Safety of Topical Tranexamic Acid in Total Joint Arthroplasty in High Risk Patients
Primary Purpose
Pulmonary Embolism, Deep Vein Thrombosis, Stroke
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Embolism
Eligibility Criteria
Inclusion Criteria:
Presence of one or more of seven risk factors for thromboembolic events - Prior DVT, PE, MI, CVA, coronary artery stent placement, CABG, or prothrombotic condition (Factor V Leiden deficiency, protein C deficiency, antiphospholipid syndrome, etc).
Exclusion Criteria:
Simultaneous bilateral, hip resurfacing, partial knee, and revision arthroplasties
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic acid
Control
Arm Description
Investigators will administer topical (1.5g) TXA during total knee arthroplasty and total hip arthroplasty
Outcomes
Primary Outcome Measures
Deep Vein Thrombosis
Pulmonary Embolism
Stroke
Myocardial infarction
Secondary Outcome Measures
Full Information
NCT ID
NCT02644473
First Posted
December 30, 2015
Last Updated
May 29, 2018
Sponsor
Albert Einstein College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02644473
Brief Title
Safety of Topical Tranexamic Acid in Total Joint Arthroplasty in High Risk Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study did not receive IRB approval, so did not start
Study Start Date
February 2016 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate whether there is a difference in symptomatic thromboembolism events in the subset of patients with a history of, or risk factors for thromboembolic disease for topically applied tranexamic acid in total joint arthroplasty.
Detailed Description
Tranexamic acid (TXA) has been used successfully to stop bleeding after dental procedures, removal of tonsils, prostate surgery, heavy menstrual bleeding, and eye injuries, as well as in patients with hemophilia. Intravenous TXA has also been shown to reduce blood loss, reduce transfusion requirements, and decrease length of stay for patients undergoing total knee arthroplasty and total hip arthroplasty. These benefits occur without increasing risks of thromboembolism events such as pulmonary embolism, deep venous thrombosis, myocardial infarctions, and cerebrovascular events in patients without history of, or risk factors for thromboembolic disease. Topical TXA in TJA has also been demonstrated to show the above benefits without any increase risks, as well as systemic absorption of the medication that is below the effective therapeutic plasma concentration.
Preliminary retrospective studies has demonstrated that IV TXA to be safe and effective in patients with risk factors for thromboembolic events and patients with American Society of Anesthesiologists score III or IV.
Currently, there are no prospective studies on the use of either IV or topical TXA in these higher risk patients. The goal of this study is to evaluate whether there is a difference in symptomatic thromboembolism events in the subset of patients with a history of, or risk factors for thromboembolic disease for topically applied TXA in total joint arthroplasty (TJA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Deep Vein Thrombosis, Stroke, Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic acid
Arm Type
Experimental
Arm Description
Investigators will administer topical (1.5g) TXA during total knee arthroplasty and total hip arthroplasty
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Control
Primary Outcome Measure Information:
Title
Deep Vein Thrombosis
Time Frame
1 month
Title
Pulmonary Embolism
Time Frame
1 month
Title
Stroke
Time Frame
1 month
Title
Myocardial infarction
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of one or more of seven risk factors for thromboembolic events - Prior DVT, PE, MI, CVA, coronary artery stent placement, CABG, or prothrombotic condition (Factor V Leiden deficiency, protein C deficiency, antiphospholipid syndrome, etc).
Exclusion Criteria:
Simultaneous bilateral, hip resurfacing, partial knee, and revision arthroplasties
12. IPD Sharing Statement
Citations:
PubMed Identifier
10673876
Citation
Jansen AJ, Andreica S, Claeys M, D'Haese J, Camu F, Jochmans K. Use of tranexamic acid for an effective blood conservation strategy after total knee arthroplasty. Br J Anaesth. 1999 Oct;83(4):596-601. doi: 10.1093/bja/83.4.596.
Results Reference
background
PubMed Identifier
22397329
Citation
McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000.
Results Reference
background
PubMed Identifier
22065294
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.
Results Reference
background
PubMed Identifier
24196467
Citation
Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908.
Results Reference
background
PubMed Identifier
25007725
Citation
Huang Z, Ma J, Shen B, Pei F. Combination of intravenous and topical application of tranexamic acid in primary total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Dec;29(12):2342-6. doi: 10.1016/j.arth.2014.05.026. Epub 2014 Jun 5.
Results Reference
background
PubMed Identifier
21048170
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.
Results Reference
background
PubMed Identifier
23817754
Citation
Whiting DR, Gillette BP, Duncan C, Smith H, Pagnano MW, Sierra RJ. Preliminary results suggest tranexamic acid is safe and effective in arthroplasty patients with severe comorbidities. Clin Orthop Relat Res. 2014 Jan;472(1):66-72. doi: 10.1007/s11999-013-3134-0.
Results Reference
background
PubMed Identifier
25257237
Citation
Duncan CM, Gillette BP, Jacob AK, Sierra RJ, Sanchez-Sotelo J, Smith HM. Venous thromboembolism and mortality associated with tranexamic acid use during total hip and knee arthroplasty. J Arthroplasty. 2015 Feb;30(2):272-6. doi: 10.1016/j.arth.2014.08.022. Epub 2014 Sep 6.
Results Reference
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Safety of Topical Tranexamic Acid in Total Joint Arthroplasty in High Risk Patients
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