Role of Topical Tranexamic Acid in Total Hip Arthroplasty

Study Overview
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Brief Summary
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Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss, requiring blood transfusions in some patients. The major cause of this blood loss is due to surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent that reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous form has been extensively studied and shown to be efficacious in cardiothoracic, spine surgical procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical tranexamic acid has been associated with decreased blood loss in cardiac surgeries as well. Recently, results from a prospective randomized study on the topical use of tranexamic acid in total knee arthroplasty found it to be effective for reducing postoperative blood loss. Taking all of the above into consideration we have proposed a study to evaluate effects of topical application of tranexamic acid on postoperative blood loss and blood transfusion on patients undergoing total hip arthroplasty. The aim of this study is to evaluate the efficacy of the topical application of tranexamic acid on blood loss in patients undergoing a primary unilateral total hip arthroplasty.

Official Title
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Role of Topical Tranexamic Acid in Total Hip Arthroplasty

Conditions
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Post Operative Blood Loss

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Normal Saline Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years of age. Male or female. Degenerative joint disease of hip joint. Primary uncemented total hip arthroplasty. Willingness to participate in the study, follow up at regular intervals Exclusion Criteria: Known allergy to tranexamic acid History of any acquired disturbances of color vision Preoperative anemia on basis of pre-operative lab work up (a hemoglobin value of <11 g/dL in females and <12 g/dL in males) History of previous myocardial infarction History of arterial or venous thromboembolic disease History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.5, or a prolonged partial thromboplastin time Pregnancy (h/o any missed menstrual periods in a women of reproductive age group) Breastfeeding Refusal of blood products Preoperative use of anticoagulant therapy within five days before surgery Medical issues that may pose complications for surgery and would disqualify patient for surgery regardless of clinical trial (e.g. renal and hepatic failure) Major comorbidities (e.g. severe ischemic heart disease ) Severe pulmonary disease Preoperative blood donation Participation in another clinical trial involving pharmaceutical drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Placebo Comparator: Group 1<br>Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed. | Drug: Normal Saline Solution<br> <br> |
| Experimental: Group 2<br>Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed. | Drug: Tranexamic Acid<br>* Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Blood Loss | Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb. | Pre Op, Post Op Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mid Thigh Circumference | Measurement of the thigh at the half way point between the prominence of the greater trochanter and the lateral epicondyle of the femur. No data recorded at 2 weeks or 6 weeks for this study population. | Pre Op | 
| Harris Hip Scores | Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome. | Preoperative | 
| Harris Hip Scores | Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome. | 2 week | 
| Harris Hip Scores | Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome. | 6 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Loss, Tranexamic Acid, Total Hip Arthroplasty, Post Op, Post Operative, Prevent Post Operative Blood Loss