Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT06836856
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury
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': 'D011433', 'term': 'Propranolol'}, {'id': 'D000077261', 'term': 'Carvedilol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of In-hospital mortality', 'timeFrame': '14 days', 'description': 'Difference between the study grous in terms of the percentage of all-cause mortality at the end of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TBI Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'Propranolol primarily acts as a non-selective beta blocker, blocking both beta-1 and beta-2 adrenergic receptors, while carvedilol exhibits a broader spectrum of action by also blocking alpha-1 adrenergic receptors. The receptor blockade profile of a beta blocker can influence its physiological effects and potential therapeutic benefits in TBI. Therefore, the variation in receptor selectivity may result in differences in their impact on secondary brain injury processes and patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patients with moderate \\& severe TBI detected on admission by CT scan and GCS score of ≤ 13 who either do not have any other injuries or only have associated minor injuries.\n\nMinor injuries are defined as presence of any of the following:\n\n1. Mild intraperitoneal free fluid (IPFF) observed through abdominal ultrasound.\n2. mild lung contusion detected in the chest CT scan.\n3. hemothorax or pneumothorax present without accompanying symptoms of hypoxia, tachypnea, or respiratory distress.\n4. simple limb fractures.\n\nExclusion Criteria:\n\n1. Patients on pre-injury beta-blocker therapy.\n2. Patients with any bronchospastic conditions.\n3. Patients with active acute coronary syndrome.\n4. TBI with GCS ≤ 13 with associated major injuries defined as the presence of any of the following:\n\n 1. Moderate \\& marked IPFF requiring surgical intervention ( laparotomy ).\n 2. moderate \\& marked lung contusion, pneumothorax \\& hemothorax with accompanying symptoms of hypoxia, tachypnea, lower limbs, or limb amputation.\n 3. Compound fracture in the upper or lower limb.\n 4. Open Faciomaxillary trauma.\n5. Patients with persistent shock (systemic blood pressure \\<100 mmHg, base deficit \\> 4, or oliguria , HR \\< 60 b/min ) after \\> one week of admission.'}, 'identificationModule': {'nctId': 'NCT06836856', 'briefTitle': 'Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '2024-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm', 'interventionNames': ['Drug: control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'propranolol', 'description': 'propranolol', 'interventionNames': ['Drug: propranolol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'carvedilol', 'description': 'Carvid (carvedilol)', 'interventionNames': ['Drug: Carvedilol']}], 'interventions': [{'name': 'control', 'type': 'DRUG', 'description': 'Patients will receive standard care with no interventions until end of treatment.', 'armGroupLabels': ['Control Arm']}, {'name': 'propranolol', 'type': 'DRUG', 'description': 'starting at 20mg propranolol three times daily by mouth or per feeding tube. The dose was increased daily in 20mg three times daily increments (60mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 640mg/day in addition to standard care until end of treatment.', 'armGroupLabels': ['propranolol']}, {'name': 'Carvedilol', 'type': 'DRUG', 'description': 'starting at 6.25mg carvedilol three times daily by mouth or per feeding tube. The dose was increased daily in 6.25 mg three times daily increments (18.75 mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 100 mg/day in addition to standard care until end of treatment.', 'armGroupLabels': ['carvedilol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Zagazig University Hospitals, Zagazig,', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}, {'city': 'Zagazig', 'status': 'NOT_YET_RECRUITING', 'country': 'Egypt', 'facility': 'Zagazig University Hospitals', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'centralContacts': [{'name': 'Aya Osama Nagaty', 'role': 'CONTACT', 'email': 'doctoraya_15@yahoo.com', 'phone': '00201097721011'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Profesor', 'investigatorFullName': 'Noha Mansour', 'investigatorAffiliation': 'Mansoura University'}}}}