Prevention of Postoperative Blood Loss: Randomised Multicentre Parallel Clinical Trial That Assess the Topical and Intravenous Tranexamic Acid in Surgical Patients With a Total Knee Arthroplasty.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Total blood loss (mL)
研究概览
简要总结
Total knee arthroplasty is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to determine the peri-operative bleeding comparing the application of topical and intravenous tranexamic acid with the habitual surgical haemostasis.
详细描述
Objectives:
- Principal: To assess if the topical and intravenous tranexamic acid reduce less or at least than 20% the blood losses with respect to the habitual haemostasia in patients, after unilateral total knee arthroplasty.
- Secondary: To assess the treatment safety. To perform a cost- analyses.
Methods: Randomized, multicentre, open and parallel clinical trial with three comparative groups: Topical tranexamic acid, Intravenous tranexamic acid and habitual haemostasia. In all patients, a single drainage of 8mm will be inserted in the joint, and it will remain closed during one hour after the closure of the skin.
Nº of participant centres: 2. Random allocation will be centralised in "Hospital de la Santa Creu i Sant Pau".
Main outcome: Total blood loss (mL) in the post-operative period collected by the habitual drain system ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral Total knee arthroplasty
- •The patient consent to participate
排除标准
- •Antecedent of thromboembolic disease
- •Patient with cardiac alterations of the rhythm
- •Patients with valvular cardiac prosthesis
- •Patients with pro-thrombotic alterations of coagulation
- •Treatment with anticonceptive drugs
研究组 & 干预措施
Tranexamic acid
Intravenous Tranexamic Acid Two dosage Tranexamic acid during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage.
Each dosage: 2 ampoules of 500mg/5 mL/ampoule Other Name: Amchafibrin
干预措施: Tranexamic Acid (Drug)
Tranexamic acid
Intravenous Tranexamic Acid Two dosage Tranexamic acid during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage.
Each dosage: 2 ampoules of 500mg/5 mL/ampoule Other Name: Amchafibrin
干预措施: haemostasia (Other)
Habitual haemostasia
The surgical habitual haemostasia.
干预措施: haemostasia (Other)
Topical Tranexamic acid
Topical Tranexamic acid one dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.
干预措施: Tranexamic Acid (Drug)
Topical Tranexamic acid
Topical Tranexamic acid one dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.
干预措施: haemostasia (Other)
结局指标
主要结局
Total blood loss (mL)
时间窗: at 24 hours postoperatively
Blood will be collected by drainages during the first 24 hours after surgery.
次要结局
- Hidden blood loss(From admission to hospital until an average of 5 days postoperative period)
- Wound complications(5 weeks postoperatively)
- Adverse effect related with the interventions(5 weeks postoperatively)