Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-28 @ 2:05 PM
Study NCT ID:
NCT05696951
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2023-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid in Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019106', 'term': 'Postoperative Hemorrhage'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014191', 'term': 'Tranylcypromine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-20', 'studyFirstSubmitDate': '2023-01-08', 'studyFirstSubmitQcDate': '2023-01-20', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect on bleeding in the first one hours postoperatively', 'timeFrame': 'postoperative 1st hours', 'description': 'postoperative bleeding'}], 'secondaryOutcomes': [{'measure': 'effect on bleeding in the first 24 hours postoperatively', 'timeFrame': 'postoperative 24st hours', 'description': 'The effect of tranexamic acid on early postoperative bleeding'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tranexamic acid', 'Sleeve gastrectomy', 'Postoperative bleeding'], 'conditions': ['Tranexamic Acid Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '37857939', 'type': 'DERIVED', 'citation': 'Sermet M, Ozsoy MS. Effect of Tranexamic Acid on Postoperative Bleeding in Sleeve Gastrectomy: a Randomized Trial. Obes Surg. 2023 Dec;33(12):3962-3970. doi: 10.1007/s11695-023-06902-x. Epub 2023 Oct 19.'}]}, 'descriptionModule': {'briefSummary': 'The effectiveness of Tranexamic acid use will be measured in cases of sleeve gastrectomy in bariatric surgery and in early postoperative bleeding.', 'detailedDescription': 'Prospective, comparative and double-blind study with patients aged 18-65 years admitted to bariatric surgery. Selected patients were given or not given venous tranexamic acid (TXA) during anesthesia induction (CG). Anesthesia and thromboprophylaxis protocols were similar between groups. For statistical analysis, χ2 and analysis of variance tests were performed using the SPSS 21.0 ® statistical program at a significance level of p \\< 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 to 65 years with an American Association of Anesthesiologists (ASA) physical condition score II or III\n* undergoing bariatric surgery and LSG\n\nExclusion Criteria:\n\n* history of thromboembolic disease or severe comorbidity (ASA IV or more)\n* platelet antiaggregants or anticoagulants\n* active intravascular coagulation carriers\n* acute occlusive vasculopathy\n* hypersensitivity to the components of the TXA formula.'}, 'identificationModule': {'nctId': 'NCT05696951', 'briefTitle': 'Tranexamic Acid in Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Goztepe Prof Dr Suleyman Yalcın City Hospital'}, 'officialTitle': 'Use of Tranexamic Acid in Postoperative Early Period Bleeding in Patients Undergoing Sleeve Gastrectomy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Bnk723'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The effectiveness of Tranexamic acid use of sleeve gastrectomy', 'description': 'In this study, it was determined which treatment package would be received by opening the closed envelopes of patients who had at least one point or more bleeding during the operation and had hemostasis with clips. In the intervention group, at the end of the surgery, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) saline.', 'interventionNames': ['Other: Transamine 200mg iv']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Plasebo grup', 'description': 'The placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours.', 'interventionNames': ['Other: Transamine 200mg iv']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sham grup', 'description': 'Patients with no bleeding to be treated were not enveloped and were excluded from the intervention or placebo group.', 'interventionNames': ['Other: Transamine 200mg iv']}], 'interventions': [{'name': 'Transamine 200mg iv', 'type': 'OTHER', 'description': 'In the intervention group, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes at the end of the surgery. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) SF. The placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours.', 'armGroupLabels': ['Plasebo grup', 'Sham grup', 'The effectiveness of Tranexamic acid use of sleeve gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34732', 'city': 'Kadıköy', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Göztepe Prof. Dr. Suleyman Yalcin City Hospital', 'geoPoint': {'lat': 40.97882, 'lon': 29.08268}}], 'overallOfficials': [{'name': 'medeni şermet, 1', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goztepe Prof Dr Suleyman Yalcın City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goztepe Prof Dr Suleyman Yalcın City Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist Medical doctor', 'investigatorFullName': 'Medeni Şermet', 'investigatorAffiliation': 'Goztepe Prof Dr Suleyman Yalcın City Hospital'}}}}