Comparison of Topical and Infusion Tranexamic Acid After Total Knee Arthroplasty
Information source: Chang Gung Memorial Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis, Knee
Intervention: Tranexamic Acid 5%,5ml/amp (Drug); Tranexamic Acid 5%,5ml/amp (Drug); rivaroxaban (10mg) (Drug); 0.9% Normal Saline (Drug); 0.9% Normal Saline (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Chang Gung Memorial Hospital Official(s) and/or principal investigator(s): Jun-Wen Wang, MD, Study Chair, Affiliation: Kaohsiung Chang Gung Memorial Hospital
Overall contact: Jun-Wen Wang, MD, Phone: 886-7-7317123, Email: wangjw@adm.cgmh.org.tw
Summary
The purpose of the study, therefore, is to conduct a prospective randomized controlled trial
to investigate the blood-conservation effect of TXA in different TKA patients groups with
rivaroxaban for VTE prophylaxis, first group by topical application, second group by
infusion and a third group of placebo and observe whether there is difference in the
occurrence of venous thromboembolism in those patient groups by venographic study
Clinical Details
Official title: Comparison of Topical and Infusion Tranexamic Acid on Blood Loss and Risk of Deep Vein Thrombosis After Total Knee Arthroplasty
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of any deep-vein thrombosis, non-fatal pulmonary embolism, or all-cause mortalityIncidence of major bleeding after the first dose of rivaroxaban and all death related to postoperative bleedings
Secondary outcome: Incidence of major venous thromboembolismSecondary safety outcome was composite of any non-major bleeding and all wound complications after operation Incidence of wound complications after surgery Total blood loss after surgery
Detailed description:
Investigators previous experiences in minimally invasive (MIS) TKA showed that
intraoperative infusion of TXA reduced 45% of postoperative blood loss and needs for
transfusion from 20% to 4%. However, most of the orthopedic surgeons still hesitate to use
TXA systemically in TKAs especially in high risk patients with a potential increase in
thromboembolic events following surgery.
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.
Eligibility
Minimum age: 50 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- End-stage arthritis of the knee
- Failure of medical treatment or rehabilitation
- Hemoglobin > 10g/dl
- No use of non-steroid anti-inflammatory agent one week before operation
Exclusion Criteria:
- Preoperative Hemoglobin ≦10 g/dl
- 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
Locations and Contacts
Jun-Wen Wang, MD, Phone: 886-7-7317123, Email: wangjw@adm.cgmh.org.tw
Kaohsiung Chang Gung Memorial Hospital, Koahsiung, Taiwan; Not yet recruiting Jun-Wen Wang, MD, Phone: 886-7-7317123, Email: wangjw@adm.cgmh.org.tw
Additional Information
Related publications: Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Pérez-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.
Starting date: June 2015
Last updated: May 26, 2015
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