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Completed

NCT Number: NCT04085575

Efficacy of Intra-auricular Tranexamic Acid in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Edmundo Pereira de Souza Neto

Montauban, Tarn Et Garonne, 82000, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acide Tranexamique

Drug

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

Primary outcomes

  1. Blood loss in postoperative drainage.

    Time frame: Blood loss in 24 hours postoperative drainage

    The primary endpoint was the bleeding represented by blood loss in postoperative drainage.

Secondary outcomes

  1. The change in hematocrit levels

    Time frame: change in hematocrit levels at 24 and 72 hours

    The secondary outcomes were the change in hematocrit levels.

  2. The change in hemoglobin levels

    Time frame: change in hemoglobin levels at 24 and 72 hours

    The secondary outcomes were the change in hemoglobin levels.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Montauban

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 11, 2019
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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