Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-03-04 @ 12:45 AM
Study NCT ID:
NCT00994994
Status:
COMPLETED
Last Update Posted:
2009-10-14
First Post:
2009-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid in Pediatric Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D014191', 'term': 'Tranylcypromine'}, {'id': 'D000933', 'term': 'Antifibrinolytic Agents'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D050299', 'term': 'Fibrin Modulating Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D006490', 'term': 'Hemostatics'}, {'id': 'D003029', 'term': 'Coagulants'}, {'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-13', 'studyFirstSubmitDate': '2009-10-13', 'studyFirstSubmitQcDate': '2009-10-13', 'lastUpdatePostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery', 'timeFrame': '24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'blood loss 6 hours after surgery', 'timeFrame': '6 hours after surgery'}, {'measure': 'the amount of blood transfusion', 'timeFrame': '24 hour after surgery'}, {'measure': 'additional TXA administration', 'timeFrame': '24 hours after surgery'}, {'measure': 'chest closure time (protamine to skin closure)', 'timeFrame': 'at the end of surgery'}, {'measure': 're-exploration of chest for excess bleeding', 'timeFrame': 'within 24 hours after surgery'}, {'measure': 'duration of mechanical ventilation', 'timeFrame': 'at the time of extubation'}, {'measure': 'length of stay in intensive care unit', 'timeFrame': 'at the time of discharge from ICU'}, {'measure': 'episode of thrombotic complication', 'timeFrame': 'from drug administration to hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pediatric cardiac surgery', 'bleeding', 'tranexamic acid', 'fibrinolysis', 'blood loss in pediatric cardiac surgery'], 'conditions': ['Blood Loss', 'Congenital Heart Disease']}, 'referencesModule': {'references': [{'pmid': '21947753', 'type': 'DERIVED', 'citation': 'Shimizu K, Toda Y, Iwasaki T, Takeuchi M, Morimatsu H, Egi M, Suemori T, Suzuki S, Morita K, Sano S. Effect of tranexamic acid on blood loss in pediatric cardiac surgery: a randomized trial. J Anesth. 2011 Dec;25(6):823-30. doi: 10.1007/s00540-011-1235-z. Epub 2011 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric cardiac surgery with well balanced patients population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children undergoing elective cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* neonate born within 1 month\n* preoperative inotropes\n* preoperative mechanical ventilation\n* preexisting coagulation disorder\n* reoperation within 48 hours\n* significant liver or kidney disease\n* known allergy to TXA'}, 'identificationModule': {'nctId': 'NCT00994994', 'acronym': 'TXA', 'briefTitle': 'Tranexamic Acid in Pediatric Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Okayama University'}, 'officialTitle': 'Tranexamic Acid Reduces Blood Loss in Pediatric Cardiac Surgery', 'orgStudyIdInfo': {'id': 'Ped Txa Cya'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic acid', 'description': '50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit.', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'same volume of normal saline was given.', 'interventionNames': ['Drug: Tranexamic Acid']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'otherNames': ['transamine', 'antifibrinolytic', 'lysin analogue'], 'description': '50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit in TXA group. same volume of normal saline was given in Placebo group.', 'armGroupLabels': ['Placebo', 'Tranexamic acid']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yuichiro Toda, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Intensive Care, Okayama University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Okayama University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yuichiro Toda', 'oldOrganization': 'Dept. of Anesthesiology, Okayama University Hospital'}}}}