Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT04785651
Status:
TERMINATED
Last Update Posted:
2025-07-22
First Post:
2021-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'whyStopped': 'Patient enrollment was proceeding slower than planned', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2021-02-16', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative blood loss (haemoglobin balance):', 'timeFrame': 'Basal vs the first post operative day', 'description': 'The perioperative blood loss will be estimated by assessing the haemoglobin balance on the first postoperative day'}], 'secondaryOutcomes': [{'measure': 'Postoperative transfusion rate', 'timeFrame': 'Perioperative time and postoperative time ( up to 60 days)', 'description': 'the percentage of transfusions carried out in the two treatment groups will be determined;'}, {'measure': 'Postoperative blood loss', 'timeFrame': 'Postoperatively (up to 2 days)', 'description': 'The perioperative blood loss will be estimated by assessing the blood loss after surgery (through the volume of blood collected by drainage);'}, {'measure': 'Blood loss after discharge', 'timeFrame': 'at 5 and 15 days post hospital discharge', 'description': 'Post-discharge blood loss will be estimated by assessing haemoglobin balance at 5 and 15 days post-surgery;'}, {'measure': 'International Knee Documentation Committee objective', 'timeFrame': 'Baseline, 30 and 60 days post treatment', 'description': 'The objective rating scale has seven parameters related to knee function. The presence of effusions and degree of knee movement are assessed, the worst value of one of these parameters determines the final IKDC grade. There are four grades (A, B, C, D) that identify a knee assessed as normal, near normal, abnormal and severely abnormal, respectively.'}, {'measure': 'Visual Analogue Scale - Pain', 'timeFrame': 'baseline, 1 day post-treatment, 2 days post-treatment, 1 month, 2 months);', 'description': "visual analogue scale consisting of a straight line segment (10 cm long), the ends of which correspond to 'no pain' and 'strongest pain imaginable'."}, {'measure': 'Soft tissue status', 'timeFrame': 'perioperatively, 30 and 60 days', 'description': 'The condition of the soft tissues (swelling, surgical haematoma, wound distress) will be documented and analysed between the two groups by means of photographic documentation and through the Hollander Wound Evaluation Scales'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tibial osteotomy', 'tranexamic acid'], 'conditions': ['Monocompartimental Tibiofemoral Osteoarthritis', 'Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '25440395', 'type': 'BACKGROUND', 'citation': 'Hunt BJ. The current place of tranexamic acid in the management of bleeding. Anaesthesia. 2015 Jan;70 Suppl 1:50-3, e18. doi: 10.1111/anae.12910.'}, {'pmid': '21512813', 'type': 'BACKGROUND', 'citation': 'Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22.'}, {'pmid': '29939895', 'type': 'BACKGROUND', 'citation': 'Palanisamy JV, Das S, Moon KH, Kim DH, Kim TK. Intravenous Tranexamic Acid Reduces Postoperative Blood Loss After High Tibial Osteotomy. Clin Orthop Relat Res. 2018 Nov;476(11):2148-2154. doi: 10.1097/CORR.0000000000000378.'}]}, 'descriptionModule': {'briefSummary': 'A randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding, pain and wound complications reduction in tibial osteotomies.\n\nAll the 84 included patients will be randomized in one of the two arms, will undergo to a tibial osteotomy and then will prospectively evaluate at different follow ups until 60 days post-surgery', 'detailedDescription': 'Tibial osteotomies represents a well-established treatment option for the medial femorotibial knee arthrosis.\n\nOsteotomy can be performed in minus or in plus, at the latter case with or without interposition of tissue (autologous bone, heterologous bone or bone substitute).\n\nEven though excessive bleeding is not a frequent complication, the blood loss and formation of subcutaneous haematoma can determinate more post-interventional pain, wound suffering and the risk of infections.\n\nTranexamic acid is an antifibrinolytic agent and its use in proximal tibia osteotomies has been retrospectively evaluated in a number of papers, all of which agree on its safety and efficacy in terms of reducing peri-operative bleeding. However, to date there have been no randomised clinical trials demonstrating its superiority in terms of reducing bleeding, subcutaneous haematoma and wound complications in proximal tibia osteotomies.\n\nThis is a randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding , pain and wound complications reduction in tibial osteotomies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients aged between 18 and 70 years;\n2. Single-part tibiofemoral osteoarthritis (K-L 1-3), axial deviation \\> 5°;\n3. Surgical indication for corrective osteotomy;\n4. Isolated osteotomy surgical procedure.\n\nExclusion Criteria:\n\n1. Contraindication criteria for the administration of tranexamic acid, as assessed by the Anaesthesia and Resuscitation specialist during the pre-operative visit. The following will be considered absolute contraindications: epilepsy, thrombophilia and known allergy to the active substance, severe renal insufficiency and acute venous or arterial thrombosis, while the following will be considered relative contraindications: coronary stents in patients who have discontinued treatment with antiplatelet agents and previous deep vein thrombosis;\n2. Known pro-thrombotic conditions (coagulation factor mutations, pregnancy status, previous pulmonary thromboembolism);\n3. BMI \\> 40;\n4. Incapacitated patients;\n5. Patients abusing alcoholic beverages, drugs or medication.\n6. Patients who are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT04785651', 'briefTitle': 'Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies: a Randomised Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'TXA-HTO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic arm', 'description': 'Patients in this arm will undergo to a tibial osteotomy in combination with the anti-fibrinolytic agent Tranexamic acid.', 'interventionNames': ['Drug: Tibial osteotomy with Tranexamic acid']}, {'type': 'OTHER', 'label': 'control arm', 'description': 'Patients in this arm will undergo to a tibial osteotomy without the use of Tranexamic acid', 'interventionNames': ['Procedure: Tibial osteotomy without Tranexamic acid']}], 'interventions': [{'name': 'Tibial osteotomy with Tranexamic acid', 'type': 'DRUG', 'description': 'Patients who will be in the treatment arm after randomisation will receive 100ml saline with a dosage of 20 mg/kg tranexamic acid intravenously at induction. An additional administration of tranexamic acid (10 mg/kg in 100ml intravenous saline) will be given as a booster at the end of the surgical procedure.\n\nAll the patients will undergo to the same tibial osteotomy procedure.', 'armGroupLabels': ['Tranexamic arm']}, {'name': 'Tibial osteotomy without Tranexamic acid', 'type': 'PROCEDURE', 'description': 'Patients in this arm will undergo to the tibial osteotomy procedure as by clinical practice', 'armGroupLabels': ['control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}