Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT06330935
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Effect of Tranexamic Acid on the 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': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2024-02-18', 'studyFirstSubmitQcDate': '2024-03-18', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The early traumatic brain injury-related death in the hospital', 'timeFrame': '24 hour and 48 hour after injury', 'description': '2\\. Decreasing the rate of early head injury-related death (within 24 hour after injury)'}, {'measure': 'The difference between treatment group in the Intracranial haemorrhage growth', 'timeFrame': '24 hour', 'description': 'We will measure intracranial hemorrhage progression at 24 hours in all subjects with intracranial hemorrhage on the initial clinical CT scan'}, {'measure': 'The difference between the treatment groups in the incidence of mortality', 'timeFrame': '28 days', 'description': 'Decreasing the rate of head injury-related death in hospital within 28 days of injury all-cause and cause-specific mortality, disability, vascular occlusive events (myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism)'}], 'secondaryOutcomes': [{'measure': 'Need for neurosurgical management', 'timeFrame': '28 day', 'description': 'Evacuation of acute subdural hematoma,Evacuation of epidural hematoma and Evacuation of traumatic intracerebral hematoma (contusions)'}, {'measure': 'Days in the intensive care unit', 'timeFrame': '28 day', 'description': 'Decreasing days in intensive care unit within 28 day of injury'}, {'measure': 'Need for blood transfusion', 'timeFrame': '48 hour', 'description': 'Decreasing the total amount of blood products transfused in the initial 48 hours following randomization. Blood product transfusion volume will be measured at 24 hours, 48 hours. This will include volume of packed red blood cells, plasma, platelets, and cryoprecipitate in mL/kg.'}, {'measure': 'Adverse events', 'timeFrame': '28 days', 'description': 'Decreasing incidence of seizures, complications and other adverse events'}, {'measure': 'Pediatric Quality of Life (PedsQL)', 'timeFrame': '6 months', 'description': 'Improving the Paediatric Quality of Life (PedsQL) . The PedsQL is a continuous score that ranges from 0-100.'}, {'measure': 'Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds)', 'timeFrame': '6 months', 'description': 'Improving the Pediatric Glasgow Outcome Scale Extended (GOS-E Peds) scores'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'Evaluate the effect of tranexamic acid on mortality in pediatric patients with traumatic brain injury. This could potentially lead to improved treatment protocols and better outcomes for this vulnerable population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age Less than 18 years old\n2. Clinical diagnose of trauma to the Head and GCS score less than or equal to 13 with associated intracranial haemorrhage on cranial CT scan\n3. Time of admission within 3 hour of injury.\n\nExclusion Criteria:\n\n1. Patient Known pregnancy.\n2. patient had Cardiac arrest prior to randomization\n3. GCS score of 3 with bilateral unresponsive pupils\n4. Known bleeding/clotting disorders.\n5. Known seizure disorders.\n6. Known history of severe renal impairment\n7. Unknown time of injury\n8. Prior TXA for current injury\n9. Known venous or arterial thrombosis'}, 'identificationModule': {'nctId': 'NCT06330935', 'briefTitle': 'Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Patients With Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Clinical Trial Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Pediatric Patients With Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '192-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TXA dose A arm', 'description': 'Subjects will receive a 15 mg/kg bolus of Tranexamic acid over 20 minutes followed by 2 mg/kg/hr. infusion over 8 hours. The maximum bolus dose is 1000 mg, the maximum rate of infusion is 50 mg/min, and the maximum total maintenance dose is 1000 mg', 'interventionNames': ['Drug: Tranexamic Acid (TXA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TXA dose B arm', 'description': 'Subjects will receive a 30 mg/kg bolus of Tranexamic acid over 20 minutes followed by 4 mg/kg/hr. infusion over 8 hours. The maximum bolus dose is 2000 mg, the maximum rate of infusion is 100 mg/min, and the maximum total maintenance dose is 2000 mg', 'interventionNames': ['Drug: Tranexamic Acid (TXA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm C', 'description': 'Subjects in the placebo group will receive a bolus dose of normal saline over 20 minutes followed by a normal saline infusion over 8 hours (in the same weight-based volume as the other study arms)', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Tranexamic Acid (TXA)', 'type': 'DRUG', 'otherNames': ['TXA dose A arm &TXA dose B arm'], 'description': '30 patients will be randomized to A arm and 30 patients to B arm', 'armGroupLabels': ['TXA dose A arm', 'TXA dose B arm']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['Placebo arm C'], 'description': '30 patients will be randomized this arm C', 'armGroupLabels': ['Placebo arm C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damietta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Adel Diab, professor', 'role': 'CONTACT'}], 'facility': 'Al-Azhar University Hospital in New Damietta', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}], 'centralContacts': [{'name': 'Mohamed Shams, Professor', 'role': 'CONTACT', 'email': 'hamspharma@gmail.comms', 'phone': '201556300563'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy- Faculty of Pharmacy - Mansoura University', 'investigatorFullName': 'Noha Mansour', 'investigatorAffiliation': 'Mansoura University'}}}}