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

CHU Brugmann University Hospital

Status and phase: Completed; Early Phase 1

Conditions: Knee Prosthesis

Treatments: Drug: Tranexamic Acid; Drug: Adrenalin

Study type: Interventional

Funder types: Other

Identifiers

NCT02319915

CHUB-PTGexacyl-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Tranexamic acid

Experimental group

Description:

Study of the pharmacokinetic profile of the plasmatic resorption of tranexamic acid after an intra-articular injection.

Treatment:

Drug: Tranexamic Acid

Tranexamic acid + adrenalin

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid

Drug: Adrenalin