Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty

Study Overview
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Brief Summary
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This is a randomized, double blinded, controlled trial in patients undergoing elective Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). The study group will receive intra-articular Tranexamic Acid (TXA) while the control group will receive normal saline placebo.

Detailed Description
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The primary purpose of this study is to determine if intra-articular administration of low dose TXA following THA and TKA results in a clinically relevant reduction in blood loss. The secondary purpose is to determine if there is an increased risk of thromboembolic phenomena with the use of TXA following elective THA and TKA. The primary outcome metric will be - drop in hemoglobin following surgery; secondary metrics include blood loss, transfusion rate, d-dimers, troponin levels, symptomatic deep venous thrombosis (DVT) and pulmonary embolism (PE), vascular events (myocardial infarction, stroke), major and minor bleeding, and death.

Official Title
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Role of Low Dose Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty: A Randomized Placebo Controlled Study

Conditions
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Osteoarthritis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: with osteoarthritis scheduled for elective primary unilateral THR or TKR provided informed consent can read, write and speak English Exclusion Criteria: history of arterial or venous thromboembolic disease (myocardial infarction, symptomatic ischemic heart disease, atrial fibrillation, cerebrovascular accident, deep-vein thrombosis, pulmonary embolus, or thrombogenic cardiac valvular disease or rhythm disease) pre-operative Hg of <120 g/L Known allergy to Tranexamic Acid Coagulation disorder Acquired disturbances of color vision Hepatic insufficiency, any history of liver disease Renal insufficiency (on dialysis) Preoperative prophylactic use of antiplatelet or anticoagulant therapy such as Clopidogrel, Warfarin, dabigatran or Rivaroxaban. This does not include low dose Aspirin (81mg) Patients with a history of subarachnoid hemorrhage [20] Simultaneous bilateral THA or TKA Any contra-indication for spinal anesthesia Allergy to Celecoxib, which will be the only nonsteroidal anti-inflammatory drugs (NSAID) used in the multi-modal analgesia regime. Retinal vein or retinal artery occlusion Female on oral contraceptive pills and/or premenopausal Concurrently taking hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine and/or nitroglycerin for the duration of the surgery.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid<br>Intra-articular administration of low dose Tranexamic acid | Drug: Tranexamic Acid<br>* 0.5g Tranexamic Acid in 0.9% Sodium Chloride (study group) will be injected into the joint after final closure through a temporary catheter that is brought out through the incision.<br>* Other names: DIN#: 02246365, Sandoz Canada Inc.;|
| Placebo Comparator: Placebo<br>Sodium Chloride | Other: Placebo<br>* 0.9% Sodium Chloride (placebo group) will be injected into the joint after final closure through a temporary catheter that is brought out through the incision.<br>* Other names: Sodium Chloride solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in hemoglobin during hospital stay |  | routinely measured post-op day 1 and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Troponin |  | Every 6 hours for 24 hours post-op | 
| D-dimer |  | Post-op day 1 and 2 |