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.

Study Overview

• Status: Completed
• Conditions: Arthrosis
• Intervention / Treatment: Drug: Tranexamic Acid - topical; Drug: Tranexamic Acid - intravenous; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical group; 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; 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.; Other Names: trans-4-(aminomethyl)cyclohexanecarboxylic acid
Active Comparator: Intravenous group; 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; 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.; Other Names: trans-4-(aminomethyl)cyclohexanecarboxylic acid
Placebo Comparator: Placebo; Intervention: intravenous injection of 100 ml of saline solution also administered with anesthesia in 10 minutes.	Drug: Placebo; 100 ml of saline solution administered with anesthesia during 10 minutes; Other Names: Saline solution

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo
• Investigators: Principal Investigator: Zekcer Ari, MD, PhD, Santa Casa de São Paulo

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Estimate): January 14, 2015
• Last Update Submitted That Met QC Criteria: January 12, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Drug Administration Routes; Tranexamic Acid; Arthroplasty, Replacement, Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: ISCMSP