Clinical trial NCT04085575: Efficacy of Intra-auricular Tranexamic Acid in Total Knee Arthroplasty
Official title: Efficacy of 1g Versus 2g Intra-auricular Tranexamic Acid in Postoperative Bleeding After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Hemorrhage
Lead sponsor: Centre Hospitalier de Montauban
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: They were assigned in two groups: The G1 group received 1 g of intra-articular tranexamic acid (TXA) and the G2 group received 2 g of intra-articular tranexamic acid. Both groups 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.
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Blood loss in postoperative drainage.
timeFrame: Blood loss in 24 hours postoperative drainage
Secondary outcomes:
measure: The change in hematocrit levels
timeFrame: change in hematocrit levels at 24 and 72 hours
measure: The change in hemoglobin levels
timeFrame: change in hemoglobin levels at 24 and 72 hours
Other outcomes:
Locations:
city: Montauban
country: France
facility: Edmundo Pereira de Souza Neto
state: Tarn Et Garonne
Study officials:
References:
citation: 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.