Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-28 @ 12:54 PM
Study NCT ID:
NCT05148403
Status:
UNKNOWN
Last Update Posted:
2021-12-08
First Post:
2021-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Effect of Glibenclamide in Reducing Brain Edema of TBI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005905', 'term': 'Glyburide'}], 'ancestors': [{'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label, result blind method'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-11-24', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum NSE and S100 β level', 'timeFrame': 'at 1st, 3rd,7th days after recruitment', 'description': 'change of the serum NSE and S100 β level concentrations'}], 'secondaryOutcomes': [{'measure': 'Glasgow coma scale(GOS) score', 'timeFrame': 'at 30 days', 'description': 'Glasgow coma scale(GOS) score'}, {'measure': 'Hospital mortality', 'timeFrame': 'at 30 days', 'description': 'Hospital mortality'}, {'measure': 'The degree of brain edema', 'timeFrame': 'at 3rd,7th days after recruitment', 'description': 'measured by CT'}, {'measure': 'The degree of midline displacement of brain CT', 'timeFrame': 'at 3rd,7th days after recruitment', 'description': 'The degree of midline displacement of brain CT'}, {'measure': 'Intracranial pressure', 'timeFrame': 'up to 7 days', 'description': 'if have'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': '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 .', 'detailedDescription': 'Traumatic brain injury has high morbidity,disability and mortality ; worldwide, more than 50 million new cases , mainly low and middle-income countries.The annual incidence of craniocerebral trauma in China is (55 - 64) / 100000 , with 770 - 890 thousand new cases,causing nearly 100000 deaths and hundreds of thousands of disabilities , which is a serious public safety problem .Injury mechanisms after traumatic brain injury include primary and secondary brain injury and have a lack of effective treatment .Brain edema is one of the main mechanisms of secondary brain injury and one factor in the prognosis of traumatic brain injury .In recent years , the Sur1-Trpm4 channel was found to play an important role in the onset of brain edema , with increased expression in traumatic brain injury , ischemic stroke , and ischemic and hypoxic encephalopathy , and the specific inhibitor glibenclamide can reduce brain edema .A clinical study of glibenclamide in the treatment of brain edema after traumatic brain injury 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 .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Closed craniocerebral trauma;\n2. The injury time on admission was less than 10 hours;\n3. The GCS score was less than 9, and the GCS score was evaluated without sedation or using muscle relaxants;\n4. They were 18-75 years old;\n5. Authorized close relatives to sign informed consent.\n\nExclusion Criteria:\n\n1. The damage time is uncertain;\n2. Penetrating brain injury;\n3. With spinal cord injury;\n4. Severe and fatal injuries associated with other parts of the body;\n5. Pregnant women or pregnancy test positive;\n6. Lactating women had lactation needs during the study period;\n7. blood suger is lower than 2.8 mmol / L;\n8. Renal insufficiency, history of dialysis treatment, or serum creatinine more than 2.5 mg / dl;\n9. The total bilirubin was more than 1.5 times of the upper limit;\n10. INR was greater than 1.4;\n11. Systolic blood pressure was less than 90 and had no response to fluid resuscitation;\n12. Allergic to sulfonylureas;\n13. There was a history of admission for brain injury, mental or neurological diseases within 3 years before brain injury;\n14. The drug use was restricted due to emergency operation within 8 hours after brain injury;\n15. There was a history of taking antiplatelet drugs, oral anticoagulants or heparin or low molecular weight heparin 72 hours before brain injury;\n16. There was a history of taking sulfonylureas within 30 days before brain injury; 17. There was a history of participating in other drug trials within 30 days before brain injury;\n\n18\\. There was a history of G6PD deficiency; 19. There were clinical conditions that other researchers did not consider to meet the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT05148403', 'briefTitle': 'To Evaluate the Effect of Glibenclamide in Reducing Brain Edema of TBI', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Evaluation of Safety and Efficacy of Glibenclamide in the Treatment of Severe Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'glibenclamide study group1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Glibenclamide was given orally or through nasogastric tube, 1.25 mg every 8 hours for 7 days', 'interventionNames': ['Drug: glibenclamide']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No glibenclamide treatment'}], 'interventions': [{'name': 'glibenclamide', 'type': 'DRUG', 'otherNames': ['encephaledema'], 'description': 'Glibenclamide was given orally or by nasal feeding', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'qing lin', 'role': 'CONTACT', 'email': '13811127173@163.com', 'phone': '13811127173'}], 'facility': 'Beijing Tiantan Hospital Affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'qing lin', 'role': 'CONTACT'}], 'facility': 'Beijing Tongren Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'qing lin', 'role': 'CONTACT', 'email': '13811127173@163.com', 'phone': '13811127173'}], 'overallOfficials': [{'name': 'guangzhi shi, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Guangzhi Shi', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}