Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKA

Study Overview
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Brief Summary
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The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled, randomized, double blind clinical trial that compare efficacy and safety of topical TA versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).

Detailed Description
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The groups will be compared by ITT and PP. The non-inferiority would be estimated by comparing the confidence interval using the traditional test, and Wilson test.

Official Title
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Efficacy of Topical Tranexamic Acid Versus Intravenous Administration to Reduce Blood Transfusion Rate in Total Knee Arthroplasty Surgery: Phase III, Unicentric, Controlled,Double Blind, Randomized Non Inferiority Clinical Trial.

Conditions
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Blood Loss

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (greater than 18 years old) Patients scheduled for primary unilateral knee arthroplasty Patients for La Paz- Cantoblanco Hospital, Madrid, Spain Exclusion Criteria: Patients that refuse to sign the Inform Consent Allergy to tranexamic acid Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; severe EPOC; renal dysfunction (plasma creatinine>2mg/dL if mens and >1.8mg/dL if woman); or hepatic disfunction. Coagulopathy (preoperative platelet count <150,000/mm3, INR>1.4, prolonged PPT(>1.4 x normal) History of thromboembolic disease: CVA, DVT, PE Blood dyscrasias Retinopathy (disturbances of color vision) Jehovah's witnesses Pregnancy Breastfeeding Been participating or been participated a year ago in another clinical trial

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Topical administration of 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride) as follow: 50mL by irrigation before wound closure 50mL by intraarticular administration (Drenofast) after wound closure. Intravenous administration of Normal saline (0.9% sodium chloride) as follow: 100mL before tourniquet realised 100mL 3 hours after surgery | Drug: Tranexamic Acid<br>* Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)<br>* Other names: AMCHAFIBRIN;|
| Active Comparator: Comparator<br>Topical administration of Normal saline (0.9% sodium chloride) as follow: 50mL by irrigation before wound closure 50mL by intraarticular administration (Drenofast) after wound closure Intravenous administration of two dosis of Tranexamic Acid as follow: 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), before tourniquet realised 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), 3 hours after surgery | Drug: Tranexamic Acid<br>* Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each)<br>* Other names: AMCHAFIBRIN,;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion rate | Number of transfused patients in each arm/Total number of patients in each arm | participants will be followed for the duration of hospital stay, an expected average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visible blood loss | Number of milliliters drained in Redon after 24 hours post OP | 24 hours after surgery | 
| Invisible blood loss | Number of milliliters estimated with Nedler formula 48 hours after surgery. Invisible blood loss= 75*weight(Kg)*[(Hb0-Hb1)/Hb0]+ blood transfused(mL) | 48 hours after surgery | 
| Surgery infection rate | Percent of patients with proved signs of infection during the hospital stay Percent of patients with proved signs of infection one month after surgery(safety reasons) | One month after surgery | 
| Range of motion | - Range (in degrees) from full extension to full flexion during the hospital stay | participants will be followed for the duration of hospital stay, an expected average of 5 days | 
| Prevalence of drug-related adverse events | Rate and characteristics of the adverse events during the hospital stay | participants will be followed for the duration of hospital stay, an expected average of 5 days | 
| Rate of PE | Percent of PE during the hospital stay Percent of PE one month after surgery(safety reasons) | One month after surgery | 
| Rate of DVT | Percent of DVT during the hospital stay Percent of DVT one month after surgery(safety reasons) | One month after surgery | 
| Rate or Thrombophlebitis | Percent of Thrombophlebitis during the hospital stay Percent of Thrombophlebitis one month after surgery(safety reasons) | One month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, TKA, blood loss