The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Post-operative bleeding in total knee arthroplasty (TKA) can result in hypovolemic shock and unnecessity for allogenic blood transfusions. Intravenous and topical tranexamic acid (TXA) have been well established in reducing blood loss postoperatively. However, there are lack of data on peri-articular TXA injection during TKA. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial to compare the effectiveness of bleeding reduction of peri-articular TXA injections, intraarticular TXA injections and control group.

Detailed Description
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Patients scheduled for unilateral primary TKA; 108 patients were randomly assigned to receive peri-articular TXA, intraarticular TXA and control group. 36 patients received either: (I) 15 mg/kg peri-articular TXA combined with multimodal local anesthetic infiltration (bupivacaine, morphine, ketorolac and epinephrine) into the anterior soft tissue, medial gutter area, lateral gutter area prior to capsular closure and tourniquet deflation (group 1). (II) 2 g of intraarticular TXA after complete capsular closure just before tourniquet deflation (group 2). (III) Don't receive any route of TXA in control group (group 3). Hemoglobin (Hb) concentrations were measured at 24 and 48 hour, and the number of blood transfusions and knee circumference measurements were recorded. Serum TXA was recorded at 2 and 24 hours after operation. The reviewers were blinded to treatment group.

Official Title
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The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty: A Prospective, Double-Blind Randomized, Controlled Trial

Conditions
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Osteoarthritis,Knee

Intervention / Treatment
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* Drug: Peri-articular TXA (15 mg/kg)
* Drug: Intraarticular TXA 2 g (40 mL)
* Procedure: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area
* Procedure: TXA 40 mL inject into intraaricular knee capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with osteoarthritis in need of a TKA Exclusion Criteria: Inflammatory arthritis Post-traumatic arthritis A history of or current venous thromboembolic disease Any underlying disease of haemostasis, cirrhosis, chronic renal failure, patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel) Preoperative hemoglobin <10 g/dL or a platelet count < 140,000 /uL3 Allergy to TXA

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 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: Peri-articular tranexamic acid injection<br>TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area) | Drug: Peri-articular TXA (15 mg/kg)<br>* combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL<br>Procedure: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area<br>* (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation<br>|
| Experimental: Intraarticular tranexamic acid injection<br>TXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration | Drug: Intraarticular TXA 2 g (40 mL)<br>* inject separate from multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 75 mL)<br>Procedure: TXA 40 mL inject into intraaricular knee capsule<br>* after multimodal local anesthetic infiltration (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to tourniquet deflation<br>|
| No Intervention: Control group<br>Don't receive any route of TXA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline hemoglobin concentrations |  | 48 hours after the operation | 
| Unit of blood transfusion |  | 48 hours after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tranexamic acid level in blood |  | 2 and 24 hours after the operation | 
| Knee diameter for swelling |  | 24 and 48 hours after the operation | 
| Local soft tissue complications |  | 14 days after the operation | 
| Skin necrosis |  | 24 and 48 hours after the operation | 
| Number of patient with venous thromboembolism |  | 14 days after the operation | 
| Visual Analogue Scales | (VAS, 0 = no pain, 10 = the worst imaginable pain) | 24 and 48 hours after the operation | 
| Knee flexion angle |  | 24 and 48 hours after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic acid, Peri-articular injection, Intraarticular injection, Total knee arthroplasty, Blood loss