Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty

Study Overview
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Brief Summary
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This clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous.

Detailed Description
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Intravenous administration of tranexamic acid (TA) is common in orthopedic surgery. The ideal dose and administration route of the drug in total knee arthroplasty (TKA) is under investigation. The objective of this randomized clinical trial was to verify differences between topical and intravenous administration of TA in TKA regarding blood loss and coagulation variables. Patients undergoing TKA were randomized to receive TA intravenously (20 mg in 100 ml of saline), topically (1.5 g in 50 ml of saline, sprayed over the operated site, before closure) or intravenous saline (100 ml). Suction drains were maintained for 48 hours, in order to measure blood loss. Data analysis is being undertaken now, in order to compare the two routes of administration of the drug.

Official Title
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Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty: a Randomized Clinical Trial With 90 Patients

Conditions
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Arthrosis

Intervention / Treatment
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* Drug: Tranexamic Acid - topical
* Drug: Placebo
* Drug: Tranexamic Acid - intravenous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in need of unilateral total knee arthroplasty (TKA) due to arthrosis, Albach grades III and IV were eligible Exclusion Criteria: history or identified risk for deep vein thrombosis or pulmonary embolism history of coagulation or cardiovascular disorders vascular diseases pregnancy current use of anticoagulation drugs previous orthopedic surgery in the legs.
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical group<br>Intervention: Tranexamic Acid - topical. Topical administration of a solution of 1.5 g of tranexamic acid (50 mg/ml, Transamin, Zydus Nikkho) diluted in 50 ml of saline (at 0.9%), sprayed over the operated area, covering it for 5 minutes, before the tourniquet release. | Drug: Tranexamic Acid - topical<br>* Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this study arm, the drug is administered topically on the wound.<br>* Other names: trans-4-(aminomethyl)cyclohexanecarboxylic acid;|
| Active Comparator: Intravenous group<br>Intervention: Tranexamic Acid - intravenous Intravenous injection of 20 mg/kg of tranexamic acid, diluted in 100 ml of saline at 0.9%, administered with anesthesia in 10 minutes. | Drug: Tranexamic Acid - intravenous<br>* Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this arm, the drug is administered intravenously.<br>* Other names: trans-4-(aminomethyl)cyclohexanecarboxylic acid;|
| Placebo Comparator: Placebo<br>Intervention: intravenous injection of 100 ml of saline solution also administered with anesthesia in 10 minutes. | Drug: Placebo<br>* 100 ml of saline solution administered with anesthesia during 10 minutes<br>* Other names: Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Volume of blood loss in the suction drain device after TKA surgery | up to 48 hours from the end of surgery, with drained volume registered every 6 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis | Patients with events of thrombosis after TKA | up to 15 days after surgery | 
| Need for transfusion | Number (or percentage) of patients requiring transfusion in TKA surgery | during or after surgery, during hospital stay (hospital discharge took place in four days, in average) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Replacement, Knee, Tranexamic Acid, Drug Administration Routes