Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT05686005
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2023-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tranexamic Acid in Functional Endoscopic Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-01', 'studyFirstSubmitDate': '2023-01-06', 'studyFirstSubmitQcDate': '2023-01-06', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative field bleeding', 'timeFrame': 'At 30 minutes after surgery start', 'description': 'The Wormald grading system for bleeding during endoscopic sinus surgery (0= no bleeding and 10= severe bleeding with sphenoid fills \\< 10 seconds)'}], 'secondaryOutcomes': [{'measure': 'Incidence of the common adverse effects', 'timeFrame': 'At 24 hours', 'description': 'Postoperative nasal bleeding, nausea, and vomiting.'}, {'measure': 'Post operative D-dimer', 'timeFrame': 'At 24 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the effect of oral tranexamic acid vs. intravenous in decreasing bleeding and improving the field during FESS.', 'detailedDescription': 'The use of tranexamic acid during Intraoperative bleeding in functional endoscopic sinus surgery (FESS) improves the outcome. Bleeding is one of the most devastating complications during fess. Tranexamic acid is used in open heart surgery to improve the surgical field.\n\nUsing oral vs. intravenous forms of the drug will add to our knowledge and improve outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists grade I or II.\n* Sex: Both sexes.\n* Age between 18 and 40 years.\n* Patients scheduled for FESS under general anesthesia.\n\nExclusion Criteria:\n\n* Declining to give written informed consent.\n* History of allergy to the medications used in the study.\n* History of venous or arterial thrombosis.\n* history of cardiovascular diseases including AF, IHD, or hypertension.\n* History of chest problems including pulmonary embolism, bronchial asthma and COPD.\n* History of cerebrovascular stroke.\n* History of drug or alcohol abuse.\n* Taking opioids or sedative medications.\n* Hepatic or renal failure.\n* Bleeding disorders, antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).'}, 'identificationModule': {'nctId': 'NCT05686005', 'briefTitle': 'Tranexamic Acid in Functional Endoscopic Sinus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Efficacy of Oral Versus Intravenous Tranexamic Acid in Functional Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.', 'orgStudyIdInfo': {'id': 'FMASU R 237/ 2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral tranexamic', 'description': 'The participants will receive 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.', 'interventionNames': ['Drug: Oral tranexamic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous tranexamic', 'description': 'The participants will receive 15 mg/kg in a 20ml syringe slowly tranexamic acid during induction.', 'interventionNames': ['Drug: Intravenous tranexamic acid']}], 'interventions': [{'name': 'Oral tranexamic acid', 'type': 'DRUG', 'description': '4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.', 'armGroupLabels': ['Oral tranexamic']}, {'name': 'Intravenous tranexamic acid', 'type': 'DRUG', 'description': '15mg/kg of tranexamic acid in a 20ml syringe slowly intravenous during induction.', 'armGroupLabels': ['Intravenous tranexamic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'faculty of medicine, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia', 'investigatorFullName': 'Tamer Samir Abdelsalam', 'investigatorAffiliation': 'Ain Shams University'}}}}