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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-18

Study Completion Date

2017-03-14

Brief Summary

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

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Detailed Description

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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

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Knee Prosthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tranexamic acid

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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type 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.

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

Adrenalin

Intervention Type DRUG

Interventions

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Tranexamic Acid

Intervention Type DRUG

Adrenalin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No