Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-25 @ 7:20 PM
Study NCT ID:
NCT02335359
Status:
COMPLETED
Last Update Posted:
2019-05-14
First Post:
2015-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid in Major Vascular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-12', 'studyFirstSubmitDate': '2015-01-07', 'studyFirstSubmitQcDate': '2015-01-08', 'lastUpdatePostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss (milliliters)', 'timeFrame': 'intraoperative (from skin incision to skin closure)'}], 'secondaryOutcomes': [{'measure': 'Number of packed blood red cells transfused', 'timeFrame': 'hospital stay (an average of one week)'}, {'measure': 'Occurrence of thromboembolic events (of any nature)', 'timeFrame': '28-days and one year after surgery'}, {'measure': 'Mortality', 'timeFrame': '28-days and one year after surgery'}]}, 'conditionsModule': {'conditions': ['Blood Loss, Surgical']}, 'referencesModule': {'references': [{'pmid': '31607387', 'type': 'DERIVED', 'citation': 'Monaco F, Nardelli P, Pasin L, Barucco G, Mattioli C, Di Tomasso N, Dalessandro G, Giardina G, Landoni G, Chiesa R, Zangrillo A. Tranexamic acid in open aortic aneurysm surgery: a randomised clinical trial. Br J Anaesth. 2020 Jan;124(1):35-43. doi: 10.1016/j.bja.2019.08.028. Epub 2019 Oct 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 50\n* Able to give written informed consent\n* Undergoing open abdominal aortic aneurysm repair\n\nExclusion Criteria:\n\n* Patients participating in a pharmaceutical clinical trial in the last 3 months\n* Urgent/emergent surgery\n* Allergy/intolerance to tranexamic acid\n* History of seizures\n* Acute Venous or Arterial Thrombosis\n* Fibrinolytic conditions due to consumption coagulopathy\n* Disseminated intravascular coagulation\n* Haematuria\n* Visual disturbances'}, 'identificationModule': {'nctId': 'NCT02335359', 'briefTitle': 'Tranexamic Acid in Major Vascular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Tranexamic Acid in Major Vascular Surgery. A Randomized Placebo-controlled Trial.', 'orgStudyIdInfo': {'id': 'Tranex-AAA/34/OSR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic Acid', 'description': 'A 500 mg loading dose of tranexamic acid diluted in 100 ml of saline solution will be slowly administered intravenously to patients 20 minutes before surgery, followed by a continuos infusion of 250 mg/h of tranexamic acid from surgical incision until skin closure.', 'interventionNames': ['Drug: tranexamic acid diluted in 100 ml of saline solution (loading dose)', 'Drug: tranexamic acid undiluted (continous infusion)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'tranexamic acid diluted in 100 ml of saline solution (loading dose)', 'type': 'DRUG', 'armGroupLabels': ['Tranexamic Acid']}, {'name': 'tranexamic acid undiluted (continous infusion)', 'type': 'DRUG', 'armGroupLabels': ['Tranexamic Acid']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Laura Pasin', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}