Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT06457360
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2023-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Chitosan, Ankaferd and Tranexamic Acid in Dental Extraction in Liver Pre-Transplant Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'C539751', 'term': 'ankaferd blood stopper'}, {'id': 'D048271', 'term': 'Chitosan'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002686', 'term': 'Chitin'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2024-06-09', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases', 'timeFrame': '30 minutes', 'description': 'evaluation of the previous materials which will be the most effective as a hemostatic agent by measuring blood loss after dental extraction after 30 minutes by the weight difference between the gauze preoperatively and postoperatively using fine electronic measurement weight device'}], 'secondaryOutcomes': [{'measure': 'pain score assessment', 'timeFrame': '7 days', 'description': 'Pain scores will be assessed using Visual Analog Scale from 0 to 10 pain score for seven days following extraction where 0 is no pain and 10 is maximum pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is:\n\nTo assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases where the:\n\n• Primary objective: is to evaluate which of the previous materials will be the most effective as a hemostatic agent'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with end stage liver disease that need dental extraction before liver transplant\n2. Patients aged between 4 and 9 years old\n3. Patients having international normalized ratio (INR) values ≤ 4 (i.e. 1-4)\n\nExclusion Criteria:\n\n1. Patients with allergy to sea food because chitosan- based dressing is manufactured from freeze-dried chitosan, derived from shrimp shell.\n2. Patients having genetic bleeding disorders\n3. Patients with renal diseases'}, 'identificationModule': {'nctId': 'NCT06457360', 'briefTitle': 'Comparison of Chitosan, Ankaferd and Tranexamic Acid in Dental Extraction in Liver Pre-Transplant Children', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'Comparative Assessment of Chitosan-Based Dressing, Ankaferd and Tranexamic Acid in Achieving Hemostasis and Healing Following Dental Extraction in Liver Pre-Transplant Children', 'orgStudyIdInfo': {'id': 'PED 20-2D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1 sterile gauze with chitosan', 'description': 'Chitosan-based dressing gauze after extraction in patients with end stage liver disease', 'interventionNames': ['Drug: Chitosan']}, {'type': 'EXPERIMENTAL', 'label': 'group 2 sterile gauze with ankaferd blood stopper', 'description': 'ankaferd blood stopper dressing gauze after extraction in patients with end stage liver disease', 'interventionNames': ['Drug: Ankaferd Blood Stopper']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 3 sterile gauze with tranexamic acid', 'description': 'tranexamic acid dressing gauze after extraction in patients with end stage liver disease', 'interventionNames': ['Drug: tranexamic acid']}], 'interventions': [{'name': 'tranexamic acid', 'type': 'DRUG', 'description': 'Application of sterile gauze after extraction for hemostasis', 'armGroupLabels': ['group 3 sterile gauze with tranexamic acid']}, {'name': 'Ankaferd Blood Stopper', 'type': 'DRUG', 'description': 'Application of sterile gauze after extraction for hemostasis', 'armGroupLabels': ['group 2 sterile gauze with ankaferd blood stopper']}, {'name': 'Chitosan', 'type': 'DRUG', 'description': 'Application of sterile gauze after extraction for hemostasis', 'armGroupLabels': ['group 1 sterile gauze with chitosan']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'British University in Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'noha S Kabil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'British University In Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}