Tranexamic Acid for Total Knee Arthroscopy

Study Overview
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Brief Summary
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The purpose of this investigation is to determine the most effective regimen of administration of tranexamic acid to improve clinical outcome among patients undergoing total knee arthroplasty.

Detailed Description
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Tranexamic acid (TXA) is synthetic lysine analog, which acts as anti-fibrinolytic agent by preventing conversion of plasminogen in to plasmin. Various regimens of TXA administration (routes, doses, timing) have been used to decrease perioperative blood loss and improve clinical outcomes among patients undergoing different orthopedic surgeries. We are conducting this prospective randomized placebo controlled trial to compare the effect of the two most common regimens of TXA administration on hemostasis and clinical outcomes among patients undergoing total knee arthroplasty. All recruited patients receive the first dose of 15mg/kg of IV TXA prior to skin incision. The second dose of 15mg/kg IV TXA or identical placebo is administered prior to the release of the tourniquet. The assessment of hemostasis is performed using whole blood sample via viscoelastic testing by rotational thromboelastography (ROTEM). A blood sample is collected in the preoperative area and after the administration of each dose of TXA. Clinical data is collected until 90 days after surgery.

Official Title
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Comparison of the Effect of Two Common Regimens of Administration of Tranexamic Acid on Hemostasis and Clinical Outcome of Patients Undergoing Total Knee Arthroplasty

Conditions
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Blood Loss, Surgical

Intervention / Treatment
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* Drug: Tranexamic acid (TXA)
* Drug: Placebo Normal Saline (NS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Adult patients who are scheduled to undergo total knee arthroplasty will be approached to participate. Exclusion Criteria: Known allergy to TXA History of venous or arterial thrombosis within 12 months History of thromboembolic event within 12 months Acute ischemic event (stroke, transient ischemic attack, myocardial infarction, ischemic retinopathy) within 6 months Known congenital thrombophilia Relative Contraindications: History of seizures Impaired kidney function (Glomerular filtration rate < 30 ml/min)

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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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 |
| --- | --- |
| Active Comparator: Tranexamic acid (TXA)<br>All patients will receive 15 mg/kg Tranexamic acid (TXA) IV prior to skin incision. This arm will receive a second intravenous dose of 15 mg/kg of Tranexamic acid (TXA) before the release of the tourniquet. The medication is delivered from the pharmacy in a masked syringe labeled as study medication. | Drug: Tranexamic acid (TXA)<br>* Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups<br>* Other names: Cyklokapron;|
| Placebo Comparator: Placebo Normal Saline (NS)<br>All patients will receive 15 mg/kg Tranexamic acid (TXA) IV prior to skin incision. This arm will receive a second intravenous dose of placebo (Normal Saline) in the volume calculated to be equal to the volume of 15 mg/kg of TXA. The medication is delivered from the pharmacy in a masked syringe labeled as study medication. | Drug: Placebo Normal Saline (NS)<br>* Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups<br>* Other names: Sodium chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of changes in hemostasis via viscoelastic testing. | To compare the magnitude of lysis via lysis indexes. | intraoperative (min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit | The comparison of hematocrit recordings from preoperative period to the postoperative period | postoperative day 1 | 
| Length of Hospitalization | Length of hospital stay from day of surgery to discharge from hospital. | up to 7 days | 
| The number of blood transfusions | The number of blood products transfused after surgery | 90 days | 
| Hospital readmissions | The occurrence of hospital readmissions following surgery | 90 days |