Evaluation of the Pharmacokinetic Profile of Tranexamic Acid, After Injection in a Knee Neo-articulation.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The pharmacokinetic profile of tranexamic acid
研究概览
简要总结
Evaluate the pharmacokinetic profile of tranexamic acid injected intra-articularly with or without adrenaline, in a population of patients undergoing knee replacement.
详细描述
Orthopedic population, especially during a knee surgery, is at risk of significant bleeding and blood transfusion in the perioperative period. Tissue damage is associated with the activation of a cascade of mechanisms, in which the activation of the fibrinolyse plays an important role. This is why anti-fibrinolytic agents are regularly used in this context to reduce the perioperative bleeding and the use of blood transfusions.
In the majority of cases, tranexamic acid, an analogue agent of lysine, is administered by an intravenous injection and more recently, by an intra-articular injection.
Several questions however remain unanswered.
- what is the clearance of this substance ?
- does an intra-articular resorbtion exist, resulting in a plasmatic rate of the substance ? If yes, what is the plasmatic rate ?
- Is the intra-articular effect of tranexamic acid predominant compared to its systemic effect ?
- Does the addition of adrenalin increase the effect of the tranexamic acid by acting on its absorption ?
The efficacy, safety and better administration route of the tranexamic acid remain unknown when injected intra-articularly. The goal of this study is to realize the first pharmacokinetic study after an intra-articular injection of tranexamic acid, alone of along with adrenalin, in a knee neo-articulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •programmed PTG, right or left
- •surgery planned within the CHU Brugmann Hospital (Dr Reynders)
- •ASA I to ASA III
- •Signed informed consent within the patient file
排除标准
- •re-do surgery
- •urgent or multiple surgery
- •ASA IV or higher
- •Patients with a BMI superior or equal to 40
- •Patient is a Jehovah Witness
- •Allergy or contra-indication to tranexamic acid
- •Coagulation troubles, defined as: Platelet count < 80 000/mm3 and/or PTT <70% and/or aPTT >45s and/or Fibrinogen <100mg/dL
- •Preoperatory renal insufficiency defined as Creatinin > 3mg/dL and/or Dialysis patients.
研究组 & 干预措施
Tranexamic acid
Study of the pharmacokinetic profile of the plasmatic resorption of tranexamic acid after an intra-articular injection.
干预措施: Tranexamic Acid (Drug)
Tranexamic acid + adrenalin
Study of the pharmacokinetic profile of the plasmatic resorption of tranexamic acid after an intra-articular injection of tranexamic acid with adrenalin 1/200 000.
干预措施: Tranexamic Acid (Drug)
Tranexamic acid + adrenalin
Study of the pharmacokinetic profile of the plasmatic resorption of tranexamic acid after an intra-articular injection of tranexamic acid with adrenalin 1/200 000.
干预措施: Adrenalin (Drug)
结局指标
主要结局
The pharmacokinetic profile of tranexamic acid
时间窗: 24h
Blood sampling will be performed to establish the pharmacokinetic profile of tranexamic acid. T0 will be defined as the injection time of tranexamic acid. The first blood sampling (T1) will be made 5 minutes after, with the garrot still in place. The garrot will then be loosened and the following blood samplings will take place at 1 minute, 5 minute, 15 minutes, 30 minutes, 1h, 2h, 4h, 8h, 12h and 24h after garrot loosening. 1ml of blood will be taken at each blood sampling. The blood will be placed in a tube suited for chemistry analysis (green tube with gel) and sent directly to the laboratory for analysis.
次要结局
- Knee diameter(12h)
- Blood loss(72h)
- Net weight of the compresses(12h)
- Size of the blood stain on the band aid(12h)
研究者
Philippe VAN DER LINDEN
Pr, MD, Head of clinic
Brugmann University Hospital
