To Evaluate the Effect of Glibenclamide in Reducing Brain Edema of TBI

NCT05148403 | Unknown Phase 1

• 1 other identifier: glibenclamide study group1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

Brain edema is one of the main mechanisms of secondary brain injury and one factor in the prognosis of traumatic brain injury . The clinical study of glibenclamide in the treatment of brain edema after traumatic brain injury is designed to evaluate whether glibenclamide treatment can improve the blood NSE and S100β levels of severe traumatic brain injury , so order to explore the efficacy and adverse effects of this drug in the treatment of traumatic brain injury .

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Serum NSE and S100 β level

  change of the serum NSE and S100 β level concentrations

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

Secondary Outcomes (5)

• Glasgow coma scale(GOS) score

  at 30 days

• Hospital mortality

  at 30 days

• The degree of brain edema

  at 3rd,7th days after recruitment

• The degree of midline displacement of brain CT

  at 3rd,7th days after recruitment

• 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: encephaledema

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:

• Closed craniocerebral trauma;
• The injury time on admission was less than 10 hours;
• The GCS score was less than 9, and the GCS score was evaluated without sedation or using muscle relaxants;
• They were 18-75 years old;
• Authorized close relatives to sign informed consent.

You may not qualify if:

• The damage time is uncertain;
• Penetrating brain injury;
• With spinal cord injury;
• Severe and fatal injuries associated with other parts of the body;
• Pregnant women or pregnancy test positive;
• Lactating women had lactation needs during the study period;
• blood suger is lower than 2.8 mmol / L;
• Renal insufficiency, history of dialysis treatment, or serum creatinine more than 2.5 mg / dl;
• The total bilirubin was more than 1.5 times of the upper limit;
• INR was greater than 1.4;
• Systolic blood pressure was less than 90 and had no response to fluid resuscitation;
• Allergic to sulfonylureas;
• There was a history of admission for brain injury, mental or neurological diseases within 3 years before brain injury;
• The drug use was restricted due to emergency operation within 8 hours after brain injury;
• There was a history of taking antiplatelet drugs, oral anticoagulants or heparin or low molecular weight heparin 72 hours before brain injury;

Sponsors & Collaborators

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

Study Sites (2)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Beijing Tongren Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

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 1
• 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: December 8, 2021
• Study Start: October 22, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-11

Locations

CN (2)