Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty

Arthrosis Clinical Trial

— TRANEXTKA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323373
• Other study ID #: ISCMSP
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2014
• Last updated: January 12, 2015
• Start date: June 2014
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: Irmandade da Santa Casa de Misericordia de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthrosis

Intervention

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.
• Placebo
100 ml of saline solution administered with anesthesia during 10 minutes
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Irmandade da Santa Casa de Misericordia de Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Thrombosis	Patients with events of thrombosis after TKA	up to 15 days after surgery	No
Secondary	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)	No