Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-03 @ 7:39 AM
Study NCT ID:
NCT03915756
Status:
UNKNOWN
Last Update Posted:
2021-02-15
First Post:
2019-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-12', 'studyFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2019-04-15', 'lastUpdatePostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total RBC loss', 'timeFrame': '96 hours', 'description': 'Total red blood cells loss after surgery'}, {'measure': 'Total RBC loss', 'timeFrame': '24 hours', 'description': 'Total red blood cells loss after surgery'}, {'measure': 'Total RBC loss', 'timeFrame': '1 hour', 'description': 'Total red blood cells loss after surgery'}, {'measure': 'Blood transfusion requirements', 'timeFrame': '96 hours', 'description': 'Blood transfusions requirements'}, {'measure': 'Knee Society Score score', 'timeFrame': '14 days', 'description': 'Knee Society Score measuring function of Knee (0-100 total score, higher values, better outcome)'}], 'secondaryOutcomes': [{'measure': 'Haematocrit level', 'timeFrame': '1 hour', 'description': 'Haematocrit level'}, {'measure': 'Haematocrit level', 'timeFrame': '24 hours', 'description': 'Haematocrit level'}, {'measure': 'Haematocrit level', 'timeFrame': '96 hours', 'description': 'Haematocrit level'}, {'measure': 'Haemoglobin level', 'timeFrame': '1 hour', 'description': 'Haemoglobin level'}, {'measure': 'Haemoglobin level', 'timeFrame': '24 hours', 'description': 'Haemoglobin level'}, {'measure': 'Haemoglobin level', 'timeFrame': '96 hours', 'description': 'Haemoglobin level'}, {'measure': 'Surgery duration', 'timeFrame': '0hour', 'description': 'Surgery duration (min)'}, {'measure': 'Length of skin incision', 'timeFrame': '0 hour', 'description': 'Length of skin incision'}, {'measure': 'Tourniquet duration', 'timeFrame': '0 hour', 'description': 'Tourniquet duration (min)'}, {'measure': 'Surgical blood loss', 'timeFrame': '0 hour', 'description': 'Surgical blood loss (mL)'}, {'measure': 'Iron', 'timeFrame': '96 hours', 'description': 'Iron products used'}, {'measure': 'Transfusion reactions', 'timeFrame': '96 hours', 'description': 'Transfusion reactions'}, {'measure': 'Drain volume', 'timeFrame': '24 hours', 'description': 'Drain volume (mL)'}, {'measure': 'MKC', 'timeFrame': '48 hours', 'description': 'Midpatellar Knee Circumference (cm)'}, {'measure': 'MKC', 'timeFrame': '96 hours', 'description': 'Midpatellar Knee Circumference (cm)'}, {'measure': 'MKC', 'timeFrame': '14 days', 'description': 'Midpatellar Knee Circumference (cm)'}, {'measure': 'ROM', 'timeFrame': '48 hours', 'description': 'Range of motion (°)'}, {'measure': 'ROM', 'timeFrame': '96 hours', 'description': 'Range of motion (°)'}, {'measure': 'ROM', 'timeFrame': '14 days', 'description': 'Range of motion (°)'}, {'measure': 'Fluidotherapy excess', 'timeFrame': '96 hours', 'description': 'Fluidotherapy excess (mL)'}, {'measure': 'Wound complications (i. e., wound dehiscence, infection)', 'timeFrame': '14 days', 'description': 'Wound complications (i. e., wound dehiscence, infection)'}, {'measure': 'Lower leg deep vein thrombosis', 'timeFrame': '14 days', 'description': 'Lower leg deep vein thrombosis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee replacement', 'Blood loss', 'Wound drainage'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '24553908', 'type': 'BACKGROUND', 'citation': 'Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.'}, {'pmid': '15173310', 'type': 'BACKGROUND', 'citation': 'NIH Consensus Panel. NIH Consensus Statement on total knee replacement December 8-10, 2003. J Bone Joint Surg Am. 2004 Jun;86(6):1328-35. doi: 10.2106/00004623-200406000-00031. No abstract available.'}, {'pmid': '24122437', 'type': 'BACKGROUND', 'citation': 'Banerjee S, Kapadia BH, Issa K, McElroy MJ, Khanuja HS, Harwin SF, Mont MA. Postoperative blood loss prevention in total knee arthroplasty. J Knee Surg. 2013 Dec;26(6):395-400. doi: 10.1055/s-0033-1357491. Epub 2013 Oct 11.'}, {'pmid': '26961597', 'type': 'BACKGROUND', 'citation': 'Huang GP, Jia XF, Xiang Z, Ji Y, Wu GY, Tang Y, Li J, Zhang J. Tranexamic Acid Reduces Hidden Blood Loss in Patients Undergoing Total Knee Arthroplasty: A Comparative Study and Meta-Analysis. Med Sci Monit. 2016 Mar 10;22:797-802. doi: 10.12659/msm.895571.'}, {'pmid': '25450009', 'type': 'BACKGROUND', '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': '28658157', 'type': 'BACKGROUND', 'citation': 'Zhang Y, Zhang JW, Wang BH. Efficacy of tranexamic acid plus drain-clamping to reduce blood loss in total knee arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(26):e7363. doi: 10.1097/MD.0000000000007363.'}, {'pmid': '29408472', 'type': 'BACKGROUND', 'citation': 'Liao L, Chen Y, Tang Q, Chen YY, Wang WC. Tranexamic acid plus drain-clamping can reduce blood loss in total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Apr;52:334-341. doi: 10.1016/j.ijsu.2018.01.040. Epub 2018 Feb 3.'}, {'pmid': '23494778', 'type': 'BACKGROUND', 'citation': 'Craik JD, Ei Shafie SA, Kidd AG, Twyman RS. Can local administration of tranexamic acid during total knee arthroplasty reduce blood loss and transfusion requirements in the absence of surgical drains? Eur J Orthop Surg Traumatol. 2014 Apr;24(3):379-84. doi: 10.1007/s00590-013-1206-1. Epub 2013 Mar 14.'}, {'pmid': '24816760', 'type': 'BACKGROUND', 'citation': 'Yang Y, Lv YM, Ding PJ, Li J, Ying-Ze Z. The reduction in blood loss with intra-articular injection of tranexamic acid in unilateral total knee arthroplasty without operative drains: a randomized controlled trial. Eur J Orthop Surg Traumatol. 2015 Jan;25(1):135-9. doi: 10.1007/s00590-014-1461-9. Epub 2014 May 10.'}, {'pmid': '26521781', 'type': 'BACKGROUND', 'citation': 'Gao FQ, Li ZJ, Zhang K, Sun W, Zhang H. Four Methods for Calculating Blood-loss after Total Knee Arthroplasty. Chin Med J (Engl). 2015 Nov 5;128(21):2856-60. doi: 10.4103/0366-6999.168041.'}, {'pmid': '21936146', 'type': 'BACKGROUND', 'citation': 'Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "The investigator's aim with this study is to address, with the new paradigm of tranexamic acid, the role of wound drainage following total knee arthroplasty in blood loss, blood transfusion requirements and functional recovery", 'detailedDescription': "All participants will attend a preoperatory appointment with an anaesthesiologist where preoperative haemoglobin will be optimized (Hg \\> 13 g/L).\n\nRandomization will be done by opening a closed envelop with the selected group from a bag at the time of wound closure.\n\nCollected preoperative information will include age, gender, weight, height, body-mass index, underlying diseases, operated side, haematocrit, haemoglobin level, midpatellar knee circumference and range of movement. Blood work was performed within 1 hour of the beginning of the surgery. Clinical parameters will be collected before anaesthesia.\n\nIn all cases, the surgeon will perform a medial parapatellar approach with a standard incision with the participants in the supine position. The SIGMA PFC total knee system (DePuy, Warsaw, In) and its posterior-stabilized design with a rotatory platform will be used. All participants will be under a subarachnoid spinal block.\n\nA tourniquet will be used (pressure of 350 mmHg) from the beginning of the surgery and deflated for haemostasis before wound closure. At this time, before complete water-tight fascial closure, the patients will be allocated to group With or Without drain as described, and a drain will be placed in a subfascial position. The drain will be left clamped for 1 hour and will be left in place for 24 hours. Compressive dressings will be applied at the end of the surgery. Continuous passive motion will be started within 24 hours of surgery (0-60°, progressing as tolerated).\n\nIn all participants, about 30min before tourniquet release, intravenous tranexamic acid will be used with an initial bolus of 10 mg/kg administered in 10min followed by a perfusion of 10mg/kg over 4h. For postoperative analgesia, a femoral triangle and a popliteal block (anterior approach) will be done in all participants.\n\nA standard fluid therapy of a balanced crystalloid solution (perfusion 10ml/kg/h) will be administered to all patients. After tourniquet release, during haemostasis and in the recovery room, an eventual need of increasing fluid therapy perfusion or a bolus will be noted in the patient's file.\n\nHidden blood loss will be calculated according to the haemoglobin balance method as it suggested to be the most reliable method. Total blood volume will be calculated as described by Nadler et al.\n\nThe normality of the data will be tested with the Shapiro-Wilk test/Kolmogorov-Smirnov test. The data will be compared and analyzed using Student's t-test for independent samples, or the Mann-Whitney test, according to the normality of the data. The correlation of data will be analyzed with the Pearson or Spearman correlation coefficient according to its normality. Nominal variables will be compared using the chi-square test. P-values less than 0.05 will be considered significant. Dedicated statistical software (SPSS version 21, SPSS Inc., Chicago, USA) will be used."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients admitted to perform a primary unilateral total knee arthroplasty\n\nExclusion Criteria:\n\n* Contraindication to take tranexamic acid\n* hematologic disease with a higher risk of bleeding\n* abnormal coagulation tests\n* refusal of blood transfusions\n* inadequate preoperatory optimization\n* deformity \\>15⁰ of varus or valgus'}, 'identificationModule': {'nctId': 'NCT03915756', 'briefTitle': 'Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Beatriz Ângelo'}, 'officialTitle': 'Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid: a Clinical Trial', 'orgStudyIdInfo': {'id': '0389'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With drain', 'description': 'Participants who received a drain during surgery', 'interventionNames': ['Procedure: Drainage of surgical wound']}, {'type': 'NO_INTERVENTION', 'label': 'Without drain', 'description': 'Participants who did not receive a drain during surgery'}], 'interventions': [{'name': 'Drainage of surgical wound', 'type': 'PROCEDURE', 'description': 'Introduction of a drain before full fascial closure', 'armGroupLabels': ['With drain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2674-514', 'city': 'Loures', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Afonso Cardoso', 'role': 'CONTACT', 'email': 'afonso.cardoso@hbeatrizangelo.pt', 'phone': '00351918972882'}], 'facility': 'Hospital Beatriz Angelo', 'geoPoint': {'lat': 38.83091, 'lon': -9.16845}}], 'centralContacts': [{'name': 'Afonso Cardoso', 'role': 'CONTACT', 'email': 'afonso.cardoso@hbeatrizangelo.pt', 'phone': '00351918972882'}], 'overallOfficials': [{'name': 'Afonso Cardoso', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Beatriz Angelo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Beatriz Ângelo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Afonso Cardoso', 'investigatorAffiliation': 'Hospital Beatriz Ângelo'}}}}