Efficacy of Intra-auricular Tranexamic Acid in Total Knee Arthroplasty

Efficacy of 1g Versus 2g Intra-auricular Tranexamic Acid in Postoperative Bleeding After Total Knee Arthroplasty

Tranexamic acid an antifibrinolytic that develops its anti-haemorrhagic action by inhibiting fibrinolytic activities of plasmin and many studies confirms its effectiveness in decreasing blood loss. The aim of this study was to observe postoperative bleeding with combined intravenous and per - os administration with two intra - articular doses (1 g and 2 g) of tranexamic acid in adult patients undergoing unilateral total knee replacement.

Study Overview

• Status: Completed
• Conditions: Postoperative Hemorrhage
• Intervention / Treatment: Drug: Acide Tranexamique

Detailed Description

Total knee arthroplasty (TKA) is widely used as an effective treatment for end-stage osteoarthritis and other joint diseases of the knee and it improvements in surgical materials and techniques have greatly increased its effectiveness. However, TKA is an orthopaedic surgical method that has a substantial perioperative blood loss.

Classical methods for reducing blood loss and transfusion rate include the use of a pneumatic tourniquet, intraoperative cell saver, hypotensive anesthesia, application of erythropoietin, autologous blood transfusion, plugging of the femoral canal, cementing, drain clamping, navigation and minimally invasive surgery.

Tranexamic acid (TXA) an antifibrinolytic that develops its anti-haemorrhagic action by inhibiting fibrinolytic activities of plasmin has been used as an adjuvant to such measure and many studies with a level of evidence confirms its effectiveness in decreasing blood loss.

Fibrinolysis is stimulated by surgical trauma blood loss and TKA may be related to increased fibrinolytic activity. TXA inhibits fibrinolysis by blocking the lysine-binding sites of plasminogen to fibrin. Plasmin, bound to tranexamic acid, has a considerably diminished activity with respect to fibrin compared to that of free plasmin. Also, it appears from various studies that, in vivo, tranexamic acid at high doses exerts a braking activity on the activation of the complement system. So, TXA reduces bleeding in the TKA and its functional repercussion has also been confirmed in assays for various dosages and routes of administration.

In the literature, efficacy of intra-articular TXA has also been confirmed, but what is the right dosage is now unclear.

The aim of this study was to observe postoperative bleeding with combined intravenous and per - os administration with two intra - articular doses (1 g and 2 g) of tranexamic acid (Sanofi-Aventis® Gentilly, France).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Tarn Et Garonne
    • Montauban, Tarn Et Garonne, France, 82000
      • Edmundo Pereira de Souza Neto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Adult patients undergoing unilateral total knee replacement

Exclusion Criteria:

• Absence of consent
• Tranexamic acid allergy
• Coagulopathy (preoperative platelet count <150,000 / mm3, INR [international normalized ratio]> 1.4, or prolonged partial thromboplastin time> 1.4 times normal),
• History of arterial or venous thromboembolic disease (cerebrovascular accident, deep vein thrombosis or pulmonary thromboembolism),
• Hematological disorder (a hematopoietic, hemorrhagic or thrombogenic disease),
• Retinopathy (severe limitation of the field of vision and / or color distortion),
• Refusal to receive blood products
• Pregnancy
• History of convulsions
• Participation in another clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tranexamic acid - The G1 group; The G1 group received 1 g of intra-articular tranexamic acid (TXA). The G1 group received 15 mg / kg IV at 20 min at induction and then 10 mg / kg in oral administration 6 and 12 hours after induction dose IV of tranexamic acid.	Drug: Acide Tranexamique; Recruited patients were randomly before the operation by generating random numbers with Microsoft Excel 2007. They were assigned in two groups: 1 g of intra-articular tranexamic acid (TXA) and 2 g of intra-articular tranexamic acid.; Other Names: Exacyl
Active Comparator: tranexamic acid - The G2 group; The G2 group received 2 g of intra-articular tranexamic acid (TXA). The G2 group received 15 mg / kg IV at 20 min at induction and then 10 mg / kg in oral administration 6 and 12 hours after induction dose IV of tranexamic acid.	Drug: Acide Tranexamique; Recruited patients were randomly before the operation by generating random numbers with Microsoft Excel 2007. They were assigned in two groups: 1 g of intra-articular tranexamic acid (TXA) and 2 g of intra-articular tranexamic acid.; Other Names: Exacyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss in postoperative drainage.	The primary endpoint was the bleeding represented by blood loss in postoperative drainage.	Blood loss in 24 hours postoperative drainage

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in hematocrit levels	The secondary outcomes were the change in hematocrit levels.	change in hematocrit levels at 24 and 72 hours
The change in hemoglobin levels	The secondary outcomes were the change in hemoglobin levels.	change in hemoglobin levels at 24 and 72 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Montauban

Publications and helpful links

General Publications

• Souza Neto EP, Usandizaga G. [Comparison of two doses of intra-articular tranexamic acid on postoperative bleeding in total knee arthroplasty: a randomized clinical trial]. Braz J Anesthesiol. 2020 Jul-Aug;70(4):318-324. doi: 10.1016/j.bjan.2020.03.015. Epub 2020 Jul 8.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 9, 2019
• Study Completion (Actual): January 9, 2020

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: CHM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The aim of our study was to observe postoperative bleeding with combined intravenous and per - os administration with two intra - articular doses (1 g and 2 g) of tranexamic acid.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No