Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This study evaluates the peri-articular tranexamic acid injection in total knee arthroplasty which is an alternative route of administration for blood loss reduction. Half of participants will receive intravenous tranexamic acid injection, while the other half will receive peri-articular tranexamic acid injection during total knee arthroplasty.

Detailed Description
-----------------
Intravenous tranexamic acid (IV TXA) is one of the most effective agents in use for reducing blood loss following total knee arthroplasty (TKA) but its safety regarding venous thromboembolic events (VTEs) remains in question. The direct, local application of TXA may reduce systemic toxicity whilst maintaining good or better bleeding control compared to IV TXA. The topical application of TXA via Hemovac drains has been reported previously with good results. However, there are no data on peri-articular TXA injections during TKA.

Official Title
-----------------
Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty: A Randomized Controlled Trial

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Drug: Peri-articular tranexamic acid
* Drug: Intravenous tranexamic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
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) know allergy to TXA defective color vision preoperative hemoglobin <10 g/dL platelet count < 140,000 /uL3
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peri-articular group<br>Patients received 750 mg of peri-articular Tranexamic acid (Transamin®; OLIC Thailand Ltd, Bangkok, Thailand; 250 mg/5 mL, 15 cc total volume) injection into the soft tissue around medial capsule (5 ml), lateral capsule (5 ml) and around the quadriceps muscle (5 ml), 10 minutes prior to deflating the tourniquet and wound closure. | Drug: Peri-articular tranexamic acid<br>* 750 mg of peri-articular TXA, prior to deflating the tourniquet and wound closure<br>* Other names: Transamin;|
| Active Comparator: Intravenous group<br>Patients received 750 mg of intravenous tranexamic acid(250 mg/5 ml, 15 cc total volume, keeping within the therapeutic range of 10-15 mg/kg/dose), 10 minutes prior to deflating the tourniquet and wound closure. | Drug: Intravenous tranexamic acid<br>* 750 mg of IV TXA, prior to deflating the tourniquet and wound closure<br>* Other names: Transamin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The volume of postoperative blood loss in the drain |  | 48 hours after the operation | 
| 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 |
| --- | --- | --- |
| Knee diameter for swelling |  | At 24 and 48 hours after the operation | 
| number of patient with venous thromboembolism |  | At 14 days after the operation | 

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