Comparison of Topical and Infusion Tranexamic Acid After Total Knee Arthroplasty

NCT02453802 | Unknown Phase 4 DMC

• 1 other identifier: CMRPG8D1051
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Osteoarthritis, Knee

Keywords

Tranexamic Acid; Total Knee Arthroplasty; Rivaroxaban

Outcome Measures

Primary Outcomes (2)

• Incidence of any deep-vein thrombosis, non-fatal pulmonary embolism, or all-cause mortality

  Primary efficacy outcome is the composite of any deep-vein thrombosis, non-fatal pulmonary embolism, or all-cause mortality

  within 15 days after surgery (2 days after the last dose of rivaroxaban )

• Incidence of major bleeding after the first dose of rivaroxaban and all death related to postoperative bleedings

  Primary safety outcome is the composite of major bleeding after the first dose of rivaroxaban and all death related to postoperative bleedings Major bleeding was defined as bleeding that was fatal, that involved a critical organ, or that required reoperation or clinically overt bleeding outside the surgical site that was associated with a decrease in the hemoglobin level of 2 g or more per deciliter or requiring infusion of 2 or more units of blood

  within 15 days after surgery (2 days after the last dose of rivaroxaban )

Secondary Outcomes (4)

• Incidence of major venous thromboembolism

  within 15 days after surgery (2 days after the last dose of rivaroxaban )

• Secondary safety outcome was composite of any non-major bleeding and all wound complications after operation

  within 15 days after surgery (2 days after the last dose of rivaroxaban )

• Incidence of wound complications after surgery

  within 30 days of the procedure

• Total blood loss after surgery

  From the operation to the postoperative day 4

Other Outcomes (2)

• Incidence of venographic positive deep-vein thrombosis (any, proximal, distal)

  on the second day after last dose of rivaroxaban (postoperative day 15)

• Incidence of positive finding of pulmonary embolism by computed tomography

  on the second day after last dose of rivaroxaban (postoperative day 15)

Study Arms (3)

Topic TXA group

ACTIVE COMPARATOR

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

Drug: Tranexamic Acid 5%,5ml/amp; Drug: rivaroxaban (10mg); Drug: 0.9% Normal Saline

IV TXA group

ACTIVE COMPARATOR

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

Drug: Tranexamic Acid 5%,5ml/amp; Drug: rivaroxaban (10mg); Drug: 0.9% Normal Saline

Control group

PLACEBO COMPARATOR

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

Drug: rivaroxaban (10mg); Drug: 0.9% Normal Saline

Interventions

Tranexamic Acid 5%,5ml/amp DRUG

Intraarticular application of tranexamic acid 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule

Also known as: Transamine

Topic TXA group

rivaroxaban (10mg) DRUG

Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.

Also known as: Xarelto

Control group; IV TXA group; Topic TXA group

0.9% Normal Saline DRUG

Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet

Also known as: 0.9% sodium chloride

Control group; Topic TXA group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Koahsiung, Taiwan, Taiwan

Location

Related Publications (10)

• 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.

  PMID: 25471907 BACKGROUND

• 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.

  PMID: 21286886 BACKGROUND

• 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.

  PMID: 22733948 BACKGROUND

• 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.

  PMID: 23541868 BACKGROUND

• 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.

  PMID: 24034510 BACKGROUND

• 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: 23886406 BACKGROUND

• 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.

  PMID: 23906869 BACKGROUND

• 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.

  PMID: 18579812 BACKGROUND

• 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.

  PMID: 19411100 BACKGROUND

• 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.

  PMID: 22832942 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tranexamic Acid; Tranylcypromine; Rivaroxaban; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Propylamines; Amines; Thiophenes; Sulfur Compounds; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jun-Wen Wang, MD

  Chang Gung Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Jun-Wen Wang, MD

CONTACT

886-7-7317123; wangjw@adm.cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 27, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

TW (1)