Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement

Study Overview
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Brief Summary
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The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.

Official Title
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Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement; A Prospective Triple-blinded Randomized Controlled Trial.

Conditions
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Primary Osteoarthritis of Knee Nos

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Physiologic saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed as primary knee osteoarthritis and underwent unilateral primary cemented conventional total knee replacement no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine < 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria) Exclusion Criteria: incomplete data collection, for example, malfunctioned drain or accidental drain removal.

Ages Eligible for Study
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Minimum Age: 50 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 |
| --- | --- |
| Placebo Comparator: Control group<br>physiologic saline 25 ml | Drug: Physiologic saline<br>* Use physiologic saline for mixing with tranexamic acid or use alone in placebo group<br>|
| Active Comparator: TXA-250 group<br>A total of 25-ml solution with 250-mg tranexamic acid | Drug: Tranexamic Acid<br>* Inject tranexamic acid solution intra-articularly after fascia closure<br>* Other names: Transmin;Drug: Physiologic saline<br>* Use physiologic saline for mixing with tranexamic acid or use alone in placebo group<br>|
| Active Comparator: TXA-500 group<br>A total of 25-ml solution with 500-mg tranexamic acid | Drug: Tranexamic Acid<br>* Inject tranexamic acid solution intra-articularly after fascia closure<br>* Other names: Transmin;Drug: Physiologic saline<br>* Use physiologic saline for mixing with tranexamic acid or use alone in placebo group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Blood Loss | Drainage blood loss measured by accumulating total drainage volume postoperatively Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day | 5 days after surgery | 
| Total Hemoglobin Loss | Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day | 5 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Function Scores | Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period. Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better. 1.2. Function score : calculated from patient's ability to walk and climb stairs. The score ranges from 0-100, more score means better. Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better. | 1 year after surgery | 
| Number of Patients Required Blood Transfusion |  | postoperative period (5 days after surgery) | 
| Number of Patients Having Postoperative Complications | Postoperative complications were measured as an incidence of the following complications; wound hematoma surgical site infection systemic infection deep vein thrombosis pulmonary embolism knee stiffness requiring manipulation medical complication such as myocardial infarction, congestive hear failure | postoperative 1-year period |