NCT02319915

Evaluation of the Pharmacokinetic Profile of Tranexamic Acid, After Injection in a Knee Neo-articulation.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Brugmann University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the pharmacokinetic profile of tranexamic acid injected intra-articularly with or without adrenaline, in a population of patients undergoing knee replacement.

Detailed description

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.

Conditions

• Knee Prosthesis

Interventions

Type	Name	Description
DRUG	Tranexamic Acid
DRUG	Adrenalin

Timeline

• Start date: 2015-02-18
• Primary completion: 2017-03-14
• Completion: 2017-03-14
• First posted: 2014-12-18
• Last updated: 2018-01-19

Locations

1 site across 1 country: Belgium