Topical Tranexamic Acid (TXA) in Joint Arthroplasty

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.

Official Title
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Topical Application of Tranexamic Acid in Joint Arthroplasty

Conditions
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Osteoarthritis, Hip Arthropathy, Shoulder Arthropathy

Intervention / Treatment
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* Biological: Tranexamic acid (TXA)
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Shoulders: All adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study. Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study. Exclusion Criteria: allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance <30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin <11g/dl in females and < 12g/dl in males).

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical Tranexamic acid (TXA)<br>Tranexamic acid (TXA) applied topically | Biological: Tranexamic acid (TXA)<br>* 1.5g of TXA in 100ml normal saline solution<br>* Other names: Cyklokapron;|
| Placebo Comparator: Saline<br>Normal saline | Drug: Normal saline<br> <br> |
| Active Comparator: Tranexamic acid (TXA)<br>Tranexamic acid (TXA) administered intravenously | Biological: Tranexamic acid (TXA)<br>* 1.5g of TXA in 100ml normal saline solution<br>* Other names: Cyklokapron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Blood Loss | Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion. | Duration of hospital stay, up to 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Perioperative Blood Transfusions |  | Duration of hospital stay, up to 4 days | 
| Number of Blood Units Transfused |  | Duration of hospital stay, up to 4 days | 
| Rate of Surgical Infections |  | Duration of hospital stay, up to 4 days | 
| Length of Hospital Stay |  | Duration of hospital stay | 
| Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE). | Single Assessment Numeric Evaluation (SANE): A single question that asks How would you rate your hip today as a percentage of normal (0% to 100% scale with 100% being normal)? 0 indicates an abnormal shoulder, whereas 100% indicates a perfectly normal shoulder. Euroqol-5D (EQ-5D): The EQ-5D is a patient-reported overall health questionnaire, with 100 indicating The best health you can imagine and 0 indicating The worst health you can imagine. Global Rating of Change Scale (GRoC): Provide a means of measuring self-perceived change in health status. The main purpose is to quantify the extent to which a patient has improved or deteriorated over time. The outcome is measured on a scale of -7 to 7, with -7 being the hip is a very great deal worse from before surgery and 7 being the hip is a very great deal better from before surgery. | 6 months post-surgery | 
| Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Harris Hip Score: Consists of 10 question items evaluating pain, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing less dysfunction and better outcomes, whereas lower scores represent more dysfunction and worse outcomes. Western Ontario and McMaster Universities Arthritis Index (WOMAC): Consists of 24 questions evaluating hip pain, stiffness and function. The score is normalized to a 100 point scale, where 0 indicates a poor outcome and 100 indicates the best outcome. | 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid (TXA)