Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty (TRANEXTKA)

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

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

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.

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.

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.

Intervention: intravenous injection of 100 ml of saline solution also administered with anesthesia in 10 minutes.

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.

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.

during or after surgery, during hospital stay (hospital discharge took place in four days, in average)

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.