Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty

Phase 2

Completed

• Conditions: Arthrosis
• Interventions: Drug: Tranexamic Acid - topical; Drug: Placebo; Drug: Tranexamic Acid - intravenous

• Registration Number: NCT02323373
• Lead Sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-23
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-12
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical group	Tranexamic Acid - topical	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.
Placebo	Placebo	Intervention: intravenous injection of 100 ml of saline solution also administered with anesthesia in 10 minutes.
Intravenous group	Tranexamic Acid - intravenous	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.

Primary Outcome Measures

Name	Time	Method
Blood loss	up to 48 hours from the end of surgery, with drained volume registered every 6 hours.	Volume of blood loss in the suction drain device after TKA surgery

Secondary Outcome Measures

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