Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-11 @ 4:15 AM
Study NCT ID:
NCT03074994
Status:
UNKNOWN
Last Update Posted:
2019-04-24
First Post:
2016-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2016-11-20', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline hemoglobin concentrations', 'timeFrame': '48 hours after the operation'}, {'measure': 'Unit of blood transfusion', 'timeFrame': '48 hours after the operation'}], 'secondaryOutcomes': [{'measure': 'Tranexamic acid level in blood', 'timeFrame': '2 and 24 hours after the operation'}, {'measure': 'Knee diameter for swelling', 'timeFrame': '24 and 48 hours after the operation'}, {'measure': 'Local soft tissue complications', 'timeFrame': '14 days after the operation'}, {'measure': 'Skin necrosis', 'timeFrame': '24 and 48 hours after the operation'}, {'measure': 'Number of patient with venous thromboembolism', 'timeFrame': '14 days after the operation'}, {'measure': 'Visual Analogue Scales', 'timeFrame': '24 and 48 hours after the operation', 'description': '(VAS, 0 = no pain, 10 = the worst imaginable pain)'}, {'measure': 'Knee flexion angle', 'timeFrame': '24 and 48 hours after the operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tranexamic acid', 'Peri-articular injection', 'Intraarticular injection', 'Total knee arthroplasty', 'Blood loss'], 'conditions': ['Osteoarthritis,Knee']}, 'referencesModule': {'references': [{'pmid': '15486006', 'type': 'RESULT', 'citation': 'Madjdpour C, Spahn DR. Allogeneic red blood cell transfusions: efficacy, risks, alternatives and indications. Br J Anaesth. 2005 Jul;95(1):33-42. doi: 10.1093/bja/aeh290. Epub 2004 Oct 14.'}, {'pmid': '9917695', 'type': 'RESULT', 'citation': 'Fiebig E. Safety of the blood supply. Clin Orthop Relat Res. 1998 Dec;(357):6-18. doi: 10.1097/00003086-199812000-00003.'}, {'pmid': '8236418', 'type': 'RESULT', 'citation': 'Heddle NM, Klama LN, Griffith L, Roberts R, Shukla G, Kelton JG. A prospective study to identify the risk factors associated with acute reactions to platelet and red cell transfusions. Transfusion. 1993 Oct;33(10):794-7. doi: 10.1046/j.1537-2995.1993.331094054613.x.'}, {'pmid': '11251132', 'type': 'RESULT', 'citation': 'Juelsgaard P, Larsen UT, Sorensen JV, Madsen F, Soballe K. Hypotensive epidural anesthesia in total knee replacement without tourniquet: reduced blood loss and transfusion. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):105-10. doi: 10.1053/rapm.2001.21094.'}, {'pmid': '22827564', 'type': 'RESULT', 'citation': 'Sharma V, Fan J, Jerath A, Pang KS, Bojko B, Pawliszyn J, Karski JM, Yau T, McCluskey S, Wasowicz M. Pharmacokinetics of tranexamic acid in patients undergoing cardiac surgery with use of cardiopulmonary bypass. Anaesthesia. 2012 Nov;67(11):1242-50. doi: 10.1111/j.1365-2044.2012.07266.x. Epub 2012 Jul 24.'}, {'pmid': '22161917', 'type': 'RESULT', 'citation': 'Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br. 2011 Dec;93(12):1577-85. doi: 10.1302/0301-620X.93B12.26989.'}, {'pmid': '22623147', 'type': 'RESULT', 'citation': 'Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873.'}, {'pmid': '22065294', 'type': 'RESULT', 'citation': 'Zhang H, Chen J, Chen F, Que W. The effect of tranexamic acid on blood loss and use of blood products in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2012 Sep;20(9):1742-52. doi: 10.1007/s00167-011-1754-z. Epub 2011 Nov 8.'}, {'pmid': '14601276', 'type': 'RESULT', 'citation': 'Ho KM, Ismail H. Use of intravenous tranexamic acid to reduce allogeneic blood transfusion in total hip and knee arthroplasty: a meta-analysis. Anaesth Intensive Care. 2003 Oct;31(5):529-37. doi: 10.1177/0310057X0303100507.'}, {'pmid': '23815893', 'type': 'RESULT', 'citation': 'Panteli M, Papakostidis C, Dahabreh Z, Giannoudis PV. Topical tranexamic acid in total knee replacement: a systematic review and meta-analysis. Knee. 2013 Oct;20(5):300-9. doi: 10.1016/j.knee.2013.05.014. Epub 2013 Jun 28.'}, {'pmid': '25450009', 'type': 'RESULT', 'citation': 'Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23.'}, {'pmid': '21048170', 'type': 'RESULT', 'citation': 'Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.'}, {'pmid': '26507526', 'type': 'RESULT', 'citation': 'Jain NP, Nisthane PP, Shah NA. Combined Administration of Systemic and Topical Tranexamic Acid for Total Knee Arthroplasty: Can It Be a Better Regimen and Yet Safe? A Randomized Controlled Trial. J Arthroplasty. 2016 Feb;31(2):542-7. doi: 10.1016/j.arth.2015.09.029. Epub 2015 Sep 26.'}, {'pmid': '23886406', 'type': 'RESULT', 'citation': 'Konig G, Hamlin BR, Waters JH. Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty. J Arthroplasty. 2013 Oct;28(9):1473-6. doi: 10.1016/j.arth.2013.06.011. Epub 2013 Jul 23.'}, {'pmid': '23881695', 'type': 'RESULT', 'citation': 'Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;2013(7):CD010562. doi: 10.1002/14651858.CD010562.pub2.'}, {'pmid': '27099820', 'type': 'RESULT', 'citation': 'Winter SF, Santaguida C, Wong J, Fehlings MG. Systemic and Topical Use of Tranexamic Acid in Spinal Surgery: A Systematic Review. Global Spine J. 2016 May;6(3):284-95. doi: 10.1055/s-0035-1563609. Epub 2015 Sep 21.'}, {'pmid': '27455842', 'type': 'RESULT', 'citation': 'Pinsornsak P, Rojanavijitkul S, Chumchuen S. Peri-articular tranexamic acid injection in total knee arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2016 Jul 26;17:313. doi: 10.1186/s12891-016-1176-7.'}, {'pmid': '15991130', 'type': 'RESULT', 'citation': "Callaghan JJ, O'Rourke MR, Liu SS. Blood management: issues and options. J Arthroplasty. 2005 Jun;20(4 Suppl 2):51-4. doi: 10.1016/j.arth.2005.03.018."}, {'pmid': '26583092', 'type': 'RESULT', 'citation': 'Sa-ngasoongsong P, Chanplakorn P, Wongsak S, Uthadorn K, Panpikoon T, Jittorntam P, Aryurachai K, Angchaisukisiri P, Kawinwonggowit V. An In Vivo Study of Low-Dose Intra-Articular Tranexamic Acid Application with Prolonged Clamping Drain Method in Total Knee Replacement: Clinical Efficacy and Safety. Biomed Res Int. 2015;2015:164206. doi: 10.1155/2015/164206. Epub 2015 Oct 25.'}, {'pmid': '24385043', 'type': 'RESULT', 'citation': 'Chang CH, Chang Y, Chen DW, Ueng SW, Lee MS. Topical tranexamic acid reduces blood loss and transfusion rates associated with primary total hip arthroplasty. Clin Orthop Relat Res. 2014 May;472(5):1552-7. doi: 10.1007/s11999-013-3446-0. Epub 2014 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'Post-operative bleeding in total knee arthroplasty (TKA) can result in hypovolemic shock and unnecessity for allogenic blood transfusions. Intravenous and topical tranexamic acid (TXA) have been well established in reducing blood loss postoperatively. However, there are lack of data on peri-articular TXA injection during TKA. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial to compare the effectiveness of bleeding reduction of peri-articular TXA injections, intraarticular TXA injections and control group.', 'detailedDescription': "Patients scheduled for unilateral primary TKA; 108 patients were randomly assigned to receive peri-articular TXA, intraarticular TXA and control group. 36 patients received either: (I) 15 mg/kg peri-articular TXA combined with multimodal local anesthetic infiltration (bupivacaine, morphine, ketorolac and epinephrine) into the anterior soft tissue, medial gutter area, lateral gutter area prior to capsular closure and tourniquet deflation (group 1). (II) 2 g of intraarticular TXA after complete capsular closure just before tourniquet deflation (group 2). (III) Don't receive any route of TXA in control group (group 3). Hemoglobin (Hb) concentrations were measured at 24 and 48 hour, and the number of blood transfusions and knee circumference measurements were recorded. Serum TXA was recorded at 2 and 24 hours after operation. The reviewers were blinded to treatment group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with osteoarthritis in need of a TKA\n\nExclusion Criteria:\n\n* Inflammatory arthritis\n* Post-traumatic arthritis\n* A history of or current venous thromboembolic disease\n* Any underlying disease of haemostasis, cirrhosis, chronic renal failure, patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel)\n* Preoperative hemoglobin \\<10 g/dL or a platelet count \\< 140,000 /uL3\n* Allergy to TXA'}, 'identificationModule': {'nctId': 'NCT03074994', 'briefTitle': 'The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty: A Prospective, Double-Blind Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'MTU-EC-OT-6-063/59'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peri-articular tranexamic acid injection', 'description': 'TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area)', 'interventionNames': ['Drug: Peri-articular TXA (15 mg/kg)', 'Procedure: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area']}, {'type': 'EXPERIMENTAL', 'label': 'Intraarticular tranexamic acid injection', 'description': 'TXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration', 'interventionNames': ['Drug: Intraarticular TXA 2 g (40 mL)', 'Procedure: TXA 40 mL inject into intraaricular knee capsule']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "Don't receive any route of TXA"}], 'interventions': [{'name': 'Peri-articular TXA (15 mg/kg)', 'type': 'DRUG', 'description': 'combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL', 'armGroupLabels': ['Peri-articular tranexamic acid injection']}, {'name': 'Intraarticular TXA 2 g (40 mL)', 'type': 'DRUG', 'description': 'inject separate from multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 75 mL)', 'armGroupLabels': ['Intraarticular tranexamic acid injection']}, {'name': 'TXA combined with multimodal local anesthetic infiltration inject into peri-articular area', 'type': 'PROCEDURE', 'description': '(Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation', 'armGroupLabels': ['Peri-articular tranexamic acid injection']}, {'name': 'TXA 40 mL inject into intraaricular knee capsule', 'type': 'PROCEDURE', 'description': 'after multimodal local anesthetic infiltration (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to tourniquet deflation', 'armGroupLabels': ['Intraarticular tranexamic acid injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12120', 'city': 'Pathum Thani', 'state': 'Klongluang', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Piya Pinsornsak, MD', 'role': 'CONTACT', 'email': 'pinpiya2003@yahoo.com', 'phone': '02-926-9705'}], 'facility': 'Thammasat university hospital', 'geoPoint': {'lat': 14.01346, 'lon': 100.53049}}], 'centralContacts': [{'name': 'Piya Pinsornsak, MD', 'role': 'CONTACT', 'email': 'pinpiya2003@yahoo.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boontanapibul, Krit, M.D.', 'class': 'INDIV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'piya pinsornsak', 'investigatorAffiliation': 'Thammasat University'}}}}