Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-30 @ 10:24 AM
Study NCT ID:
NCT05464394
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2022-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1524}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2022-07-12', 'studyFirstSubmitQcDate': '2022-07-15', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 're-intervention rate', 'timeFrame': '30 days', 'description': 'To compare the re-intervention rate due to haemorrhage within 30 days postoperative, after peroperative administration of TXA versus placebo in patients receiving a RYGB or OAGB'}], 'secondaryOutcomes': [{'measure': 'the use of haemostatic staple devices', 'timeFrame': 'peroperatively', 'description': 'measurement (yes/no). Peroperatively, only on active bleeding a heamostatic staple device will be used. If there is no bleeding no haemostatic staple device will be used.'}, {'measure': 'the use of fibrin sealant', 'timeFrame': 'peroperatively', 'description': 'measurement (yes/no). Peroperatively, if the staple line is not actively bleeding but is oozing, fibrin sealant is used. If there is no oozing, fibrin sealant is not used.'}, {'measure': 'blood loss', 'timeFrame': 'peroperatively', 'description': 'blood loss in ml during surgery'}, {'measure': 'haemoglobin decrease', 'timeFrame': '1 day', 'description': 'haemoglobin decrease postoperative'}, {'measure': 'heart rate increase', 'timeFrame': '1 day', 'description': 'heart rate increase postoperative'}, {'measure': 'number of suspicion on haemorrhage', 'timeFrame': '30 days', 'description': 'number of suspicion on haemorrhage for which extra haemoglobin monitoring'}, {'measure': 'number of suspicion on haemorrhage for which extra haemoglobin monitoring', 'timeFrame': '30 days', 'description': 'number of suspicion on haemorrhage for which extra haemoglobin monitoring'}, {'measure': 'VTE', 'timeFrame': '30 days', 'description': 'VTE postoperative'}, {'measure': 'complications rates', 'timeFrame': '30 days', 'description': 'postoperative complications rates'}, {'measure': 'length of hospital stay', 'timeFrame': '30 days', 'description': 'length of hospital stay'}, {'measure': 'duration of primary surgery', 'timeFrame': '1 day', 'description': 'duration of primary surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric bypass', 'Tranexamic acid'], 'conditions': ['Hemorrhage', 'Bleeding']}, 'referencesModule': {'references': [{'pmid': '38719323', 'type': 'DERIVED', 'citation': "'t Hart JWH, Noordman BJ, Palsgraaf-Huisbrink J, Dunkelgrun M, Zengerink HF, Birnie E, van Det MJ, Boerma EG, de Castro SMM, Hazebroek EJ, Langenhoff BS, Verhoef C, Apers JA. Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial). BMJ Open. 2024 May 6;14(5):e078853. doi: 10.1136/bmjopen-2023-078853."}]}, 'descriptionModule': {'briefSummary': 'The incidence of bleeding after metabolic surgery seems to increase. The administration of a drug (tranexamic acid) that can reduce bleeding could possibly also reduce bleeding after metabolic surgery.\n\nObjective: This study aims to determine whether administration of tranexamic acid before surgery can reduce postoperative bleeding in patients undergoing gastric bypass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary metabolic procedure;\n* Gastric bypass: Roux-en-Y gastric bypass or One-anastomoses gastric bypass;\n* ≥18 years;\n* Good command of the Dutch or English language.\n\nExclusion Criteria:\n\n* Patients unwilling to give informed consent;\n* Patients with a medical history of bleeding or VTE (defined as, pulmonary embolism (PE) or deep vein thrombosis (DVT));\n* Patients who use anticoagulants;\n* Arterial bleeding or (iatrogenic) bleeding during the procedure coming from surrounding organs or vascular structures such as the liver or the spleen.'}, 'identificationModule': {'nctId': 'NCT05464394', 'acronym': 'PATRY', 'briefTitle': 'Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Franciscus Gasthuis'}, 'officialTitle': 'Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass to Reduce Haemorrhage (PATRY Study): a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2022-031'}, 'secondaryIdInfos': [{'id': '2022-001384-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic acid', 'description': '1500mg Tranexamic acid', 'interventionNames': ['Drug: Tranexamic Acid Injection [Cyklokapron]']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'sodium chloride', 'interventionNames': ['Drug: Sodium chloride 0.9%']}], 'interventions': [{'name': 'Tranexamic Acid Injection [Cyklokapron]', 'type': 'DRUG', 'description': 'A set dose of 1500 mg will be used, based on the study population with morbid obesity. It will be administered intravenous dissolved in 100 ml sodium chloride 0.9% in a time frame of 15-30 minutes, with a maximum of 100 mg/min.', 'armGroupLabels': ['Tranexamic acid']}, {'name': 'Sodium chloride 0.9%', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': '100 ml sodium chloride 0.9% will be administered in a time frame of 15-30 minutes', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Judith WH Hart, MD', 'role': 'CONTACT', 'email': 'j.hart@franciscus.nl', 'phone': '010 - 461 6163', 'phoneExt': '+31'}, {'name': 'Jan A Apers, MD', 'role': 'CONTACT', 'email': 'j.apers@franciscus.nl', 'phone': '010 - 461 6163', 'phoneExt': '+31'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Participant-level data, protocols, and the statistical analysis plan will be available upon reasonable request at publication. Within 1 year after the last follow-up.', 'ipdSharing': 'YES', 'description': 'Data Statement: The identified individual clinical trial participant-level data, protocols, and the statistical analysis plan will be available upon reasonable request at publication. These data will be available for researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to j.apers@franciscus.nl, and to obtain access, data requestors will need a data access agreement.', 'accessCriteria': 'upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Franciscus Gasthuis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}