Knee Prosthesis Clinical Trial
Official title:
Evaluation of the Pharmacokinetic Profile of Tranexamic Acid, After Injection in a Knee Neo-articulation.
Evaluate the pharmacokinetic profile of tranexamic acid injected intra-articularly with or without adrenaline, in a population of patients undergoing knee replacement.
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.
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