Tranexamic Acid for Unilateral Total Knee Arthroplasty

Study Overview
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Brief Summary
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Total knee arthroplasty is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to determine the peri-operative bleeding comparing the application of topical and intravenous tranexamic acid with the habitual surgical haemostasis.

Detailed Description
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Objectives: Principal: To assess if the topical and intravenous tranexamic acid reduce less or at least than 20% the blood losses with respect to the habitual haemostasia in patients, after unilateral total knee arthroplasty. Secondary: To assess the treatment safety. To perform a cost- analyses. Methods: Randomized, multicentre, open and parallel clinical trial with three comparative groups: Topical tranexamic acid, Intravenous tranexamic acid and habitual haemostasia. In all patients, a single drainage of 8mm will be inserted in the joint, and it will remain closed during one hour after the closure of the skin. Nº of participant centres: 2. Random allocation will be centralised in Hospital de la Santa Creu i Sant Pau. Main outcome: Total blood loss (mL) in the post-operative period collected by the habitual drain system ). Secondary outcomes: Total blood loss (mL)and hidden blood calculated by Nadler's formula. Proportion of patients with blood transfusion, complications of surgery wound, haemoglobin pre and post-operative, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.Direct cost analysis. Substudy: Pharmacokinetic study. The first 24 patients included in Hospital de la Santa Creu i Sant Pau for tranexamic acid (12 topical- 12 intravenous) to determine: Plasmatic concentrations of tranexamic acid In topical and intravenous tranexamic acid administration determine the absorption rate and drug bioavailability by these routes: maximum plasma concentration, time to reach Cmax, AUC, and half-life.

Official Title
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Prevention of Postoperative Blood Loss: Randomised Multicentre Parallel Clinical Trial That Assess the Topical and Intravenous Tranexamic Acid in Surgical Patients With a Total Knee Arthroplasty.

Conditions
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Blood Loss

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral Total knee arthroplasty The patient consent to participate Exclusion Criteria: Antecedent of thromboembolic disease Patient with cardiac alterations of the rhythm Patients with valvular cardiac prosthesis Patients with pro-thrombotic alterations of coagulation Treatment with anticonceptive drugs

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br>Intravenous Tranexamic Acid Two dosage Tranexamic acid during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage. Each dosage: 2 ampoules of 500mg/5 mL/ampoule Other Name: Amchafibrin | Drug: Tranexamic Acid<br>* Two dosage during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage. Each dosage: 2 ampoules of 500mg/5 mL/ampoule<br>* Other names: Amchafibrin;Other: haemostasia<br>* The surgical habitual haemostasia: electrocoagulation of the bleeding tissues<br>|
| Active Comparator: Habitual haemostasia<br>The surgical habitual haemostasia. | Other: haemostasia<br>* The surgical habitual haemostasia: electrocoagulation of the bleeding tissues<br>|
| Experimental: Topical Tranexamic acid<br>Topical Tranexamic acid one dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser. | Drug: Tranexamic Acid<br>* One dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.<br>* Other names: Amchafibrin;Other: haemostasia<br>* The surgical habitual haemostasia: electrocoagulation of the bleeding tissues<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood loss (mL) | Blood will be collected by drainages during the first 24 hours after surgery. | at 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hidden blood loss | Hidden blood loss will be calculated by Nadler's formula | From admission to hospital until an average of 5 days postoperative period | 
| Wound complications | We will quantify infections, haematomas and other complications related with surgery | 5 weeks postoperatively | 
| Adverse effect related with the interventions | Any adverse effects related with tranexamic acid will be collected | 5 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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topical, primary knee arthroplasty, tranexamic acid