Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty

Study Overview
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Brief Summary
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This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR).

Detailed Description
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Tranexamic Acid (TXA) is given to stop or reduce heavy bleeding. It works by stopping clots from breaking down and by decreasing unwanted bleeding. It is used in many types of surgeries to help reduce surgical complications such as blood loss and blood transfusions. In orthopaedic surgeries, such as in total hip and knee replacements, TXA has been shown to effectively reduce blood loss and transfusion requirements without an increased risk of side effects such as deep venous thrombosis (DVT) or pulmonary embolism (PE). The ability to decrease blood loss is crucial, as other studies have shown that reducing blood loss decreases morbidity and mortality in patients. Although, many TXA dosing regimens have been studied - all of which have been useful at reducing blood loss and decreasing transfusion requirements - the best TXA dosing regimen and the most cost-effective method of TXA administration for patients have yet to be determined. Moreover, a thorough and rigorous study on the use and effects of topical and intravenous TXA and the effect of TXA on patient outcomes has yet to be conducted. Therefore, this research study aims to address those concerns in order to understand how best to use TXA to reduce surgical complications in patients undergoing total joint replacements.

Official Title
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Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty

Conditions
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Blood Loss

Intervention / Treatment
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* Drug: Intravenous Placebo
* Drug: Intravenous Tranexamic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria All patients 18 years and older who are already scheduled for primary total joint arthroplasty of the hip or knee Exclusion Criteria for IV TXA administration Cardiac stent or ischemic stroke or coronary artery bypass graft (CABG) If patient is on anticoagulant, patient must have documented approval from a cardiologist that patient can be removed from anticoagulant for total joint arthroplasty procedure Renal impairment defined as serum Cr > 1.5 or Cr Clearance < 50 mL/min Severe ischemic heart disease Color blindness or problems with color vision Criteria for Use of Topical TXA Topical TXA can be used in any patient meeting one of the exclusion criteria for IV TXA administration (Section 5.3b) as there is minimal systemic absorption with topical TXA Absolute Exclusion Criteria History of deep vein thrombosis (DVT) or pulmonary embolism (PE) Known congenital thrombophilia History of thromboembolic or vascular disease Disseminated intravascular coagulation (DIC) History of seizures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Tranexamic Acid<br>1g TXA administered intravenous piggyback at start of surgery OR 1g TXA administered intravenous piggyback at start and at time of closure of surgery | Drug: Intravenous Tranexamic Acid<br>* 1g TXA IVPB (intravenous piggyback)<br>* Other names: Tranexamic Acid;|
| Placebo Comparator: Intravenous Placebo<br>- IV 0.9% sterile saline | Drug: Intravenous Placebo<br>* IV 0.9% sterile saline<br>* Other names: Saline;|
| Active Comparator: Intravenous Tranexamic Acid followed by Intravenous Placebo<br>1g TXA administered intravenous piggyback at start of surgery OR 1g TXA administered intravenous piggyback at start and at time of closure of surgery IV 0.9% sterile saline | Drug: Intravenous Placebo<br>* IV 0.9% sterile saline<br>* Other names: Saline;Drug: Intravenous Tranexamic Acid<br>* 1g TXA IVPB (intravenous piggyback)<br>* Other names: Tranexamic Acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Required a Blood Transfusion During Surgery | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. | operative period (average of 1 hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Levels of Hematocrit: Pre-operative to Post-operative | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. | Day 3 or 4 post surgery | 
| Length of Hospital Stay | Measured in Days | At Hospital Discharge | 
| Estimated Blood Loss During Surgery | Surgeon estimated blood loss | Operative period (an average of 1 hour) | 
| Change in Hemoglobin: Pre-operative to Post-operative | Measured in grams/deciliter | Day 3 or 4 post surgery | 
| Walking Distance Post Total Joint Arthroplasty of the Hip | Walking distance (feet) will be assessed and documented throughout the hospital stay | 4 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total hip arthroplasty, Total knee arthroplasty