Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies: a Randomised Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Perioperative blood loss (haemoglobin balance):
研究概览
简要总结
A randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding, pain and wound complications reduction in tibial osteotomies.
All the 84 included patients will be randomized in one of the two arms, will undergo to a tibial osteotomy and then will prospectively evaluate at different follow ups until 60 days post-surgery
详细描述
Tibial osteotomies represents a well-established treatment option for the medial femorotibial knee arthrosis.
Osteotomy can be performed in minus or in plus, at the latter case with or without interposition of tissue (autologous bone, heterologous bone or bone substitute).
Even though excessive bleeding is not a frequent complication, the blood loss and formation of subcutaneous haematoma can determinate more post-interventional pain, wound suffering and the risk of infections.
Tranexamic acid is an antifibrinolytic agent and its use in proximal tibia osteotomies has been retrospectively evaluated in a number of papers, all of which agree on its safety and efficacy in terms of reducing peri-operative bleeding. However, to date there have been no randomised clinical trials demonstrating its superiority in terms of reducing bleeding, subcutaneous haematoma and wound complications in proximal tibia osteotomies.
This is a randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding , pain and wound complications reduction in tibial osteotomies
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 18 and 70 years;
- •Single-part tibiofemoral osteoarthritis (K-L 1-3), axial deviation > 5°;
- •Surgical indication for corrective osteotomy;
- •Isolated osteotomy surgical procedure.
排除标准
- •Contraindication criteria for the administration of tranexamic acid, as assessed by the Anaesthesia and Resuscitation specialist during the pre-operative visit. The following will be considered absolute contraindications: epilepsy, thrombophilia and known allergy to the active substance, severe renal insufficiency and acute venous or arterial thrombosis, while the following will be considered relative contraindications: coronary stents in patients who have discontinued treatment with antiplatelet agents and previous deep vein thrombosis;
- •Known pro-thrombotic conditions (coagulation factor mutations, pregnancy status, previous pulmonary thromboembolism);
- •Incapacitated patients;
- •Patients abusing alcoholic beverages, drugs or medication.
- •Patients who are pregnant or breastfeeding.
研究组 & 干预措施
Tranexamic arm
Patients in this arm will undergo to a tibial osteotomy in combination with the anti-fibrinolytic agent Tranexamic acid.
干预措施: Tibial osteotomy with Tranexamic acid (Drug)
control arm
Patients in this arm will undergo to a tibial osteotomy without the use of Tranexamic acid
干预措施: Tibial osteotomy without Tranexamic acid (Procedure)
结局指标
主要结局
Perioperative blood loss (haemoglobin balance):
时间窗: Basal vs the first post operative day
The perioperative blood loss will be estimated by assessing the haemoglobin balance on the first postoperative day
次要结局
- Postoperative blood loss(Postoperatively (up to 2 days))
- International Knee Documentation Committee objective(Baseline, 30 and 60 days post treatment)
- Soft tissue status(perioperatively, 30 and 60 days)
- Postoperative transfusion rate(Perioperative time and postoperative time ( up to 60 days))
- Blood loss after discharge(at 5 and 15 days post hospital discharge)
- Visual Analogue Scale - Pain(baseline, 1 day post-treatment, 2 days post-treatment, 1 month, 2 months);)