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临床试验/NCT04085575
NCT04085575已完成4 期

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

Centre Hospitalier de Montauban1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Blood loss in postoperative drainage.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Recruited patients were randomly before the operation by generating random numbers with Microsoft Excel 2007 (Microsoft Corporation, Seattle, Washington, USA).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients undergoing unilateral total knee replacement

排除标准

  • 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.

研究组 & 干预措施

tranexamic acid - The G1 group

Active Comparator

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.

干预措施: Acide Tranexamique (Drug)

tranexamic acid - The G2 group

Active Comparator

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.

干预措施: Acide Tranexamique (Drug)

结局指标

主要结局

Blood loss in postoperative drainage.

时间窗: Blood loss in 24 hours postoperative drainage

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

次要结局

  • The change in hematocrit levels(change in hematocrit levels at 24 and 72 hours)
  • The change in hemoglobin levels(change in hemoglobin levels at 24 and 72 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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