Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty

Study Overview
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Brief Summary
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Objectives: a) Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the blood losses with respect to the habitual haemostasia in patients with arthroplasty total of knee. Secondaries: To assess the treatment safety. To perform a cost- analyses. Methods: Randomized, unicentric, and parallel clinical trial with four comparative groups: Tissucol® (fibrin glue), fibrin glue manufactured by the Cryoseal® system (Banc de Sang i Teixits de Catalunya), tranexamic acid and habitual haemostasia. Nº of participant centres: 1. Random allocation will be centralised. Main outcome: Blood losses (ml) in the post-operatory period collected by the habitual drain system. Secondary outcomes: Proportion of patients with blood transfusion, complications of surgery wound, pre and post-operative haemoglobin, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed. Size sample calculation: The number needed of patients is 172 (43 per group) to demonstrate a 20% difference in the post-operative blood losses between the treatments assessed and the habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20% of withdrawals. Statistical analysis: The investigators will perform a comparison of outcomes through the t test, the Mann-Whitney test of chi square, depending of the evaluated outcomes, quantitative or ordinals or qualitative, respectively. The software used will be Statistical Package for the Social Sciences (SPSS) version 17.

Official Title
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Prevention of Postoperative Blood Loss: Randomised Unicentric Parallel Clinical Trial That Assess the Efficacy of Fibrin Glue and Tranexamic Acid in Surgical Patients With a Total Knee Arthroplasty.

Conditions
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Knee Arthropathy

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Fibrin glue
* Biological: Fibrin glue
* Other: Habitual haemostasis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Total knee arthroplasty The patient consent to participate Exclusion Criteria: Intolerance drugs to the study or to bovine protein (aprotinin) 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br>Tranexamic acid is a synthetic derivative of the amino acid lysine. It inhibits fibrinolysis by blocking the lysine binding sites on plasminogen and facilitates the coagulation process. | 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;|
| Experimental: Fibrin glue BSTC<br>It is homologous fibrin glue from a single blood donor. | Biological: Fibrin glue<br>* Topical administration, before to close the surgical wound.<br>|
| Experimental: Tissucol<br>It is fibrin glue commercialized from multiple donors. | Drug: Fibrin glue<br>* Topical administration, before to close the surgical wound. Dosage: 2 mL.<br>* Other names: Tissucol;|
| Other: Habitual haemostasis<br>Electrocoagulation of blood vessels was performed during surgery in all patients (routine hemostasis) | Other: Habitual haemostasis<br>* The surgical habitual haemostasis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative blood loss (mL) | Blood loss (mL) by the surgical wound collected by drain systems. | During the first 48h after the surgical intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients that need a postoperative blood transfusion |  | During the first postoperative week | 
| Percentage of patients with surgical wound infection |  | During the first postoperative month | 
| Percentage of patients with surgical wound dehiscence |  | During the first postoperative month | 
| Percentage of patients with re-intervention by wound complications |  | During the first postoperative month | 
| Incidence of deep venous thrombosis |  | During the first postoperative week | 
| Pain of surgical wound |  | During the first postoperative week | 
| Units of blood transfusion |  | During the first postoperative week | 
| hospital length stay |  | Days | 
| Mortality |  | During the first postoperative month | 

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