Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-02 @ 12:38 PM
Study NCT ID:
NCT03540368
Status:
SUSPENDED
Last Update Posted:
2020-08-28
First Post:
2018-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid for The Treatment of Gastrointestinal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-09-24', 'releaseDate': '2020-09-01'}, {'resetDate': '2023-06-29', 'releaseDate': '2022-08-05'}], 'estimatedResultsFirstSubmitDate': '2020-09-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-16', 'size': 1057557, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-05-16T08:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'All patients will receive standard treatment equally'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 336}}, 'statusModule': {'whyStopped': 'increased number of patients death', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-26', 'studyFirstSubmitDate': '2018-05-15', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Re-bleeding', 'timeFrame': '30 days after randomisation', 'description': 'Total incidence number of re-bleeding'}], 'secondaryOutcomes': [{'measure': 'Number of death', 'timeFrame': '30 days after randomisation', 'description': 'Total number patients who die'}, {'measure': 'Need for blood transfusion', 'timeFrame': '30 days after randomisation', 'description': 'Total number of patients with blood transfusion'}, {'measure': 'Length of stay in intensive care unit', 'timeFrame': '30 days after randomisation', 'description': 'Average time of stay each participants in intensive care unit'}, {'measure': 'Need for endoscopic hemostasis', 'timeFrame': '30 days after randomisation', 'description': 'Total number of patients with endoscopic hemostasis'}, {'measure': 'Quality of life (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health)', 'timeFrame': '30 days after randomisation', 'description': 'Short Form-36 Questionnaire includes one scale for each of eight measured health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. All health domain scales are scored using norm-based scores ranging 0 to 100 with higher scores indicate better health'}, {'measure': 'Level of anxiety', 'timeFrame': '30 days after randomisation', 'description': 'Hamilton Anxiety Rating Scale; Each item is scored of 0 (not present) to 4 (severe), with total score range of 0-56, where \\<14 indicates no anxiety, 14-20 mild anxiety, 21-27 moderate anxiety, 28-41 severe anxiety and 42-56 very severe anxiety'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastrointestinal bleeding', 'Tranexamic acid', 'Clinical trial'], 'conditions': ['Gastrointestinal Bleeding']}, 'referencesModule': {'references': [{'pmid': '25414987', 'type': 'BACKGROUND', 'citation': 'Bennett C, Klingenberg SL, Langholz E, Gluud LL. Tranexamic acid for upper gastrointestinal bleeding. Cochrane Database Syst Rev. 2014 Nov 21;2014(11):CD006640. doi: 10.1002/14651858.CD006640.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Studies showed that in cases of gastrointestinal bleeding, injection tranexamic acid decreasing the risk of death and the need of surgical intervention. However, the quality of most clinical trials were not good and the results were not significant. Injection tranexamic acid does not become one of the treatment option in the international guidelines nor in national consensus, so the effectiveness and the safety of its use in the treatment of gastrointestinal bleeding remains unclear and not routinely used.\n\nIn Indonesia, injection tranexamic acid in gastrointestinal bleeding is limitedly used and recorded. Therefore, a clinical trial study of injection tranexamic acid is required to assess the effectiveness and the safety in the treatment of gastrointestinal bleeding.', 'detailedDescription': 'This study is a randomized double-blind controlled trial study. Interventions were given in the form of tranexamic acid injection compared to placebo in patients with acute upper and lower gastrointestinal bleeding. Tranexamic acid were administered intravenously 1 gram loading dose, followed by 3 grams maintenance dose in infusion for 24 hours. Other routine and standardized drugs for gastrointestinal bleeding will still be given. Statistical analysis will use: Chi square test or Kolmogorov-Smirnov with alternative Fisher test for categorical dependent-variable; Independent T-Test with alternative Mann-Whitney test for two-group numerical dependent-variable; and one-way ANOVA with alternative Kruskal-Wallis for more than two-groups numerical dependent-variable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults\n* Patients with acute lower and upper gastrointestinal bleeding (assessed clinically)\n* Patients agreed to participate in the study and signed the informed consent\n\nExclusion Criteria:\n\n* Allergy with tranexamic acid\n* Patients considered by the clinician can not be randomized to participate in the study\n* Patients with chronic kidney disease stage III - V'}, 'identificationModule': {'nctId': 'NCT03540368', 'briefTitle': 'Tranexamic Acid for The Treatment of Gastrointestinal Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Role of Tranexamic Acid for the Treatment of Gastrointestinal Bleeding: A Randomized Double-blind Controlled Trial', 'orgStudyIdInfo': {'id': '18-04-0393'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic acid injection', 'description': 'Group with tranexamic acid injection', 'interventionNames': ['Drug: Tranexamic acid injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Group with Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tranexamic acid injection', 'type': 'DRUG', 'description': 'Administering tranexamic acid loading dose 1 gram in 100 cc sodium chloride 0,9%, followed by maintenance dose 3 grams in infusion for 24 hours.', 'armGroupLabels': ['Tranexamic acid injection']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administering placebo or sodium chloride 0,9% intravenously', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo National Central General Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Ari F Syam, Dr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gastroenterology Division, Internal Medicine Department RSCM/UI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Gastroenterology Hepatology Consultant', 'investigatorFullName': 'Ari Fahrial Syam', 'investigatorAffiliation': 'Indonesia University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-09-01', 'type': 'RELEASE'}, {'date': '2020-09-24', 'type': 'RESET'}, {'date': '2022-08-05', 'type': 'RELEASE'}, {'date': '2023-06-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ari Fahrial Syam, Medical Doctor, Gastroenterology Hepatology Consultant, Indonesia University'}}}}