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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Withdrawn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
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 30, 2015
    Last Updated
    May 29, 2018
    Sponsor
    Albert Einstein College of Medicine
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    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    Withdrawn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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