Comparison of Topical and Infusion Tranexamic Acid After Total Knee Arthroplasty
NCT ID: NCT02453802
Last Updated: 2015-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2015-06-30
2016-05-31
Brief Summary
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Detailed Description
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Because of this concern, recently, there were few reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients. However, most of the reports compared the topical TXA with placebo in TKA patients, not with intravenous TXA. Recently, Georgiadis et al. conducted a double-blind, randomized controlled clinical trial are demonstrated similar transfusion rate and perioperative blood loss between topical administration and intravenous injection of TXA in TKA patients. There were no significant safety differences between the two groups. Low-molecular weight heparin (LMWH) was used for thromboembolism prophylaxis in that study.
Recently, chemical VTE prophylaxis such as rivaroxaban has been approved as a standard care after TKA because of its superior convenience and efficacy on VTE prophylaxis to LMWH in TKAs. However, because of direct blockage of the formation of thrombin from prothrombin by rivaroxaban, an increased postoperative bleeding has been reported. There have been little studies investigating the blood-conservation effect of TXA on TKA patients either by infusion or by topical application when rivaroxaban used as VTE prophylaxis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Topic TXA group
Primary total knee replacement with intravenous 0.9% normal saline (20 ml) administration before deflation of the tourniquet and intraarticular application of Tranexamic Acid 5%,5ml/amp 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
Tranexamic Acid 5%,5ml/amp
Intraarticular application of tranexamic acid 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule
rivaroxaban (10mg)
Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.
0.9% Normal Saline
Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet
IV TXA group
Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously before deflection of the tourniquet and topical 160 ml 0.9% normal saline application after closure of joint capsule.
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
Tranexamic Acid 5%,5ml/amp
IV TXA group: Primary total knee replacement with 1 g tranexamic acid administrated intravenously before deflection of the tourniquet
rivaroxaban (10mg)
Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.
0.9% Normal Saline
Topical 160 ml normal saline application after closure of joint capsule.
Control group
Primary total knee replacement with 0.9% normal saline administration intravenously before deflation of the tourniquet and topical 160 ml 0.9% normal saline application after closure of joint capsule.
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
rivaroxaban (10mg)
Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.
0.9% Normal Saline
Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet
0.9% Normal Saline
Topical 160 ml normal saline application after closure of joint capsule.
Interventions
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Tranexamic Acid 5%,5ml/amp
Intraarticular application of tranexamic acid 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule
Tranexamic Acid 5%,5ml/amp
IV TXA group: Primary total knee replacement with 1 g tranexamic acid administrated intravenously before deflection of the tourniquet
rivaroxaban (10mg)
Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.
0.9% Normal Saline
Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet
0.9% Normal Saline
Topical 160 ml normal saline application after closure of joint capsule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Failure of medical treatment or rehabilitation
* Hemoglobin \> 10g/dl
* No use of non-steroid anti-inflammatory agent one week before operation
Exclusion Criteria
* History of infection or intraarticular fracture of the affective knee
* Renal function deficiency (GFR \< 55 ml/min/1.73m2)which is relative contraindicated for venography
* Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy (including long-term use anticoagulant)
* History of deep vein thrombosis, ischemic heart disease or stroke
50 Years
80 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Wang Jun-Wen
Clinical Professor
Principal Investigators
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Jun-Wen Wang, MD
Role: STUDY_CHAIR
Chang Gung Memorial Hospital
Locations
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Kaohsiung Chang Gung Memorial Hospital
Koahsiung, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1937-44. doi: 10.2106/JBJS.N.00060.
Lin PC, Hsu CH, Chen WS, Wang JW. Does tranexamic acid save blood in minimally invasive total knee arthroplasty? Clin Orthop Relat Res. 2011 Jul;469(7):1995-2002. doi: 10.1007/s11999-011-1789-y. Epub 2011 Feb 1.
Lin PC, Hsu CH, Huang CC, Chen WS, Wang JW. The blood-saving effect of tranexamic acid in minimally invasive total knee replacement: is an additional pre-operative injection effective? J Bone Joint Surg Br. 2012 Jul;94(7):932-6. doi: 10.1302/0301-620X.94B7.28386.
Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1080-3. doi: 10.1016/j.arth.2012.11.016. Epub 2013 Mar 28.
Chimento GF, Huff T, Ochsner JL Jr, Meyer M, Brandner L, Babin S. An evaluation of the use of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):74-7. doi: 10.1016/j.arth.2013.06.037.
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.
Georgiadis AG, Muh SJ, Silverton CD, Weir RM, Laker MW. A prospective double-blind placebo controlled trial of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):78-82. doi: 10.1016/j.arth.2013.03.038. Epub 2013 Jul 29.
Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016.
Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.
Jameson SS, Rymaszewska M, Hui AC, James P, Serrano-Pedraza I, Muller SD. Wound complications following rivaroxaban administration: a multicenter comparison with low-molecular-weight heparins for thromboprophylaxis in lower limb arthroplasty. J Bone Joint Surg Am. 2012 Sep 5;94(17):1554-8. doi: 10.2106/JBJS.K.00521.
Other Identifiers
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CMRPG8D1051
Identifier Type: -
Identifier Source: org_study_id
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