportion of modified Rankin score (0-2)

  at 90 days

• The degree of brain edema

  on the 3rd and 7th day after medication

• The incidence of delayed cerebral ischemia

  up to 3 weeks

• The incidence of hypoglycemia

  up to 7 days

• Intracranial pressure

  up to 7 days

Study Arms (2)

Experimental group

EXPERIMENTAL

Glibenclamide was given orally or through nasogastric tube, 1.25 mg every 8 hours for 7 days

Drug: glibenclamide

Control group

NO INTERVENTION

No glibenclamide treatment

Interventions

glibenclamide DRUG

Glibenclamide was given orally or by nasal feeding

Also known as: Glebenzene

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subarachnoid hemorrhage was diagnosed by digital subtraction angiography, computed tomographic angiogram or magnetic resonance angiography;
• Within 48 hours;
• Age \> 18 years old;
• The expected length of stay is more than 7 days;
• Sign informed consent.

You may not qualify if:

• There was a history of taking sulfonylureas within 30 days before brain injury;
• Combined with neurological or mental diseases, including stroke, epilepsy and dementia;
• Hunt \& Hess grade V patients;
• Severe brain injury (central hernia or hook hernia within 48 hours after admission or after resuscitation) that cannot be solved at present;
• History of alcohol or illicit drug dependence;
• Allergic to sulfonamides or glibenclamide tablets;
• The international normalized ratio was more than 1.4;
• Renal insufficiency, history of dialysis treatment or serum creatinine more than 2.5 mg / dl;
• Liver cirrhosis or severe liver dysfunction (ALT \> 2.5 times the upper normal limit or total bilirubin \> 1.5 times the upper normal limit);
• He is taking bosentan tablets to treat pulmonary hypertension;
• There was a history of glucose-6-phosphate dehydrogenase deficiency (faba bean disease);
• The life expectancy is less than one year;
• The gastrointestinal tract should not be used;
• Pregnancy or lactation;
• History of participating in other drug trials within 30 days;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Tongren Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (1)

• Lin Q, Zhou D, Ma J, Zhao J, Chen G, Wu L, Li T, Zhao S, Wen H, Yu H, Zhang S, Gao K, Yang R, Shi G. Efficacy and Safety of Early Treatment with Glibenclamide in Patients with Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial. Neurocrit Care. 2024 Dec;41(3):828-839. doi: 10.1007/s12028-024-01999-z. Epub 2024 Aug 8.

  PMID: 39117964 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Intracranial Aneurysm

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Aneurysm

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• guangzhi shi, doctor

  Beijing Tiantan Hospital

  STUDY CHAIR

Central Study Contacts

qing lin

CONTACT

13811127173; 13811127173@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label, result blind method
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Model Details: Patients in the case group were treated with glibenclamide within 10 hours after onset, orally or through nasogastric tube, 1.25 mg each time, once every 8 hours, for 7 consecutive days. The control group was blank control.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 30, 2021
• Study Start: October 19, 2021
• Primary Completion: October 19, 2022
• Study Completion: December 1, 2022
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

CN (1)